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Vitamin Products(2022年11月20日)

pharmasources — 2022-11-10T10:28:25+0900

https://www.pharmasources.com/products/catid/vitamin-5.html

Vitamin is the essential micronutrient which the organism needs in small quantities for the proper functioning of its metabolism. 13 types of vitamin are indispensable for human life activities. 4 of them are fat-soluble vitamins, namely vitamin A, D, E, and K. The remaining 9 types are water-soluble (vitamin C and 8 types of vitamin B). Excessive vitamins can accumulate in the body, resulting in hypervitaminosis. Therefore, the intake amount of vitamins must be strictly controlled. Find reliable vitamin manufacturers at Pharmasources.com

Where are the major sales markets?
The Vitamin on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Sulfonamides Products(2022年11月19日)

pharmasources — 2022-11-10T10:27:44+0900

https://www.pharmasources.com/products/catid/sulfonamides-13.html

Sulfonamides are antibacterial drugs. It can be divided into three types of sulfonamides: the first category is quickly absorbed in the intestines, used to treat sepsis, urinary tract infections, typhoid fever, osteomyelitis, and other diseases; the second category stays in the intestines for a long time to treat the intestines Bacterial infections, such as dysentery; the third category can be used externally for body surface wounds or burns to prevent bacteria from invading.

Where are the major sales markets?
The Sulfonamides on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Prostaglandins Products(2022年11月18日)

pharmasources — 2022-11-10T10:27:07+0900

https://www.pharmasources.com/products/catid/prostaglandins-477.html

Prostaglandin is involved in the proliferation, differentiation, and apoptosis of human cells. It can also help regulate female reproductive and promote childbirth. Furthermore，preventing atherosclerosis and thrombosis is also its function. Scrow down to find different types of prostaglandins.

Where are the major sales markets?
The Prostaglandins on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Phospholipids Products(2022年11月17日)

pharmasources — 2022-11-10T10:26:17+0900

https://www.pharmasources.com/products/catid/phospholipids-15.html

Phospholipids are a very important pharmaceutical excipient, Phospholipids can be divided into glycerophospholipid and sphingolipid according to the skeleton. Glycerolphospholipids can be divided into Phosphatidyl Choline (PC), Phosphatidyl Ethanolamines (PE), Phosphatidyl Serines (PS), Phosphatidyl Inositols (PI), Phosphatidyl Glycerol (PG), Phosphatidic Acid (PA), etc. Phospholipids can control fat metabolism and participate in blood clotting in the human body. Pharmasources provides a complete platform for phospholipid suppliers. Choose the products you’re looking for to find out.

Where are the major sales markets?
The Phospholipids on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Hormones Products(2022年11月16日)

pharmasources — 2022-11-10T10:25:34+0900

https://www.pharmasources.com/products/catid/hormones-9.html

Considerable hormones and structural and functional analogs are used in the medical field. There are different kinds of hormones, commonly used prescribed hormone includes Strogens and Progestogens they are applied as methods of hormonal contraception and as hormone replacement therapy; Thyroxine, used as levothyroxine, for hypothyroidism; And Steroids for autoimmune diseases and several respiratory disorders. In addition, Insulin allows many diabetics to live longer. Pharmacologic equivalents of adrenaline are used as local preparations in otolaryngology, while steroid and vitamin D creams are used extensively in dermatological practice.

Where are the major sales markets?
The Hormones on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Digestive System Drugs Products(2022年11月15日)

pharmasources — 2022-11-10T10:24:53+0900

https://www.pharmasources.com/products/catid/digestive-system-drugs-18.html

Digestive System Drugs List

Digestive System Drugs is used to treat digestive diseases. Common medication for digestive system include drugs for vomiting; Antacids drugs used to prevent ulcers; Drugs promoting ingestion; Gastrointestinal antispasmodics used to inhibit gastrointestinal motility and treat cramps; Laxatives and antidiarrheals used to control bowel movements; Probiotics used to regulate intestines and stomach, treat indigestion; drugs for Hepatobiliary Disease; etc.

Where are the major sales markets?
The Pills for Digestive System on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

We also have kinds of gastrointestinal tract drugs for sale, if you have needs, please contact us.

Central Nervous System Drugs Products(2022年11月14日)

pharmasources — 2022-11-10T10:23:05+0900

https://www.pharmasources.com/products/catid/central-nervous-system-drugs-20.html

The central nervous system (CNS) is the part of the nervous system that consists of the brain and spinal cord. The main nervous system medications are Sedative-hypnotics, which contain barbiturates and benzodiazepines; Antiepileptics; Antipsychotic Drugs which include Antipsychotic drugs and antidepressive drugs; Analgesics, the representative drugs that slow down the central nervous system are morphine Pethidine Hydrochloride and Pentazocine; CNS Stimulants, Caffeine is a common type.

Where are the major sales markets?
The Nervous System Drugs on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Cardiovascular System Drugs Products(2022年11月13日)

pharmasources — 2022-11-10T10:21:49+0900

https://www.pharmasources.com/products/catid/cardiovascular-system-drugs-19.html

Cardiovascular disease (CVD) refers to a series of diseases related to the heart or blood vessels. Cardiovascular System Drugs include antianginal Pectoris drugs, which are used for coronary artery diseases (CAD), like angina and myocardial infarction, scilicet a heart attack. Other anti cardiovascular drugs include antiarrhythmic drugs, antihypertensive drugs, anti cardiac insufficiency drugs, peripheral vasodilators, etc. The cardiovascular agents are Clinical practiced for various CVDS like stroke, heart failure, hypertensive heart disease, rheumatic heart disease, cardiomyopathy, abnormal heart rhythms, congenital heart disease, valvular heart disease, carditis, aortic aneurysms, peripheral artery disease, thromboembolic disease, and venous thrombosis.
Where are the major sales markets?
The Cardiovascular System Drugs on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Antibiotics Products(2022年11月12日)

pharmasources — 2022-11-10T10:20:26+0900

https://www.pharmasources.com/products/catid/antibiotics-8.html

Types of antibiotics are widely used in the treatment and prevention of bacterial infections. Its function is to kill or prevent the growth of microorganisms. Different from fully synthetic nonantibiotic antibacterials, Antibiotics are produced naturally.Find antibiotics suppliers and manufacturers that provides different types of antibiotics with reasonable prices.

What are the sub-categories of Antibiotics?
On PharmaSources.com, diverse Antibiotics is available under these sub-categories:

ChloramphenicolsTetracyclinePenicillinCephalosporinsMacrolidesLincomycinAminoglycosideOther Antibiotics
Who is supplying the Antibiotics products?
Among the 8,000+ pharmaceutical suppliers on PharmaSources.com, the following are the popular Antibiotics suppliers who specialized in providing quality Water Purification Equipments:

JIANGSU PROVINCE QINFEN PHARMACEUTICAL CO.,LTDHunan Kerey Pharmaceutical Co., Ltd.Shandong Kexing Bioproducts Co.,LtdQILU PHARMACEUTICALCSPC PHARMA.
Where are the major sales markets?
The Antibiotics on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

As one of antibiotics manufacturers and antibiotics suppliers, we can offer kinds of related products for sale, if you have needs, please contact us.

Anesthetics Products(2022年11月11日)

pharmasources — 2022-11-10T10:19:46+0900

https://www.pharmasources.com/products/catid/anesthetics-21.html

Anesthetic refers to drugs used to induce anesthesia, which results in a temporary loss of sensation or awareness. There are two main types of anesthesia drugs: general anesthetics and local anesthetics. General anesthetics can produce a reversible loss of and sensation and consciousness for the whole body, meanwhile, local anesthetics can produce a reversible loss of sensation for a limited region of the body without necessarily affecting consciousness.

Where are the major sales markets?
The Anesthetics on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Active Pharmaceutical Ingredients Products(2022年11月10日)

pharmasources — 2022-11-10T10:18:53+0900

https://www.pharmasources.com/products/catid/active-pharmaceutical-ingredients-4.html

Active pharma ingredients or API is a substance used in a finished pharmaceutical product (FPP); API ingredient is different from an inactive ingredient (excipient) in that it is intended to furnish pharmacological activity. Namely, it is the constituent that will have the desired pharmaceutical action or effect when administered. The active pharma ingredients can be prepared by chemical synthesis, plant extraction, or biotechnology. The API pharmaceutical industry is the main pillar of the pharmaceutical industry. Countries all over the world have established strict standards for APIs to control the quality.

What are the sub-categories of Active Pharmaceutical Ingredients?
On PharmaSources.com, diverse api active pharmaceutical ingredient is available under these sub-categories:

VitaminAlkaloidsAntibioticsHormonesSulfonamidesPhospholipidsRespiratory System DrugsAntipyretic AnalgesicDigestive System DrugsCardiovascular System DrugsCentral Nervous System DrugsAnestheticsOther Anti-Infective DrugAntiparasiticProstaglandinsOther Active Pharmaceutical IngredientsBiochemical Ingredients

Who is supplying the Active Pharmaceutical Ingredients products?
Among the 8,000+ pharmaceutical api manufacturers on PharmaSources.com, the following are the popular Active Pharmaceutical Ingredients suppliers who specialized in providing quality Water Purification Equipments:

Shandong Jiulong Hisince Pharmaceutical Co., Ltd.ANHUI JINQUAN BIOLOGICAL TECHNOLOGY CO.,LTD.Lianyungang Jari Pharmaceutical Co., Ltd.ANHUI LIXING CHEMICAL CO., LTD.Shanghai RC Chemicals Co.,Ltd
Where are the major sales markets?
The active pharmaceutical ingredients list on PharmaSources.com are supplying all around the world, including the markets in North America, Central/South America, Western Europe, Eastern Europe, Australasia, Asia, Middle East and Africa.

Lutz Hilbrich Appointed as Senator to the Senate of Economy Europe(2022年10月21日)

pharmasources — 2022-10-08T16:47:25+0900

https://www.pharmasources.com/products/searchKey-therapy

MiGenTra and ProBioGen announce the appointment of Dr. Lutz Hilbrich, Chief Executive Officer of both companies, as Senator to the Senate of Economy Europe. The certificate of appointment was presented to Dr. Hilbrich in Strasbourg, France, today.

The Senate of Economy Europe is a Think & Do Tank. Members include representatives from business, science and society, engaged in dialogue with decision-makers from politics, business, culture and the media. The aim of the Senate is to revive the traditional idea of the senators of the antiquity on a European level: a balanced circle of independent spirit favoring the common good over self-interests. Honorary Senators like Jean Claude Juncker, Sigmar Gabriel, Klaus Töpfer, Rosi Gollmann, and in the past Hans-Dietrich Genscher, reflect the idea of what defines the Senate.

Dr. Hilbrich says: "I am truly honored by the appointment as Senator. The Senate offers the interaction on an international level with a diverse array of game changing individuals. I am particularly committed to support and drive in the Senate of Economy Europe further the idea of the Marshall Plan with Africa, where MiGenTra can play a ground-breaking role."

About ProBioGen
ProBioGen is a specialist in the development and manufacturing of complex therapeutic proteins.

The combination of ProBioGen's CHO.RiGHT® expression platform and state-of-the-art process development platforms, together with intelligent and innovative product-specific technologies yield biologics with optimized properties.

Rapid and integrated cell line and process development, comprehensive analytical development and robust GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).

ProBioGen has been operational for more than 25 years. At two locations in Berlin, more than 200 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work.

About MiGenTra
MiGenTra was founded in 2021 by ProBioGen and Minapharm Pharmaceuticals for the development and commercialization of high quality affordable biologic medicines in the field of Biosimilars, Cell- and Gene Therapies (CGT) and Vaccines to serve the needs of patients across Africa and the Middle East. MiGenTra is leveraging the strong development and manufacturing capabilities of parent companies ProBioGen and Minapharm as well as on the excellent market position of Minapharm in the region.

About Minapharm Group
The Minapharm group led by Chairman and CEO Dr. Wafik Bardissi comprises currently 4 companies, two of which are headquartered in Cairo, Egypt: Minapharm Pharmaceuticals and MiGenTra Egypt, and two with Headquarters in Berlin, Germany: ProBioGen and MiGenTra.

Oculis Strengthens Leading Ophthalmology Pipeline by In-Licensing Neuroprotective Drug Candidate for Glaucoma from Accure Therapeutics(2022年10月20日)

pharmasources — 2022-10-08T16:45:26+0900

https://www.pharmasources.com/news/63096.html

- First-in-class peptidomimetic with distinct MoA activating trophic signaling pathways to protect and prevent damage to the optic nerve and retina
- Potential to be disease modifying in lead indications such as glaucoma, geographic atrophy, acute optic neuritis (AON) and other optic neuropathies
- Proof of concept (PoC) clinical trial in progress for AON with results due 2H23
- Agreement supports Oculis's mission to become a global ophthalmology leader bringing breakthrough innovations to the top three segments of the market: retina, dry eye and glaucoma
- Deal validates Accure's strategy as a translational R&D engine in neuroscience

Oculis S.A., (Oculis) a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, and Accure Therapeutics, a private translational neuroscience R&D company, today announced a licensing agreement granting Oculis exclusive global rights to develop and commercialize ACT-01, a potentially disease-modifying therapy to protect and prevent damage to the optic nerve and retina.
ACT-01, which is being renamed OCS-05, is a first-in-class small molecule with neuroprotective activity that has shown positive results in animal models of neuroinflammation and neurodegeneration. Its mechanism of action is related to the activation of the trophic factor pathways such as IGF-1 and BDNF. In ophthalmology, this action can protect the nerve axons in conditions where the optic nerve is affected, such as in acute optic neuritis and glaucoma, where the OCS-05 could prevent chronic vision loss.
Based on positive preclinical data and results of a phase 1 safety and PK study in healthy volunteers, a phase 2a study was initiated (the ACUITY study).
ACUITY is a two-arm, randomized, double-blind, placebo-controlled, monocentric study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis. In addition to safety, secondary outcome measures will include optic nerve anatomical measures, as well as visual function measures. The study is ongoing at the La Pitie-Salpetriere hospital in Paris within the neurology-ophthalmology network of the Public University Hospital Group in Paris (APHP). One third of the planned sample size has been enrolled.
Oculis is currently planning the expansion of the program in ophthalmology working with the regulatory agencies in the US, EU and China amongst others.
Riad Sherif, M.D., CEO of Oculis, said: "We are excited about this agreement as it combines Oculis's ophthalmology expertise with Accure's unique neuroprotective approach to help transform the treatment of neurodegenerative diseases in ophthalmology. At Oculis, our focus is on building a highly innovative and differentiated pipeline providing life changing treatments for ocular unmet medical needs, and OCS-05 is a perfect fit for that ambition. Glaucoma is a leading global cause of irreversible blindness, and despite IOP lowering treatments, a significant proportion of patients still go blind. With OCS-05, we have the potential to bring to market the first neuroprotective for glaucoma and other optic neuropathies."
Laurent Nguyen, M.D., Co-founder and Chief Executive Officer at Accure Therapeutics, said: "Having shown promising early data and potential in a number of ocular disease indications, the timing is right for a partnership between two like-minded companies committed to patients and driven by a passion for neuroscience. By leveraging its expertise in ophthalmology, Oculis has the potential to fulfill the promise of this exciting asset in a wide range of neurodegenerative diseases."
In reference experimental animal models of acute optic neuritis (acute inflammatory demyelinating disorder of the optic nerve) and high-pressure glaucoma (high eye pressure damaging the optic nerve and leading to permanent vision loss), OCS-05 reduces damage to the optic nerve and retina. It also decreases paralysis progression in an autoimmune encephalomyelitis animal model for multiple sclerosis (inflammation caused by the body's immune system, which destroys nerve cell processes and myelin in the brain and spinal cord).
Data from a completed phase 1 study show the safety and tolerability of single and multiple doses of OCS-05 in healthy volunteers.
Under the terms of the agreement, Accure Therapeutics will receive an upfront payment, potential milestone payments upon the achievement of certain development and commercial milestones, and tiered royalties on sales.
Anthony Rosenberg, Chairman of Oculis's Board of Directors, said: "The addition of OCS-05 to Oculis's pipeline is very much in line with the Company's strategy to develop transformative therapies that address the root cause of ocular disease to improve patients' sight and quality of life. There is a clear need for first-in-class therapies that can protect and prevent damage to the optic nerve and retina. Oculis has the team and expertise to bring OCS-05 through clinical trials and ultimately to patients around the world."
Montserrat Vendrell, Chairman of Accure Therapeutics and Partner at Alta Life Sciences added: "This licensing deal with Oculis is a proof-of-concept of the value creation that Accure Therapeutics brings as a translational R&D engine, taking forward truly unique science that spun-off from the University of Barcelona. This licensing agreement will enhance Accure's capabilities to accelerate and expand value potential for the rest of its pipeline."

About Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide.
Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

About Accure Therapeutics
Accure Therapeutics is a private translational neuroscience R&D company. Based in Barcelona (Spain), it was launched in 2020 with a Series A funding led by Alta Life Sciences Spain I and supported by the Centre for Technological and Industrial Development (CDTI). This European company with an international mindset boasts a unique portfolio of three new chemical entity programs pursuing innovative targets - with potential to accommodate others. Accure aims to develop new disease modifying drugs to treat serious conditions such as optic neuritis, multiple sclerosis, Parkinson's disease and epilepsy. With an experienced business and scientific team, Accure Therapeutics is one of the few companies that operate in an agnostic fashion on initial science to deliver cutting-edge drugs in CNS.

Altamira Therapeutics and Nuance Pharma Enter Into Exclusive Licensing and Distribution Agreement for Bentrio in China and Additional Asian Markets(2022年10月19日)

pharmasources — 2022-10-08T16:44:11+0900

https://www.pharmasources.com/products/searchKey-nasal spray

- Nuance Pharma to develop and commercialize Bentrio(TM) nasal spray in Chinese Mainland, Hong Kong, S.A.R., China, Macau, S.A.R., China and South Korea
- Altamira to receive up to $23.5 million in upfront and milestone payments during initial phase of supply Bentrio(TM) to Nuance
- Altamira to receive royalties on sales following start of local production of Bentrio(TM) by Nuance

Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics, announced today that it has entered into an exclusive licensing and distribution agreement (the "Agreement") for Bentrio(TM), its nasal spray for protection against airborne viruses and allergens, with Nuance Pharma Ltd. ("Nuance") in Chinese Mainland, Hong Kong, S.A.R., China, Macau, S.A.R., China and South Korea (the "Territory").
Under the terms of the Agreement, Altamira will initially supply Bentrio(TM) to Nuance. Nuance will make an upfront payment of $1 million and pay to Altamira development and commercial milestones of up to $3 million and up to $19.5 million, respectively. Nuance will have the right to register and commercialize Bentrio(TM) in the Territory. In a second stage, Nuance will assume local production of the product for the Territory upon certain milestones. Once Nuance assumes local production of Bentrio(TM), it will pay to Altamira a staggered royalty on net sales in the Territory at a high-single to low-double-digit percentage.
"We are excited to greatly expand the distribution of Bentrio and further enlarge our footprint in Asia through this strategic collaboration with Nuance," said Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "As a fast growing, well capitalized company with a growing portfolio of products specifically for the treatment of respiratory disorders, Nuance is an ideal commercialization partner for this important and dynamic region. We are looking forward to working with the Nuance team to launch Bentrio."
"The prevalence of allergic rhinitis in the Chinese Mainland is particularly high, affecting some 246 million patients[1]," commented Mark G. Lotter, CEO and Founder of Nuance. "In addition, viral infections represent another high-volume opportunity for Bentrio in this region, so we are looking forward to launching this promising therapeutic to patients in the Chinese Mainland; as well as Hong Kong, S.A.R., China, Macau, S.A.R., China and South Korea. Bentrio(TM) fits well with Nuance's continuous strategic focus in respiratory space."
References
[1]https://doi.org/10.4168/aair.2019.11.2.156

About Bentrio(TM)
Bentrio(TM)(AM-301) is a drug-free nasal spray intended for personal protection against airborne viruses and allergens. Upon application into the nose, Bentrio(TM) forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge and to humidify the nasal mucosa. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms. In human nasal epithelium cells infected by SARS-CoV-2, Bentrio(TM) was shown to reduce the infectious viral load by more than 99% when used for prevention. Further, Bentrio(TM) was effective in slowing the growth of the viral titer when treatment started only 24 or 30 hours after infection. In allergy, a clinical investigation in a pollen challenge chamber demonstrated a significant reduction in the main symptoms of allergic rhinitis with the protective effect setting in rapidly and lasting for 4 hours.

About Nuance Pharma
Nuance Pharma is a patient-centric and innovation focused biopharmaceutical company, with both clinical and commercial stage assets. Founded by Mark Lotter in 2014, with the mission to address critical unmet medical needs in Greater China and Asia Pacific, Nuance has built a late clinical stage innovative portfolio, while maintaining a self-sustainable commercial operation. Focusing on specialty care, Nuance's portfolio represents a differentiated combination of commercial stage and innovative pipeline assets across respiratory, emergency care, and iron deficiency anemia. Through partnerships with global leading biopharma companies, Nuance has built a leading late-stage portfolio in respiratory and commercial stage portfolio in emergency care and iron deficiency anemia.

About Altamira Therapeutics
Altamira Therapeutics is dedicated to developing therapeutics that address important unmet medical needs. The Company is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets (OligoPhore(TM) / SemaPhore(TM) platforms; preclinical), nasal sprays for protection against airborne viruses and allergens (Bentrio(TM); commercial) or the treatment of vertigo (AM-125; Phase 2), and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss (Keyzilen(R) and Sonsuvi(R), Phase 3). The Company was founded in 2003 and is headquartered in Hamilton, Bermuda with its main operations in Basel, Switzerland. The shares of Altamira Therapeutics Ltd. trade on the NASDAQ Capital Market under the symbol "CYTO."

Forward-looking Statements
This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira Therapeutics' strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may", "might", "will", "should", "expects", "plans", "anticipates", "believes", "estimates", "predicts", "projects", "potential", "outlook" or "continue", or the negative of these terms or other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the approval, timing of commercialization and commercial success of AM-301, Altamira Therapeutics' need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Altamira Therapeutics' product candidates, the clinical utility of Altamira Therapeutics' product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics' intellectual property position and Altamira Therapeutics' financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics' capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Altamira Therapeutics' Annual Report on Form 20-F for the year ended December 31, 2020, and in Altamira Therapeutics' other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and Altamira Therapeutics does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law.
SOURCE: Altamira Therapeutics Ltd.

Eisai to Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State (DSE) Symposium, and Other Pipeline Assets at the AD/PD 2022 Annual Meeting(2022年10月18日)

pharmasources — 2022-10-08T16:41:35+0900

https://www.pharmasources.com/news/71910.html

Eisai Co., Ltd. announced today the company will present research from its robust Alzheimer's disease (AD) pipeline, including the latest findings on lecanemab, Eisai's investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early AD at the AD/PD 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) from March 15-20 in Barcelona, Spain and virtually.
The lecanemab data and additional research findings from Eisai's clinical development programs will be featured in 13 presentations. Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the first quarter of Eisai's fiscal year 2022, which begins April 1, 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022.
"Four key presentations at AD/PD 2022 advance our understanding of the mechanism of action of Eisai's investigational anti- Abeta protofibril antibody lecanemab and the therapy's clinical and safety profile, including amyloid related imaging abnormalities, or ARIA, from the Phase 2b study and open-label extension, in the potential treatment of early Alzheimer's disease," said Michael Irizarry, M.D., Senior Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "In addition to lecanemab, Eisai's robust pipeline includes compounds targeting the tau pathway, other pathways leading to neurodegeneration, and the testing of combination therapies that may be the optimal approach to treat or even prevent Alzheimer's disease."
The focus on AD has historically been on alleviating cognitive, functional, and behavioral symptoms, but there has been significant progress in understanding the biological mechanisms of the disease. Eisai's investigational pipeline aims to treat the range of underlying pathophysiology, including amyloid, tau and neurodegeneration.
"Because of the robust design of the lecanemab Phase 2b study, Eisai was able to design the Phase 3 confirmatory Clarity AD clinical trial to optimally verify lecanemab's clinical efficacy and safety in early Alzheimer's disease," said Ivan Cheung, Chairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd. "Part of the recruitment strategy for the Clarity AD confirmatory trial was to ensure greater inclusion of ethnic and racial populations. While there is still important work to be done in ensuring minority populations' participation in clinical trials, Eisai is proud that approximately 25% of the total U.S. enrollment in Clarity AD consists of African American and Hispanic persons living with early Alzheimer's disease, which mirrors the U.S. Medicare population."
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.

InnoCare Announces Acceptance of Supplemental New Drug Application for Orelabrutinib in Relapsed or Refractory Waldenström’s Macroglobulinemia in China(2022年10月17日)

pharmasources — 2022-10-08T16:40:04+0900

https://www.pharmasources.com/products/catid/medical-supplies-3001.html

InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced recently that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia (R/R WM).

"According to the evaluation of the Independent Review Committee (IRC) and the principal investigators, the treatment of R/R WM patients with orelabrutinib at a dose of 150mg once a day reached the primary end point, showing encouraging efficacy, which is expected to improve with the extension of treatment time,” said Professor Daobin Zhou, Director of Hematology Department of Peking Union Medical College Hospital. “Meanwhile, orelabrutinib is well tolerated with safety profile in the treatment of WM patients. The incidence of adverse events, especially off-target related serious adverse events, is significantly lower in the clinical trial."

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, "WM poses a threat to patients' lives. We are encouraged that NMPA has accepted the supplemental New Drug Application for orelabrutinib in the treatment of R/R WM. This sNDA includes 47 patients from 16 clinical centers in China. We hope that orelabrutinib will bring a novel treatment option to R/R WM patients.”

On December 25, 2020, orelabrutinib received approval from NMPA in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).

About Waldenström’s Macroglobulinemia
Waldenström’s macroglobulinemia is a relatively slow-growing lymphoma characterized by the invasion of bone marrow by lymphoplasmacytic cells secreting monoclonal immunoglobulin M (IgM). The disease usually affects older adults and is primarily found in the bone marrow, although it may also impact lymph nodes and the spleen.

About Orelabrutinib
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25 2020, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.

Want to get more detailed information about Innocare Pharma and other kinds of medical surgical supply companies? Pharmasources could help you!

About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, China，New Jersey and Boston.

BioMed X Institute and Merck KGaA, Darmstadt, Germany, Start Second Research Project in Immunology(2022年10月16日)

pharmasources — 2022-10-08T16:38:54+0900

https://www.pharmasources.com/

With this project, the partners launch their eighth joint research program since 2013

A German independent research institute, BioMed X, announces today the start of its new research project ‘Regulatory T Cell Dysfunction in Autoimmunity and Inflammaging’ (TDA) in collaboration with Merck KGaA, Darmstadt, Germany. The main objective of the research group TDA is to understand the molecular mechanisms governing immune senescence and metabolic dysfunction in regulatory T cells and other T cell subsets that are shared in autoimmunity and aging.

Group Leader of team TDA, Dr. Gorjana Rackov, explains: “Regulatory T cells (Tregs) are crucial for maintaining self-tolerance and preventing autoimmune disease. During aging, cellular senescence of Tregs and their dysfunctional state may contribute to age-related diseases fueled by chronic inflammation in the elderly – also called “inflammaging”. Our goal is to improve patient outcomes by delivering new targets and novel therapeutic approaches for autoimmune disease treatment and for balancing immune responses in the elderly”, adds Rackov, who holds a PhD in molecular biology. Before joining the BioMed X Institute in Heidelberg, Rackov worked as a postdoctoral researcher at the National Centre for Biotechnology (CNB) in Madrid, which forms part of the Spanish National Research Council (CSIC).

The start of team TDA underlines the ongoing successful collaboration of the partners since the inception of the BioMed X Institute in Heidelberg, Germany, in 2013. With four research projects already successfully completed, team TDA will join the three ongoing research groups sponsored by Merck KGaA, Darmstadt, Germany: two in oncology (RNA Splicing in Cancer, Synthetic Lethality in DNA Repair) and one in immunology (Intestinal Epithelial Barrier in Autoimmune Diseases).

Christian Tidona, Founder and Managing Director of the BioMed X Institute: “The next big frontier in immunology research is understanding human disease biology in the context of human tissue microenvironment and at the level of single cells.” And Tidona adds: “This new project allows us to further deepen our expertise in immunology research and to lay the groundwork for new therapeutic concepts for the treatment of chronic inflammation in autoimmune patients and the elderly.”

Further details about this new research project can be found on Pharmasources.

About BioMed X
BioMed X is an independent research institute located on the campus of the University of Heidelberg in Germany, with a world-wide network of partner locations. Together with our partners, we identify big biomedical research challenges and provide creative solutions by combining global crowdsourcing with local incubation of the world’s brightest early-career research talents. Each of the highly diverse research teams at BioMed X has access to state-of-the-art research infrastructure and is continuously guided by experienced mentors from academia and industry. At BioMed X, we combine the best of two worlds – academia and industry – and enable breakthrough innovation by making biomedical research more efficient, more agile, and more fun.

FDA Approves First Generic of Symbicort to Treat Asthma and COPD(2022年10月15日)

pharmasources — 2022-10-08T16:36:36+0900

https://www.pharmasources.com/products/catid/medical-supplies-3001.html

Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research. “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”

Asthma impacts 25 million people, more than five million of whom are children, while COPD afflicts more than 16 million, according to the National Heart, Lung, and Blood Institute. Asthma is a chronic, long-term condition that affects the airways in the lungs, which can be worsened by physical activity and most often starts during childhood. It can cause wheezing (a whistling sound when breathing), shortness of breath, and coughing. COPD, which includes emphysema and chronic bronchitis, is a long-term, chronic disease that causes airflow blockage and makes it difficult to breathe.

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). Two inhalations, two times a day (usually morning and night, about 12 hours apart), treat both diseases by preventing symptoms, such as wheezing for those with asthma, and by helping with better breathing, for those with COPD. The inhaler is approved for two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation).

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis (swelling of nasal passages and back of throat), headache, upper respiratory tract infection, pharyngolaryngeal (nose and mouth) pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection.

The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device. To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts. In June 2015, FDA published a PSG for budesonide and formoterol fumarate dihydrate inhalation aerosol.

The FDA requires sponsors to submit appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency’s rigorous approval standards. These standards ensure that generic drug products are as safe and effective as their brand name equivalents and meet the same high quality standards. If you want to get more information about FDA and online medical supply companies, Pharmasources would be a great choice.

Complex products are medical products where uncertainty concerning the approval pathway or possible alternative approaches to product development can benefit from early scientific engagement, such as products with complex active ingredients and drug-device combination products. Since drug-device combination products can be more challenging to develop, fewer exist, resulting in less market competition. Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of the FDA’s Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.

The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, Inc.

Related Information

FDA: Generic Drugs

FDA: First Generic Drug Approvals

FDA: Drug Competition Action Plan

FDA: Product-Specific Guidances for Generic Drug Development

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Coriolis Pharma and U-Medico Announce a Strategic Alliance(2022年10月14日)

pharmasources — 2022-10-08T16:35:11+0900

https://www.pharmasources.com/products/catid/medical-supplies-3001.html

Coriolis Pharma and U-Medico Announce a Strategic Alliance.

Coriolis Pharma (Martinsried, Germany) and U-Medico (Osaka, Japan) will join forces to provide science-driven and innovative formulation development services for clients worldwide.

Coriolis Pharma, a globally operating service provider and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs located in Germany, and U-Medico, an innovative formulation development and biophysical characterizations service provider located in Japan, today announce a strategic alliance that includes an equity investment by Coriolis Pharma into U-Medico.

The alliance aims to extend Coriolis Pharma’s expertise, service portfolio and market reach into the Japanese and Asian market, while strengthening U-Medico’s formulation development and biophysical characterization services, as well as expertise by giving integrated access to Coriolis Pharma’s service portfolio. Together, Coriolis Pharma and U-Medico will work on development projects for clients and enable innovative therapies by revolutionizing formulation development and biophysical characterizations of biopharmaceuticals and ATMPs, such as viral vectors, and gene- and cell therapies for clients worldwide.

In addition, researchers from both companies will exchange scientific knowledge and work together in scientific collaborations, to generate know-how and publications in the field of formulation development and characterization of biopharmaceuticals and gene- and cell therapy products.

“U-medico is the leading provider of science-driven formulation development and biophysical characterization services in Japan and we as Coriolis are proud to become part of it. The strategic alliance is the next step for Coriolis Pharma growths strategy based on excellent science.” said Dr. Michael Wiggenhorn, CEO of Coriolis Pharma.

Prof. Dr. Susumu Uchiyama, founder and Chief Scientific Officer of U-Medico, already joined the scientific advisory board of Coriolis Pharma in September 2021. Prof. Dr. Uchiyama is also leading the Japanse national project consortium for the development of characterization and quality control of virus vectors for gene therapy.

“This strategic alliance strengthens the scientific collaboration between Coriolis and U-Medico. We are excited to grow together and support our clients with more specialized and high-quality formulation development services,” pointed out by Dr. Ayano Fukuhara, CEO of U-Medico.

“In-depth biophysical chemistry knowledge based on high-quality science is essential for the characterizations of biopharmaceuticals and virus vectors. This alliance will definitely contribute to the development of biopharmaceuticals and ATMPs with high quality and safety,” said Prof. Dr. Susumu Uchiyama.

About Coriolis Pharma
Coriolis Pharma is a globally operating service provider and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs including proteins, peptides, monoclonal antibodies, nucleic acids, virus-like particles, vaccines, advance therapy medicinal products (ATMPs) and genetically modified organisms (GMOs). Coriolis Pharma offers integrated development services for liquid and lyophilized formulations with all required technologies and analytical methods available in house. For each individual project, highly skilled scientists develop tailor-made study designs that align with the clients’ drug development strategy. With science-driven innovative solutions, Coriolis Pharma supports all phases of drug development including troubleshooting, batch-release testing including innovative methods and formulation optimization even beyond market approval. Our mission is: formulating innovation! If you want to get detailed information on Coriolis Pharma and other healthcare supply companies, Pharmasources would be your best choice.

About U-Medico
U-Medico Inc., a spin-out contract research organization of Osaka University, offers high-quality formulation development services and unique analytical services, e.g., analytical ultra-centrifugation (AUC) and hydrogen-deuterium exchange mass spectrometry (HDX-MS) for biopharmaceuticals including antibody and fusion proteins. U-Medico supports clients to produce safe and reliable biopharmaceuticals utilizing cutting-edge know-how and analytical technology. The company will establish a new unit for cell and gene therapy in April 2022 and intensively provide a high level of global standard analytical and quality testing services for gene therapy based on the expertise from Osaka University.

GMP certification for Exothera further extends its viral vector manufacturing capacity(2022年10月13日)

pharmasources — 2022-10-08T16:33:35+0900

https://www.pharmasources.com/products/catid/medical-supplies-3001.html

Exothera S.A., a CDMO specialized in the development and manufacture of viral vectors for vaccines and gene therapies, received Good Manufacturing Practices (GMP) certification from the Federal Agency for Medicines and Health Products (FAMHP) for its facilities in Jumet, Belgium. This accreditation follows a series of successful inspections ensuring that Exothera can manufacture biopharmaceutical products according to the highest quality standards. This will enable Exothera to extend its services to more customers, supporting biopharma companies from the early development of biotherapeutic candidate to full scale manufacture.

Exothera was founded in 2020 to help tackle two of the most critical challenges manufacturers face in bringing advanced therapies to market: a lack of production capacity and scarcity of bioprocessing expertise. Specific viral vector bioprocessing expertise is key to addressing the more complex manufacturing processes required for cell and gene therapy manufacture. These challenges have been keeping costs unnecessarily high and slowing the development and delivery of ground-breaking therapies from reaching those who need them most.

Initial operations began at two sites located in Nivelles and Gosselies while renovation and construction of new offices and large process development and production areas took place in two buildings on the Univercells campus in Jumet. These facilities now provide a combined area of 8,600 m² (92,570 ft²). Exothera together with Univercells’ team and selected partners has built one of Europe's largest state-of-the-art facilities with a GMP qualified manufacturing area totaling 2,100 m² (22,600 ft²) in just 18 months. The facility includes 5 upstream grade C clean rooms with several bioreactor technologies for adherent and suspension cell culture. The bioreactors can go up to 2 x 2,000L for the suspension platform and 2 x 600m² (2 x 6,450 ft²) for the adherence platform giving clients great flexibility and choice.

Exothera

In parallel, the company continued to expand its expert team recruiting candidates with extensive knowledge of viral vectors, like Hanna Lesch who joined as Chief Technology Officer in October 2021. Exothera currently has 140 experts who can work hand-in-hand with medical supplies manufacturers to rapidly develop and bring affordable treatments for patients to market.

Exothera has already worked on more than 28 projects for clients in the EU and US and has the space available to develop a further 9,000 m² (96,900 ft²) on the Jumet campus plus other greenfield options. The company is also considering options to grow internationally depending on client needs.

“This GMP accreditation for our facility extension is the cornerstone of everything we have been building since the beginning. We are extremely proud of the amazing work done by all the teams,” says Exothera’s CEO Thibault Jonckheere. “It will not only allow us to welcome new customers whose products are in early development stage but will also allow all of our existing partners to meet their large scale manufacturing needs”.

The addition of more manufacturing capacity is an important step to alleviate some of the current constraints in the industry. The pressure to develop and manufacture billions of vaccines, together with an expected 30+ new drug approvals by the FDA in the next year will put immense pressure on the global manufacturing capacity*. Exothera hopes to play a significant role in addressing some of these capacity needs by offering well-equipped facilities with the right technology and team that can rise to the challenge.

Exothera has demonstrated that it can accelerate the development of its own site, completing the build in record time. Its ambition is to create a new class of CDMO that will transform the time it takes customers to deliver their therapy so that life-changing therapies can be available to all patients who need them quickly.

Joint Research Shows that DENSO's Microalga, Coccomyxa sp. KJ Has Virucidal Effect against COVID-19(2022年10月12日)

pharmasources — 2022-10-08T16:32:12+0900

https://www.pharmasources.com/

Chubu University, Tokai University, Tohoku University School of Medicine and DENSO Corporation have found that monogalactosyl diacylglyceride (MGDG), a component contained in the chloroplasts of a microalga called Coccomyxa sp. KJ(1), has a virucidal effect(2) against COVID-19.

Coccomyxa sp. KJ is a fast-growing, vigorous, and easy-to-cultivate microalga. The plant contains not only abundant nutrients, including vitamins and amino acids, but also unique characteristics, such as suppressing an increase in the bacteria that cause periodontal disease. Moreover, in 2019, it was found that MGDG contained in Coccomyxa sp. KJ breaks the envelope membranes(3) of herpesviruses and has a virucidal effect against the viruses.
Recently, the three universities and DENSO discovered that MGDG contained in Coccomyxa sp. KJ also has a virucidal effect against COVID-19. The group will also research whether this microalga MGDG has a virucidal effect against influenza viruses, human coronaviruses, and other viruses with envelope membranes other than herpesviruses and COVID-19. Know more information about it on Pharmasources.
The results of the research may lead to the development of products that effectively counter COVID-19 and other viruses. The three universities and DENSO will continue to conduct this research to expand the scope of measures for preventing infectious diseases to contribute to society.
As an academia-industry collaboration project with the grant number JPMJTR204H, the research was conducted with support from the Adaptable and Seamless Technology Transfer Program through Target-driven R&D (A-STEP) funded by the Japan Science and Technology Agency (JST).
Glossary
(1) Coccomyxa sp. KJ is a registered trademark of DENSO Corporation. This microalga was developed by DENSO jointly with Kyoto University. "Stories," one of the DENSO-owned media, also features the plant: bit.ly/3JDGt38
(2) Virucidal effect means destroying the ability of viruses to infect cells.
(3) Envelope membranes are found in virus particles.

TANAKA Develops Gold Shell Nanoparticles That Can Be Prepared in High Concentrations Using High Dispersion Stability(2022年10月11日)

pharmasources — 2022-10-08T16:30:52+0900

https://www.pharmasources.com/products/catid/medical-supplies-3001.html

Achieving dispersion liquids with high concentrations that are 100 to 1,000 times that of existing products with expected applications in optical devices such as optical displays, optical sensing, and biosensors.

TANAKA Kikinzoku Kogyo K.K. (Head office: Chiyoda-ku, Tokyo; Representative Director & CEO: Koichiro Tanaka), which operates the TANAKA Precious Metals manufacturing business, announced today that TANAKA has developed gold shell nanoparticles1 that can be prepared in high concentrations using high dispersion stability.

This product is designed to cover the particle surface—such as that of silica—with an extremely thin gold shell that has a thickness of approximately 10 nm. It exhibits strong surface plasmon resonance2. Additionally, by using the high dispersion stability in water and polar solvents, it is possible to prepare dispersion liquids with high concentrations that are 100 to 1,000 times that of gold nanoparticles currently being sold on the market.

The overall size of gold shell nanoparticles can be controlled within a range of 80 nm to 250 nm, allowing them to be given a wide variety of optical characteristics. This is especially true for colloids with particle diameters several hundred nm prepared in high concentrations. They are easier to integrate or structure three-dimensionally, such as into colloid crystals, and can be expected to be applied to various optical materials.

Features of this product
■ Gold nanoshell with a thickness of 10 nm
The surface plasmon resonance exhibited by gold shell nanoparticles becomes more efficient in absorbing incident light, the thinner the shell. Compared to existing products on the market, this product achieves an extremely thin shell thickness of less than 10 nm. This allows the energy of incident light to be absorbed efficiently and also contributes toward dispersion stability as the relative mass of the overall particles becomes lighter.

■ Stable dispersion in water and organic solvents
Normally, gold nanoparticles with diameters of several hundred nm tend to autoagglutinate and precipitate as the particle concentration increases. This product can be dispersed stably in water and polar organic solvents, such as alcohol, as the particle surface is appropriately protected by a protective agent. Particles protected by the protective agent can be prepared with a weight ratio of 20% or higher, allowing use in processes that require highly-concentrated particle dispersion liquids. In addition, gold nanoshell dispersion liquids dispersed in organic solvents have excellent quick-drying properties and can also be coated on materials of various shapes.

■ Can produce SERS substrate by simply drying highly-concentrated gold nanoshell dispersion liquid
Surface-enhanced Raman scattering (SERS)3 exhibited by precious metal nanoparticles is particularly strong at the gaps between particles when precious metal nanoparticles are integrated. The locations where SERS is strongly manifested are called hotspots; being able to form hotspots with good reproducibility is important when producing SERS substrate. Traditionally, precious metal substrates with minute irregularities on the surface are used, but there were issues, such as low reproducibility.

This time, TANAKA Kikinzoku Kogyo has designed gold shell nanoparticles with surface plasmon resonance close to the wavelength of SERS excitation light, confirming that it is possible to produce SERS substrates with dense hotspots by simply drying highly-concentrated dispersion liquids.

Due to the aforementioned characteristics, this product can be expected to be used as an optical material that responds to light from visible to near-infrared regions, including colloid crystals, surface-enhanced Raman scattering, and photothermal conversion materials. Applications to optical devices are also expected, including optical displays and optical sensing that require high resolutions using liquid crystals, plasmonic nanoantennas, and biosensors, such as those used in cancer tests.

TANAKA Kikinzoku Kogyo plans to sequentially respond individually to requests for samples of this product. If you want to know more about this product, Pharmasources would be a great choice. Find more information about it and healthcare supply companies here!

1 Gold shell nanoparticle: This is a particle that forms a gold shell with a thickness in the order of nanometers on the surface of a core particle, which can be a colloid of inorganic materials, metals, or polymers. Various optical responses, different from pure gold nanoparticles, are exhibited depending on the shell thickness, core size, and core material.

2 Surface plasmon resonance: This is a phenomenon where the vibrations of free electrons in metals on the surface of metal nanoparticles resonate with incident light. The brilliant colors shown by gold shell nanoparticles are due to this phenomenon.

3 Surface-enhanced Raman scattering (SERS): When light is shone on a material, a wavelength different from the incident light is scattered by the material. This scattered light with a wavelength different from the incident light is called Raman scattered light, and every material exhibits its own unique Raman scattering spectrum. Therefore, it is possible to obtain information about the types of materials present by measuring the Raman scattering spectrum. However, to detect minute amounts of materials, it is necessary to enhance the Raman scattered light.

Surface-enhanced Raman scattering (SERS) is a phenomenon where the intensity of Raman scattered light is amplified when materials are absorbed at locations such as irregularities on surfaces of precious metals and in the gaps of precious metal colloids. As it is possible to detect even fewer molecules by designing precious metal surfaces that are suitable for enhancing Raman scattering, applications in fields such as drug detection and cancer diagnosis can be expected.

■About TANAKA Precious Metals
Since its foundation in 1885, TANAKA Precious Metals has built a portfolio of products to support a diversified range of business uses focused on precious metals. TANAKA is a leader in Japan regarding the volumes of precious metals handled. Over the course of many years, TANAKA has not only manufactured and sold precious metal products for industry but also provided precious metals in such forms as jewelry and assets. As precious metals specialists, all Group companies in Japan and around the world collaborate and cooperate on manufacturing, sales, and technology development to offer a range of products and services. With 5,193 employees, the group's consolidated net sales for the fiscal year ending March 31, 2021, was 1,425.6 billion yen.

Immunogenicity Information in Labeling(2022年10月10日)

pharmasources — 2022-10-08T16:28:50+0900

https://www.pharmasources.com/products/catid/medical-supplies-3001.html

This webinar has been approved for 1.5 contact hours of continuing education for pharmacists, physicians, and nurses. Please see detailed announcement for additional information.

ABOUT THIS WEBINAR
During this webinar, FDA will:

Highlight why immunogenicity is important to consider for drug development

Discuss the draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format (February 2022). When final, this guidance will represent FDA’s current thinking on this topic.

Discuss creation of the new dedicated subsection 12.6 for immunogenicity information (Immunogenicity subsection) in the CLINICAL PHARMACOLOGY section of labeling

Provide an overview on how to develop the Immunogenicity subsection

Describe when and how to incorporate immunogenicity information in other sections of labeling

Provide recommendations on when to update immunogenicity information in labeling

INTENDED AUDIENCE
Pharmaceutical industry staff who include immunogenicity information in labeling for their biological products [specifically human therapeutic protein products licensed under section 351(a) of the Public Health Service Act] and certain select drug products (regulated under section 505 of the Federal Food, Drug, and Cosmetic Act) with immunogenicity assessments (e.g., heparins, oligonucleotides, and peptides).

FDA SPEAKERS
Daphne Guinn, Ph.D.
Regulatory Health Project Manager
Office of Clinical Pharmacology (OCP)
Office of Translational Science (OTS) | CDER | FDA

Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER | FDA

FDA RESOURCES
Draft guidance for industry, Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format (February 2022). When final, this guidance will represent FDA’s current thinking on this topic.

Prescription Drug Labeling Resources

Immunogenicity development guidances:

Immunogenicity Assessment for Therapeutic Protein Products (August 2014)

Immunogenicity Testing of Therapeutic Proteins Developing and Validating Assays for Anti-drug Antibody Detection (January 2019)

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (April 2015)

Considerations in Demonstrating Interchangeability to a Reference Product (May 2019)

Immunogenicity-Related Considerations for Low Molecular Weight Heparin (February 2016)

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (May 2021)

Want to get more information about FDA resources and medical supply companies online? Pharmasources would be a great choice.

CONTINUING EDUCATION
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

approved for 1.5 contact hours of continuing education for pharmacists, physicians and nurses. Please see detailed announcement for more information.

pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.

pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.

pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.

approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION
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Please contact info@sbiaevents.com for all technical questions.

If you encounter any technical issues before or during the event, please visit the Technical Issues SupportExternal Link Disclaimer.

Test your PC for use with Adobe ConnectExternal Link Disclaimer prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.

Innovative AI Technology Aids Personalized Care for Diabetes Patients Needing Complex Drug Treatment(2022年10月09日)

pharmasources — 2022-10-08T16:27:42+0900

https://www.pharmasources.com/products/catid/medical-supplies-3001.html

Hitachi, Ltd. (TSE: 6501), University of Utah Health (U of U Health), and Regenstrief Institute, Inc. (Regenstrief) today announced the development of an AI method to improve care for patients with type 2 diabetes mellitus who need complex treatment. One in 10 adults worldwide have been diagnosed with type 2 diabetes, but a smaller number require multiple medications to control blood glucose levels and avoid serious complications, such as loss of vision and kidney disease.

For this smaller group of patients, physicians may have limited clinical decision-making experience or evidence-based guidance for choosing drug combinations. The solution is to expand the number of patients to support development of general principles to guide decision- making. Combining patient data from multiple healthcare institutions, however, requires deep expertise in artificial intelligence (AI) and wide-ranging experience in developing machine learning models using sensitive and complex healthcare data.
Hitachi, U of U Health, and Regenstrief researchers partnered to develop and test a new AI method that analyzed electronic health record data across Utah and Indiana and learned generalizable treatment patterns of type 2 diabetes patients with similar characteristics. Those patterns can now be used to help determine an optimal drug regimen for a specific patient.
Some of the results of this study are published in the peer-reviewed medical journal, Journal of Biomedical Informatics, in the article, "Predicting pharmacotherapeutic outcomes for type 2 diabetes: An evaluation of three approaches to leveraging electronic health record data from multiple sources".
Hitachi had been working with U of U Health for several years on development of a pharmacotherapy selection system for diabetes treatment(1) . However, the system was not always able to accurately predict more complex and less prevalent treatment patterns because it did not have enough data. In addition, it was not easy to use data from multiple facilities, as it was necessary to account for differences in patient disease states and therapeutic drugs prescribed among facilities and regions. To address these challenges, the project partnered with Regenstrief to enrich the data it was working with.
The new AI method initially groups patients with similar disease states and then analyzes their treatment patterns and clinical outcomes. It then matches the patient of interest to the disease state groups and predicts the range of potential outcomes for the patient depending on various treatment options. The researchers evaluated how well the method worked in predicting successful outcomes given drug regimens administered to patients with diabetes in Utah and Indiana. The algorithm was able to support medication selection for more than 83 percent of patients, even when two or more medications were used together.
In the future, the research team expects to help patients with diabetes who require complex treatment in checking the efficacy of various drug combinations and then, with their doctors, deciding on a treatment plan that is right for them. This will lead not only to better management of diabetes but increased patient engagement, compliance, and quality of life.
The three parties will continue to evaluate and improve the effectiveness of the new AI method and contribute to future patient care through further research in healthcare informatics.
Hitachi will accelerate efforts, including the practical application of this technology through collaboration between its healthcare and IT business divisions and R&D group. GlobalLogic Inc., a Hitachi Group Company and leader in Digital Engineering, is promoting healthcare- related projects in the U.S., will also deepen the collaboration in this field. Through these efforts, the entire Hitachi group will contribute to the health and safety of people.
(1) Hitachi, Ltd. news release, March 12, 2018 "Pharmacotherapy Selection System Supports Shared Clinician- patient Decision-Making in Diabetes Treatment"
Hitachi, Ltd. news release, February 27, 2019 "New Clinical Study Tests Pharmacotherapy Selection System that Aims to Improve the Impact of Diabetes Treatment"

About Hitachi, Ltd.
Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business. Hitachi is focused on strengthening its contribution to the Environment, the Resilience of business and social infrastructure as well as comprehensive programs to enhance Security & Safety. Hitachi resolves the issues faced by customers and society across six domains: IT, Energy, Mobility, Industry, Smart Life and Automotive Systems through its proprietary Lumada solutions. The company's consolidated revenues for fiscal year 2020 (ended March 31, 2021) totaled 8,729.1 billion yen ($78.6 billion), with 871 consolidated subsidiaries and approximately 350,000 employees worldwide. If you want to get more information about this company and medical supply distribution companies, then Pharmasources would be a great choice.

About University of Utah Health
University of Utah Health provides leading-edge and compassionate medicine for a referral area that encompasses 10% of the U.S., including Idaho, Wyoming, Montana and much of Nevada. A hub for health sciences research and education in the region, U of U Health has a
$428 million research enterprise and trains the majority of Utah's physicians, including more than 1,250 health care providers each year at its Schools of Medicine and Dentistry and Colleges of Nursing, Pharmacy and Health. With more than 20,000 employees, the system includes 12 community clinics and four hospitals. For ten straight years, U of U Health has ranked among the top 10 U.S. academic medical centers in the Vizient Quality and Accountability Study.

About Regenstrief Institute
Founded in 1969 in Indianapolis, the Regenstrief Institute is a local, national, and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.
Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institute's research mission.

InnoCare Announces Approval of Clinical Trial of TYK2 JH2 Allosteric Inhibitor ICP-488 in China(2022年10月08日)

pharmasources — 2022-10-08T16:25:33+0900

https://www.pharmasources.com/products/catid/bio-products-104.html

InnoCare Pharma (HKEX: 09969) announced today that the company has received Investigational New Drug (IND) approval of clinical trial from the NMPA (National Medical Products Administration) for its TYK2 JH2 allosteric inhibitor ICP-488, which is the Company's third innovative drug for the treatment of autoimmune diseases to enter the clinical stage.

ICP-488 is a potent and selective TYK2 (tyrosine kinase 2) allosteric inhibitor that, by binding the JH2 domain, blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokine, thereby inhibiting the pathological process of autoimmune and inflammatory diseases.

InnoCare discovered ICP-488 internally. As a novel oral TYK2 allosteric inhibitor, ICP-488 will be developed for the treatment of autoimmune diseases such as psoriasis and inflammatory bowel disease (IBD).

Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, “There is a large unmet clinical need for the treatment of autoimmune diseases worldwide. InnoCare has built a strong pipeline in autoimmune diseases. With the approval of ICP-488 for clinical trials, InnoCare will further strengthen its autoimmune disease pipeline and provide better treatment options for patients with autoimmune diseases worldwide.”

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Celonic to Become a Long-Term Partner of the Federal Republic of Germany for Vaccine Supply(2022年)

pharmasources — 2022-09-05T11:17:48+0900

https://www.pharmasources.com/products/searchKey-vaccine
https://www.pharmasources.com/products/catid/medical-supplies-3001.html

The Federal Republic of Germany has announced its decision to sign contracts with Celonic AG and four other partners to secure the long-term supply of vaccines in Germany against Covid-19 and other pandemics. Celonic will provide the capacity and the expertise for the production of protein-based vaccines at its Heidelberg site at least until 2029. If required, production of up to 80 million doses per year can begin immediately. Celonic will thus become an important part of pandemic preparedness in Germany.

Celonic runs state-of-the-art production facilities in Heidelberg for the clinical and commercial production of biological agents, mRNA and protein-based vaccines. Since 2020, a high double-digit million euro amount has been invested in the site. In the new 5000 m² production facility, 250 employees can produce up to 200 vaccine batches at a 2000L scale, which would be equivalent to up to 500 million vaccine doses. As part of the pandemic preparedness project, Celonic will prepare for a potential demand in the first phase and then have the capacity ready. For this purpose, a sustainable supply chain and a comprehensive staffing and production concept for preparedness will be established, along with an appropriate high-quality technology transfer process. This will enable Celonic to ensure local, safe, and rapid production of biopharmaceuticals in Germany in the future.

“It fills us with pride to be a significant part of the short and long-term fight against the pandemic in Germany," says Dr Konstantin Matentzoglu, CEO of the Celonic Group. “With investments in our state-of-the-art production site in Heidelberg, we have developed an outstanding technical set-up and personnel resources in recent years to provide safe, fast, and flexible production of biopharmaceuticals. In 40 years of GMP production of biopharmaceuticals, the Celonic Group has proven that it can deliver crucial and complex production projects reliably with high quality. We are therefore pleased that the Federal Republic has further bolstered the trust shown by our customers in Celonic.”

With an eye to the future, in addition to production in Heidelberg, the company is expanding with the Rheintal Life Science Park in Stein, Switzerland. On the site, Celonic is pushing ahead with the construction of one of the largest centres for cell and gene therapy in Europe. The 8500 m² facility will house production capacities for advanced therapies such as mRNA, viral vectors, human cells and extracellular vesicles. There, the next generation of vaccines and therapeutics will be produced starting 2023. Want to know more about vaccines and medical hospital supplies? Pharmasources would be a great choice.

About the Vaccine Production Task Force of the Federal Republic of Germany

The Vaccine Production Task Force responsible for the pandemic preparedness contracts was established by the Federal Ministry for Economic Affairs and Climate Action in 2021 and has negotiated the contracts with five selected partners. Further administration and management are carried out by the Centre for Pandemic Vaccines and Therapeutics at the Paul Ehrlich Institute (ZEPAI) under the purview of the Federal Ministry of Health. The next step is to sign the pandemic preparedness contracts. Immediately afterwards, Celonic will begin the measures to prepare for the implementation of pandemic preparedness.

About Celonic
Celonic is a premium CDMO (contract development & manufacturing organisation) for process development and production of innovative biopharmaceuticals such as biologics, mRNA and cell and gene therapy products. The company is part of the family-owned J.Rettenmaier & Söhne (JRS Group) and currently operates four production sites in Basel and Heidelberg. In 40 years of its corporate experience in GMP production, Celonic has continuously evolved from research projects to GMP production for clinical trials to commercial production of biologics and mRNA pharmaceuticals and is an internationally recognised production partner. In addition to the above-mentioned production site for biologics in Heidelberg, the other sites in Basel are engaged in the development and clinical production of next-generation therapeutics such as mRNA, viral vectors, cell therapies and extracellular vesicles. Celonic plans to manufacture these next-generation therapeutics in a state-of-the-art commercial facility near Basel.

Rentschler Biopharma and Vetter Unveil Xpert Alliance, a Joint Visualization of their Successful Strategic Collaboration(2022年)

pharmasources — 2022-09-05T11:17:15+0900

https://www.pharmasources.com/news/74811.html

Rentschler Biopharma and Vetter, two globally operating Contract Development and Manufacturing Organizations (CDMOs), announced today that the companies are unveiling Xpert Alliance, a joint visualization of their strategic collaboration. The visualization is designed to “bring to life” this ongoing alliance and celebrate its successful operation, delivering effective solutions to address clients’ changing and expanding needs in the area of complex biopharmaceuticals.

In mid-2020, Vetter and Rentschler Biopharma entered this strategic alliance intended to create long-term value that enables clients to bring their complex products to patients more easily and faster, through the coordination of their respective manufacturing services. By offering complementary skills and experience along the biopharmaceutical value chain, together, the two CDMOs have mutually enhanced their services, evidenced by the strong progress in their ongoing initial joint client projects. Since that time, the two independent companies have worked closely together to advance this important alliance. Today’s announcement marks an important step in heightening the visibility of the collaborative services to clients, as the strategic alliance matures.

“It is exciting to see how our alliance has been steadily evolving and taking shape,” stated Dr. Frank Mathias, CEO of Rentschler Biopharma. “We and Vetter have ambitious goals for our collaboration and believe that our clients can greatly benefit from the complementary services and seamless interactions we offer, with the ultimate aim of bringing new, life-changing treatment options to patients.”

Vetter Managing Director Peter Soelkner agreed: “With joint projects ongoing, the day-to-day workings of our strategic alliance are running smoothly, as we work together to create best-in-class solutions for our clients from early development stage through to the market. We are pleased with the progress we have made so far and look forward to demonstrating the added value we are generating through our collaboration.”

Xpert Alliance, the name of the joint visualization introduced today, clearly indicates what this strategic collaboration of two leading CDMOs can offer, and the tagline – from substance to product to patient – outlines the breadth of the offering. The coming together of Rentschler Biopharma and Vetter is visually represented by the two shades of blue in the X – each of the company’s corporate colors. At the same time, the companies retain their individuality, as shown by the two names as part of the joint logo.

Xpert Alliance embodies the true essence of this important collaboration, and the visualization marks another milestone in this strong and growing partnership.

About Rentschler Biopharma SE
Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. In order to offer best-in-class formulation development along the biopharmaceutical value chain, the company has entered into a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned company with about 1,100 employees, headquartered in Laupheim, Germany, with a second site in Milford, MA, USA. In Stevenage, UK, Rentschler Biopharma has launched a company dedicated to cell and gene therapies, Rentschler ATMP Ltd.

Follow Rentschler Biopharma on LinkedIn and Facebook.

About Vetter
Headquartered in Ravensburg, Germany, Vetter is a global leading contract development and manufacturing organization (CDMO) with production facilities in Germany, Austria and the United States. Currently employing 5,700 individuals worldwide, the company has long-term experience in supporting biotechnology and pharmaceutical customers both large and small. Vetter services range from early stage development support including clinical manufacturing, to commercial supply and numerous packaging solutions for vials, syringes and cartridges. As a leading solution provider, Vetter appreciates its responsibility to support the needs of its customers by developing devices that contribute to increased patient safety, convenience, and enhanced compliance. Great importance is also given to social responsibility including environmental protection and sustainability.

InnoCare Announces Dosing of First Patient in Clinical Trial of RTK Inhibitor ICP-033 in China(2022年)

pharmasources — 2022-09-05T11:16:46+0900

https://www.pharmasources.com/products/catid/protein-antigen-polypeptide-107.html

InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases,announced today that the first patient has been dosed in clinical trial of the Company’s novel RTK (Receptor Tyrosine Kinase) ICP-033 in China.

ICP-033 is a multi-kinase inhibitor mainly targeting discoid in domain receptor 1 (DDR1) and vascular endothelial growth factor receptor (VEGFR) that inhibits angiogenesis and tumor cell invasion, normalizes abnormal blood vessels, and reverses the immunosuppressive state of the tumor microenvironment. Pre-clinical studies have shown that ICP-033 exhibits strong antitumor effects both in vivo and in vitro. ICP-033 will be potentially used as monotherapy and/or in combination with immunotherapy and other targeted drugs to treat liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said, “We feel encouraging to see the clinical progress of another new drug candidate for the treatment of solid tumors. ICP-033 will further strengthen our pipeline in solid tumors. We will advance the clinical development to provide a competitive treatment solution for the treatment of solid tumors.”

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FDA Inspections of Outsourcing Facilities(2022年)

pharmasources — 2022-09-05T11:16:17+0900

https://www.pharmasources.com/news/going-global-successfully!-bcma-car-t-of-75805.html

ABOUT THIS WEBINAR
During this webinar, FDA will:

Provide an overview of the inspection process for compounding outsourcing facilities.

Discuss what to expect during an inspection, from initiation to closeout as well as observations on successes and challenges.

INTENDED AUDIENCE
Compounding outsourcing facilities

Compounding pharmacies with interest in the outsourcing facility sector and FDA compounding inspections

State pharmacy regulators

Consultants focused on outsourcing facilities and compounding pharmacies

FDA-regulated industry or general public with an interest in the inspections process for compounding pharmacies and outsourcing facilities

TOPICS COVERED
Current Good Manufacturing Practices (CGMPs) for Outsourcing Facilities

Insanitary conditions

Initial facility walk-through

Aseptic operators and operations

Process and facility design

Cross contamination

Environmental and personnel monitoring

Product inspection and component control

Packaging and labeling control

Records review

Evaluation of compliance with section 503B of the FD&C Act

FDA SPEAKERS
Jessica Pressley McAlister
Pharmacy Compounding National Expert
Division of Pharmaceutical Quality Programs (DPQP)
Office of Pharmaceutical Quality Operations (OPQO)
Office of Regulatory Affairs (ORA) | FDA

Lori Cantin, PharmD, MS, RPh
Captain, U.S. Public Health Service
Branch Chief, Branch 3
Division of Compounding II
Office of Compounding Quality & Compliance (OCQC)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | FDA

FDA RESOURCES
Regulatory Policy Information | FDA

Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice

Human Drug Compounding

Compounding Quality Center of Excellence | Training Programs

This course has been:

pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.

pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.

approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION
To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.

Please contact info@sbiaevents.com for all technical questions.

If you encounter any technical issues before or during the event, please visit the Technical Issues SupportExternal Link Disclaimer.

Rokote Laboratories selects Exothera for GMP manufacturing of its second-generation coronavirus vaccine FINCoVac 2.0.(2022年)

pharmasources — 2022-09-05T11:15:37+0900

https://www.pharmasources.com/products/catid/protein-antigen-polypeptide-107.html

Rokote Laboratories Finland Ltd., a vaccine development company focusing on a second-generation COVID-19 vaccine, and Exothera S.A. will collaborate to bring the intranasal coronavirus vaccine FINCoVac 2.0 to clinical Phase I/II trials. Exothera will finetune the industrialization of the FINCOVAC 2.0 process and manufacture clinical material for Phase I/II trials.

FINCoVac 2.0 is designed to address the most critical current coronavirus variants and it is based on adenoviral vector gene transfer technology. The FINCoVac vaccine is designed to program the nasopharyngeal cells to produce an immune response-inducing modified SARS-CoV-2-viral spike protein. FINCoVac 2.0 represents an easy-to-administer booster for those who are already fully vaccinated with other coronavirus vaccines.

Rokote Laboratories Finland Ltd.Exothera

Exothera is a leading CDMO specializing in the industrialization of vaccine and gene therapy processes with deep knowledge of modern scalable bioreactors, downstream process technologies and GMP manufacturing. Exothera offers a full-service model where it manages all the elements of the product development value chain, from process development to manufacturing. This single partner approach will allow Rokote Laboratories to enter clinical trials more quickly.

Rokote Laboratories selects Exothera for GMP manufacturing of its second-generation coronavirus vaccine FINCoVac 2.0.

Hanna Lesch, Chief Technology Officer at Exothera: “Exothera’s leading viral manufacturing expertise fits perfectly with Rokote Laboratories’ needs. As a Finn, I am proud to be part of the Finnish FINCoVac vaccine program. We are excited to continue supporting the ongoing fight against the coronavirus pandemic.”

Erkko Ylösmäki, Director, Research and Development at Rokote Laboratories Finland: ”Exothera’s manufacturing capabilities, the full-service model, and the outstanding commitment to rapid manufacturing of our vaccine for the Phase I/II trials is everything we were looking for from a CDMO. We are excited to start this collaboration to address the global need for an easy-to-administer COVID-19 vaccine that can not only prevent the disease but can also prevent those vaccinated from further transmitting the SARS-CoV-2 virus.”

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ReiThera and Exothera Collaborate to Develop Large-scale, Low Cost per Dose Manufacturing Process to Deliver Novel Vaccines to Low- and Middle-Income Countries(2022年)

pharmasources — 2022-09-05T11:15:10+0900

https://www.pharmasources.com/products/catid/bio-products-104.html

Collaboration awarded €3 million grant by the Bill & Melinda Gates Foundation

Focus on developing a scale-up manufacturing process for the production of ReiThera’s vaccine candidates based on its GRAd platform, including its COVID-19 vaccine candidate (GRAd-COV2)

Scale-up development will use Univercells Technologies’ NevoLine™ Upstream platform, which provides automated large-scale virus manufacturing in a compact footprint

ROME, Italy and JUMET, Belgium, April 12th, 2022 – ReiThera Srl, a bio pharmaceuticals company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies, and Exothera, a full-service Contract Development and Manufacturing Organization (CDMO), announced today that they have entered into a collaboration agreement to develop a large-scale, low cost per dose manufacturing process for the production of ReiThera’s novel vaccines.

The collaboration will be financed by a €3 million grant awarded by the Bill & Melinda Gates Foundation to develop and deliver new low-cost vaccines based on ReiThera’s GRAd technology platform, including against COVID-19 and HIV, mostly for Low- and Middle-Income countries (LMIC) in Africa. Immunization remains one of the most impactful and cost-effective public health interventions in Low and Middle-Income countries who are still struggling to secure access to adequate supplies.

The scale-up manufacturing process will leverage Exothera’s unique expertise using the NevoLine™ Upstream platform (integrating the intensified structured fixed-bed scale-X™ nitro bioreactor), developed by Exothera’s sister company, Univercells Technologies. This innovative biomanufacturing technology has a highly compact footprint while delivering unmatched cost-effective vaccine production.

Under the terms of the agreement, Exothera will scale up the proprietary cell line into the NevoLine and infect them with GRAd vector to create the bulk vaccine product, which ReiThera will then purify. The viral bulk generated after the infection will be purified by a high performing process developed by ReiThera.

ReiThera will start with its GRAd vector currently used in its COVID-19 vaccine candidate (GRAd-COV2) for the initial process development set-up and transition it into final form for further clinical trial purposes in its state-of-the-art GMP manufacturing facility.

Stefano Colloca, ReiThera’s Chief Technology Officer and co-Founder, commented, “This collaboration with Exothera is an important step in providing ReiThera’s novel vaccines for further study in a range of serious diseases, and in particular for seeking a solution that makes these vaccines more readily available once approved to people in LMIC regions. This second Bill & Melinda Gates Foundation grant, following an initial grant to ReiThera in November 2021 to support the development of the GRAd platform, provides further validation of ReiThera’s innovative technology and underscores our technical expertise in clinical manufacturing and bio-risk management.”

“ReiThera’s innovative GRAd platform technology paired with Exothera’s process development and scaling-up know-how has the potential to make important vaccines available for all,” said José Castillo, Exothera’s Chairman. “Combining our process know-how with Univercells Technologies’ Nevoline will provide Low- and Middle-Income countries with access to much needed solutions for unmet medical needs such as HIV as well as against the current global pandemic.”

Avantor Announces Investment in Manufacturing and Distribution Hub in Singapore to Serve Rapidly Growing Asia Pacific Biopharma Industry(2022年)

pharmasources — 2022-09-05T11:14:35+0900

https://www.pharmasources.com/products/catid/bio-products-104.html

Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, announced on May.5th that it will create a new manufacturing and distribution Hub in Singapore, by integrating its existing distribution facility with new manufacturing operations. The new Hub, which brings Avantor solutions closer to regional customers and strengthens global supply chain capabilities, will be fully operational early next year.

"The Singapore Manufacturing and Distribution Hub will enable Avantor to better serve the fast-growing Asia Pacific Biopharma market by facilitating shorter lead times, enhancing supply chain security and increasing capacity in the region," said Christophe Couturier, Executive Vice President, AMEA, Avantor. "The Hub will boost regional innovation and serve as an industry benchmark for Singapore and Asia Pacific's global quality and regulatory standards, and demonstrates Avantor's commitment to growing our presence in the region."
The new Hub will provide a range of services including quality control and inventory management expertise, and feature cGMP manufacturing suites and testing labs for process ingredients and excipients.

About Avantor
Avantor, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.

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Latest Data of InnoCare’s Robust Oncology Pipelines Presented at the 2022 ASCO Annual Meeting(2022年)

pharmasources — 2022-09-05T11:12:56+0900

https://www.pharmasources.com/products/catid/bio-products-104.html

Poster Presentation 1:

Phase I results of gunagratinib (ICP-192), a highly selective irreversible FGFR 1-4 inhibitor in patients with head and neck cancer (HNC) harboring FGF/FGFR gene aberrations

Abstract Number: 6039

In the dose-escalation study, patients with advanced solid tumors (including HNC) with or without FGF/FGFR gene alterations were treated with escalating doses (range: 2mg-26mg) of gunagratinib once daily in 21-day cycles.

12 HNC patients were treated with escalating doses (range: 14mg-22mg) of gunagratinib. Among the 9 HNC patients with FGF/FGFR gene aberrations including FGF amplification and FGFR mutation, who have completed at least one tumor assessment, the overall response rate (ORR) was 33.3%, and the disease control rate (DCR) was 66.7%. The treatment-related adverse events (TRAEs) were manageable and gunagratinib was generally safe and well tolerated.

The most common treatment-related adverse events (TRAEs) included hyperphosphatemia, diarrhea, increased ALT or AST, etc. No serious TRAE were reported in HNC patients.

According to RECIST 1.1 criteria, among the 6 patients with NTRK fusion, the overall response rate (ORR) was 66.7% (4 patients with partial response (PR)), the disease control rate (DCR) was 100%. The ORR was 100% in dose groups of 4mg and above. All patients who achieved PR responded to ICP-723 at the first tumor assessment after 4-week treatment and maintained sustained responses to the date of data cutoff. One patient with lung adenocarcinoma and brain metastasis achieved PR with the target brain lesion shrunk from 10 mm to 3 mm.

Dr. Xiaoli Wei from Sun Yat-sen University Cancer Center said, “ICP-723 is safe and well-tolerated in patients with advanced solid tumors. Encouraging clinical efficacy including intracranial activity was demonstrated in patients with NTRK gene fusion in various tumor types.”
Online Publication:

Efficacy and safety of orelabrutinib in diffuse large B-cell lymphoma (DLBCL): a real-world analysis

Abstract Number: e19556

Fourteen patients with MCD DLBCL were included in the study. All patients received orelabrutinib 150 mg once daily. Among them, 8 were treated with R-CHOP or R-EPOCH as first-line therapy, and 6 with RICE, R-CHOP or R2 as second-line therapy. The complete response rate (CRR) for the first-line and second-line therapy were 75.00% and 66.67%, respectively.

The leading PI concluded that orelabrutinib-containing regimens demonstrated encouraging efficacy and well-tolerated safety profile among patients with MCD DLBCL. A large-scale prospective clinical study is on registration, which would offer a new potential therapeutic option for patients with MCD DLBCL

More information can be found at ASCO official website.

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3D Printing: A Perfect Storm for Pharma Industry and Regulatory Agency(2022年)

pharmasources — 2022-09-05T11:12:09+0900

https://www.pharmasources.com/news/62213.html

3D printing or additive manufacturing is a process of creating three-dimensional solid objects from a digital design. The process involves printing sequentially thin layers of the building materials until the object is created. The earliest 3D printing technologies came about in the 1980s. Over the past decades, 3D printing has proved itself to have the potential of revolutionizing the way we make almost everything. Nowadays, 3D printing has been employed in aerospace, manufacturing, construction, medicine, and biomedical engineering. Spritam®, the levetiracetam tablets made by 3D printing technology was first approved by FDA in 2015, which marked a new chapter of making drugs. 3D printing is largely for oral solid medications accounting for the majority of marketed drug products. More over, 3D printing is able to print small batches for small patient populations. The patient-specific or personalized 3D-printed medicine tailors treatments to the individual characteristics of each patient. Its simple and decentralized production process enables locally controlled supply chain without security issues such as contaminations and frauds, but on the other side, bings in new compliance and regulatory challenges. The 3D-printing drug manufacture has created a perfect storm for the pharmaceutical industry and its regulatory agency.

3D-printing Technologies in Pharmaceutical Applications
Although not yet fully commercialized as the traditional formulation technologies, the following methods are widely used in making 3D-printed drugs [Ref. 1]: Extrusion Molding Printing (EMP), Drop On Powder Printing (DOP), Selective Laser Sintering (SLS), Stereolithography (SLA), and Electrohydrodynamic Printing (EHD). In all techniques, the printing is executed by following the model parameters preset by a computer design. Among these established methods, DOP and EMP are well studied and have become common practices [Ref. 2]. For instance, DOP is successfully employed in the production of Spritam® tablets. However, Each method has its own pros and cons, and requires further fine-tunes or big-leaps in resolving technical incompetency.

The EMP technology has two branches based on molding materials, the fused deposition modeling (FDM) and semisolid extrusion molding (SSE). In FDM method, a semifluid state of drug-loaded polymers is formed by heating, which is then extruded from the printing nozzle. The desired product is formed after solidification. The cheap and simple operation process has made FDM the most frequently used technique. However, the high heating temperature, usually over 150 °C, is not suitable for thermal-liable APIs without adding low-melting point excipients or water in the drug-loaded filaments. In contrast, the SSE technology does not involve heating process, and can be a good surrogate technique for temperature-sensitive APIs. It extrudes semisolid paste under the pressure of screw gear rotation via a syringe-based print head, and deposits the paste in layers to form the object. One of the disadvantages of SSE is using organic solvents in preparing the paste, which can lead to the residual solvents in the printed products.

DOP is similar to wet granulation used in tablet preparation with regard to solidification mechanisms. DOP sprays droplets containing binders from the print head onto the powder bed. The API can be dispersed either in the liquid or solid phases, e.g. discharging excipient binder onto API-loaded powder. After printing one layer, the platform is lowered vertically, and the new powder layer is spread over the previous layer. The procedures are repeated until the dosage form is complete. This print-glue approach offers reduced formulation complexity, as similar binders are compatible with a broad range of APIs. The method is relatively low cost, easy to scale up and produces tablets with high porosity. The limitation of DOP is its low resolution and high fragility. Post-processing is needed to eliminate residual solvents and recovery of the unprocessed powder.

In SLS, CO2 laser beam instead of binder droplets in DOP is applied to sinter the selected regions of powders in each layer with precision. SLS offers high-resolution, solvent-free, single-step 3D printing. Its process chamber is generally kept between 40 and 50 °C, filled with inert nitrogen to protect from oxidation. While its precision enables manufacturers to greatly control the microstructures of the drug products produced, SLS process is relatively slow and prone to break down APIs and excipients with high-energy laser, thus, the SLS process needs to be verified for drug degradation and mechanical properties.

SLA uses ultraviolet lasers to polymerize photosensitive resins in layers, repeating until the desired dosage form is created. It has the best resolution of 3D printing, facilitating precise structures. There are a couple of drawbacks of SLA technique: it requires post-processing to eliminate resin toxicity, the equipment is costly, few approved resins are available for the pharmaceutical field, and efficiency is low.

EHD is an emerging 3D-printing technology that can pattern fibrous material by digitally controlled deposition to create customized geometries and well-ordered complex structures. EHD 3D printing enables micro to nano-scale fiber engineering and alignment. EHD offers small-scale manufacturing to tailor medicines to meet individual patient needs by printing a vast array of APIs of predefined amounts in a specific pattern on a porous film. EHD applications are limited by low solubility, residual solvents in the dosage form, and high requirements for solution properties.

The technical, compliance, and regulatory challenges
In spite of the unique advantages of 3D-printing drug manufacture, its process and control must comply with stringent pharmaceutical standards to assure the printed drug products meet the characteristic requirements for safety, identity, strength, quality, and purity. As the structure design of a dosage form evolves during formulation development, the modeling software must be continuously updated, in addition, mechanical adjustments to the printing equipment and control systems are required to fix and prevent instrumental malfunctions such as nozzle clogging or binder leakage, which involves computer software verification, instrument qualification, and change controls.

In 3D-printing formulation, the physicochemical properties of the excipients are extremely critical to the quality of printed dosage forms. For FDM procedures, the carrier excipients are modified to prepare low-temperature filaments to prevent drug degradation and improve drug loading. For SLA and SLS, the excipients of photopolymers and laser sinterable materials are selected, but these excipients are not included in the FDA’s Generally Recognized As Safe (GRAS) list [Ref. 3]. Comparing with traditional formulation processes, the availability of excipients that can be used for 3D printing is limited. These 3D-printing suitable excipients might not be certified for pharmaceutical grade, and have compatibility issues or toxic/adverse side effects. Generally speaking, more of non-toxic, stable, biodegradable, and pharmaceutically certified excipients need to be developed to support commercialized 3D printing formulation.

The inherent nature of 3D printing is stacking layer-by-layer of polymers or powders, results in rough surface or insufficient adhesion strength. The printing procedures can also affect content uniformity, hardness, and friability, which should be listed as quality control parameters in the specifications of solid dosage form with specification limits appropriate for the decentralized, small batch 3D-printing production. Removing the residual solvents and unprocessed powders in the post-processing should be handled properly accordingly to EHS policies. Overall, the 3D printer, the printing process, the operation procedures, the API and excipients, and personnel training should be validated as a complete quality system to ensure all practices meet cGMP requirements.

About the Author:
Eric Sun, Ph.D., a seasoned pharmaceutical professional, has diverse experiences in both U.S. and China pharmaceutical industry. He has led research and development, clinical supplies, compliance, and regulatory filing activities at big pharmas, startups, and CROs/CDMOs. His recent interest has been channeled to improve the overall R&D productivity and success rate ensuring the delivery of the beneficial therapeutics to the clinic in an optimum timescale with minimum safety concerns.

Pharma Sources Insight April 2022: An Overview on BIopharma and API in China and the World(2022年)

pharmasources — 2022-09-05T11:11:39+0900

https://www.pharmasources.com/products/catid/bio-products-104.html

About Pharma Sources Insight
Pharma Sources Insight is a unique source of updated coverages on current events and deep insights into hot areas of the pharma industry, from China to the world. It follows up new developments with those among the leading drug-manufacturers in China which further affect the world.

Now, join PharmaSources.com to get access to news of the Chinese pharmaceutical enterprises and medical suppliers to witness industrial changes through the exclusive perspectives of our expert writers into crucial aspects of the pharmaceutical field, all under PharmaSources.com and CPhI China.

Pharma Sources Insight August 2021 focuses on the following topics and more:
Brand Story

- Jornen - Innovative Machine for Your Pharmaceutical Blister/Cartoning Packaging

GLOBAL Market Review

-The Impact of Russian-Ukrainian conflict on Pharma Business

-Trends and Developments in HIV Research

-With Sky-high Price, CAR-T Therapy Sold at Least USD 1,709 Billion in 2021

-The Boosting Bispecific Antibody Therapeutics Market: Market Size Exceeded USD 3.5 Billion by 2021

PHARMA IN CHINA

-Popular Products and Companies at PharmaSources

-Perspective on the Development Trend of Specialty APIs Supported by Policies in China

-A New Record of the Innovative TCM Approval with the Reform of China’s Review and Approval Systems

As a professional bio pharmaceuticals company, we provide biological pharma products, if you want to know biopharmaceutical products list, contact us.

International Perspective, Cutting-edge Technology Learning - Entering into HongKe(虹科) Technology Co., Ltd.(2022年)

pharmasources — 2022-09-05T11:10:54+0900

https://www.pharmasources.com/company-home/hongke-technology-co-ltd-userId-33347.html

HongKe(虹科) Technology Co., Ltd., established in 2007 (previously HongKe(宏科) founded in 1995), is headquartered in Guangzhou, the economic and cultural center of southern China. The products and services provided by Hongke cover the fields of environmental monitoring (laboratory, pharmaceutical production), data collection of pharmaceutical supply chain, and biotechnology. For over a decade, the company has accumulated a wealth of knowledge and technology. Coupled with the technical and product cooperation with the world’s top companies from the United Kingdom, Germany, Switzerland and Denmark, HongKe has leading technology and innovative capabilities in the industry. On this basis, it is committed to providing Chinese users with high-quality, multi-functional integrated systems and solutions, as well as premium consulting, maintenance and training services.
In environmental monitoring of the pharmaceutical supply chain, HongKe is a high-tech company with 12 years of experience. HongKe cooperates with ELPRO from Swiss and ELLAB from Denmark, both representing the world’s top level and high-end quality, to provide users with temperature and humidity monitoring solution, verification system, calibration system, and related services in all processes of the pharmaceutical supply chain.

All staff of the business unit have an average of 5-year-plus industrial experience, regulatory knowledge and technical capabilities, have received professional training at home and abroad and obtained qualification certifications. So far, HongKe has provided a large number of temperature and humidity recorders, environmental monitoring system, verification system, calibration system and consulting services for scientific research institutions, biopharmaceuticals, pharmaceutical supply chain and other companies for R&D, production, operation, and application.

Because of the professional services and support of engineers, HongKe wins an excellent reputation in the pharmaceutical industry. HongKe also actively participates in the work of industry associations and has made important contributions to promoting advanced technologies. The business unit regards it as a lifelong pursuit to guarantee medical quality so that patients can have access to safe medicines.

With its advanced medicine coolchain transportation solutions, HongKe has been deeply involved in medicine, biology and clinical for more than 14 years. Based on the customer experiences, HongKe in-depth cooperate with international leading experts in the field of life sciences, strategically entered the field. Products provided include water baths, shakers, mixers, centrifuges, cell analyzers, sterilization, refrigeration, image analysis, quality certification and calibration services.

HongKe Biotechnology business unit is guided by customer needs and based on technical capabilities, providing the most fittable solutions and most satisfactory services for domestic scientific research institutions, enterprises and institutions for experimental research, medicine research and development, etc. Life science engineers have received many years of training and guidance from experts from the United Kingdom, the United States, Denmark, etc., and have completed many in-depth parameters comparison and product selection, experiments and reports, and also led and participated in some laboratories with technology upgrade project,such as Roche, Merck,Bethune Hospital and so on.

In recent years, HongKe has developed rapidly, become a well-known company in the field and won many industry awards. It has played an important role in many industry associations around the world, such as CiA, PI, ISPE, and AWE. The users served include BMW, NIO, Bosch, Roche Pharmaceuticals, Intel, Huawei, Tencent, China Mobile, CSR, Tsinghua University, etc. HongKe has been awarded as the High-tech Enterprise, Technology Innovation Enterprise, Great Credit Enterprise; and has continuously won domestic and foreign industry and association awards, including the Best Employer Award, the Most Competitive Innovative Product, the Best Product Award, etc.

At present, HongKe has branches in Guangzhou, Beijing, Shanghai, Xi’an, Chengdu and Suzhou, and sales representatives in South Korea, Japan, Shenyang, Tianjin, Nanjing, Hefei, Hangzhou, Wuhan, Shenzhen, Zhengzhou, Chongqing, Qingdao, etc. The company also set up branches in Taiwan, Hong Kong and Silicon Valley, with partners and users around the world.

Goal：New standard as a prominent company

Ambition：Growing into a world-class company

Positioning： To be qualified,complete solutions and technology localized provider

Belief：Customer satisfaction is the only path to a world-class company.

Strategies：

Continuous technical innovation

Flexible and malleable company

Adherence to our values

Values：

Focus: Guarantee quality and deliverability

Creed: Be ethical, wise, dedicated, and achieve growth

Promise: World-class quality with reasonable price

Team: Energetic, multi-functional, and proactive

Culture: Technology-and-profession-standing, joyful and interesting working environment

HongKe LOGO

International Perspective, Cutting-edge Technology Learning

HongKe has been cooperating with the world's top companies for a long time, and providing employees with diversified online or offline international exchange opportunities. In HongKe, you will be heavily involved in international technical cooperation, experience different teamwork and innovative atmosphere, and may become a disciple of international experts.

Popular Products and Companies at PharmaSources.com (April 2022)(2022年)

pharmasources — 2022-09-05T11:10:17+0900

https://www.pharmasources.com/products/multi-functional-intelligent-automatic-c-256487.html?utm_source=PS&utm_medium=News&utm_campaign=PSIJUNE2022
https://www.pharmasources.com/products/palladium-hydroxide-on-carbon-266217.html?utm_source=PS&utm_medium=News&utm_campaign=PSIJUNE2022

Popular Products and Companies at PharmaSources.com
TOP 10 Hot Products of PharmaSources.com
No.Product NameCAS No.Company Name
150x4 Supercritical CO2 Extraction Machine/SHANGHAI CHENGDONG TECHNOLOGY CO.,LTD
2(1R,2S,5S)-3-((S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexan-2-carboxylic acid2755812-45-2Jinan Jianfeng Chemical Co., Ltd.
3Diclofenac Sodium15307-79-6Arshine Pharmaceutical Co., Ltd.
4Hualan Bio-H7N9 Inactivated Influenza Vaccine/Hualan Biological Bacterin Inc.
5vacuum roller drier,sahara milk drier/Shanghai MinJie Machinery Co. Ltd.
6CVC1266 BOTTLE UNSCRAMBLER/CVC TECHNOLOGIES,INC.
7Cyclen(Contract Manufacturing available)294-90-6Chengdu Dawn Pharmaceutical Technology Co., LTD
8CVC TABLET & CAPSULE PACKAGING SYSTEMS/CVC TECHNOLOGIES,INC.
9Multi-functional intelligent automatic cartoning machine/Shanghai Wanshen Packaging Machinery Co., Ltd.
10Palladium hydroxide on carbon12135-22-7HANGZHOU DINGYANCHEM CO.,LTD

Pharma Sources Insight June 2022: New Developments of COVID-19, Greater Impact on the Pharma Market(2022年)

pharmasources — 2022-09-05T11:09:39+0900

https://www.pharmasources.com/news/standards-for-integrity-testing-75857.html
https://www.pharmasources.com/news/3d-printing-75841.html

Pharma Sources Insight June 2022 focuses on the following topics and more:
Brand Story

- International Perspective, Cutting-edge Technology Learning, Entering into Hongke Technology Co., Ltd.

Fighting Against COVID-19

- Outlook for Covid-19 in 2022 H2 and Its Broader Impact on the Pharma Market

- With First Chinese Small-molecule Oral Drug for COVID-19 Coming, What New Opportunities are Ushered in by the Relevant Industry Chain

- Is mRNA Vaccine the Source of Intricacies of "Mysterious Hepatitis"?

GLOBAL Market Review

- First Drug Coming Soon as Pharmaceutical Companies Take Actions in the B7-H3 Immune Target Products Layout

- Antibody-Drug Conjugates - Lessons Learned

PHARMA IN CHINA

- Popular Products and Companies at PharmaSources

- Chinese Pharmaceutical Companies Entering the DC Vaccine Market Under the Support of Tens of Millions of Financing

- IPOs Review of Chinese Biomedical Companies in 2021

INDUSTRY INSIGHT

- Standard for Integrity Testing

- 3D Printing, A Perfect Storm for Pharma Industry and Regulatory Agency

How to read the full issue?
1. Register or Log in and click Download PSI for Free below.

2. Register or Log in to show the password, copy the password and unlock the full issue.

CPHI China opens for international partnering after China rises in CPHI Index(2022年)

pharmasources — 2022-09-05T11:08:50+0900

https://www.cphi.com/china/en?utm_source=media&utm_medium=online&utm_campaign=enpsPRN
https://www.pharmasources.com/vec2022/register?utm_source=media&utm_medium=online&utm_campaign=enpsPRN

The CPHI China Hosted Buyer Programme is empowering new partnering in China

8th June, 2022, Shanghai: CPHI & P-MEC China opens its online international partnering platform as pharmaceutical and biopharmaceutical industries in the country report strong underlying conditions and see increases in all categories of the most recent CPHI Pharma Index[1] – an annual score of each country’s pharma industry strength – with its overall score rising by 7.2%, the largest increase of any nation.

The two-month digital partnering platform takes on increased importance with the postponement of the in-person exhibition until December (20th-22nd) 2022. CPHI & P-MEC China’s online event opened on April 21st and will continue until June 30th 2022 and is designed to empower international companies by helping them pre-select new partners and begin discussions earlier.

“There is a great deal of interest for partnering in China, as discovery and manufacturing continue to grow and, of course, it remains the largest producer of pharmaceutical ingredients – so in the absence of an in-person event we knew we had to offer alternatives. In fact, to help our international attendees meet with the right contacts we also offer a Hosted Buyer Programme, with our teams taking a brief and selecting the best partners for any international buyer’s needs. High quality partners are in great demand and we wanted to simplify process of nurturing new contacts,” commented Laura Murina, Brand Manager at CPHI & P-MEC China.

China recorded the largest year-on-year gains in the CPHI Pharma Index[2] for ‘solid dose manufacturing innovation’, ‘quality of bioprocessing’ and ‘API manufacturing’ – with rises of 9.5%, 11% and 7.4% respectively – and international companies should anticipate the need to source partners much earlier as demand rises. Further fuelling competition for the best manufacturing partners is the increasing numbers of biotechs in the country and the MAH (Marketing Authorization Holder) programme.

The Virtual Expo Connect has been designed to help companies from around the globe meet with over 2,500 suppliers and prospective partners. The platform is flexible and allows registered users to either research suppliers themselves or to apply for the Hosted Buyer Programme. The virtual one-on-one meetings for hosted buyers can be held as soon as meetings are confirmed until when the platform closes on 30th June, with online connections available now. The programme is supported by a trained multilingual customer services team and has been specifically designed to help international audiences meet and match with domestic and regional suppliers. CPHI & P-MEC China is encouraging all international attendees to utilise its Hosted Buyer Programme.

In fact, the programme is a significant driver of new sourcing in the country and is used by many international companies: not only to meet partners immediately, but also, as a pre-selection tool to research a wider array of partners ahead of more detailed meetings later in the year.

Additionally, international audiences will be able to gain the latest insights and trends from across China via the Online Content Program with on-demand webinars, including sessions on ‘China-EU Biotech/Medtech Market access’ and ‘Generic Drug Applications’. A weekly pharma news podcast, in association with PharmaVibe, will also be available for the attendees throughout the online event.

International attendees can register now for CPhI & P-MEC China 2022 Virtual Expo Connect here.

Murina emphasised the continued strength of Chinese Pharmaceutical industry adding: “China’s pharmaceutical market continues to show great diversity and growth in the short and medium term, with manufacturers continuing to innovate new processes and products. Demand for partners is therefore incredibly competitive, and we would encourage anyone looking to work in China to take part in the online event and ensure they further advance the building of their local networks.”
About CPHI

CPHI is the leading global community for pharmaceutical professionals, hosting
a portfolio of digital and in-person connection opportunities across the whole pharma supply chain on a scale like no other

At the heart of Pharma

About Informa Markets

Informa Markets creates platforms for industries and specialist markets to trade, innovate and grow. Our portfolio is comprised of more than 550 international B2B events and brands in markets including Healthcare & Pharmaceuticals, Infrastructure, Construction & Real Estate, Fashion & Apparel, Hospitality, Food & Beverage, and Health & Nutrition, among others. We provide customers and partners around the globe with opportunities to engage, experience and do business through face-to-face exhibitions, specialist digital content and actionable data solutions. As the world’s leading exhibitions organizer, we bring a diverse range of specialist markets to life, unlocking opportunities and helping them to thrive 365 days of the year.

For more information, please visit www.informamarkets.com

CPhI South East Asia (19-21 Oct 2022 at IMPACT, Thailand); CPhI, ICSE, P-MEC, FDF, InnoPack Worldwide, BioProduction (01-03 November 2022 at Messe Frankfurt, Frankfurt); CPhI & P-MEC India (29 November – 1st December 2022 at the India Expo Mart, Greater Noida, Delhi NCR – Delhi, India); CPhI & P-MEC China (20-22 December 2022 at SNIEC – Shanghai, China); Pharmapack Europe (1-2 Feb, 2023 at Paris Expo, Porte de Versailles - Hall 7.2, Paris); CPhI Japan (19-21 April, 2023 at the Big Sight Exhibition Centre – Tokyo, Japan); CPhI North America (25-27 April, 2023 at Pennsylvania Convention Center, United States),

Quality Sourcing Opportunities at 2022 Zhejiang Export Commodity Online Fair “Thailand & Indonesia - Natural Extracts Session”!(2022年)

pharmasources — 2022-09-05T11:08:07+0900

https://www.pharmasources.com/
https://www.pharmasources.com/zt/api_skjp#003
https://jinshuju.net/f/JoOV9s

The 2022 Zhejiang Export Commodity Online Fair (Pharma Sector) is coming with a new session. The portals for the “Thailand & Indonesia - Natural Extracts Session” is now launched to welcome the participation of both pharmaceutical suppliers located in Zhejiang Province of China, as well as the buyers from Thailand & Indonesia online.

Jointly held by the Department of Commerce of Zhejiang Province, Zhejiang Times International Exhibition Services, and Shanghai Sinoexpo Informa Markets International Exhibition, 2022 Zhejiang Export Commodity Online Fair will be launched continuously at the digital portal - PharmaSources.com to facilitate ongoing and new business connections between Zhejiang and Thailand & Indonesia pharma markets, relieve and fill in the demand gaps at this challenging time of travel restrictions.

This is not the first session held for Natural Extracts products since the launch of Zhejiang Export Commodity Online Fair. Back to 2021, the Thailand & Indonesia – Natural Extracts session has showcased close to 2000 products from 50 suppliers, which attracted more than 60 overseas buyers and received more than 180 inquiries from Thailand and Indonesia buyers.

Zhejiang Export Commodity Online Fair provides an excellent platform with dedicated services to display high-quality products and establish an effective communication channel. From 2020 to now, Zhejiang Export Commodity Online Fair has assembled manufacturers of APIs, pharmaceutical intermediates, fine chemicals, pharmaceutical machinery and equipment, natural extracts, and other products from Zhejiang Province, serving both domestic pharmaceutical companies and overseas buyers from Europe, Americas, Asia, the Middle East and other parts of the world.

While the 3 online sessions held from February to May this year have gathered over 120 Zhejiang pharma companies (6% are first-time participants), attracted 315 overseas buyers to participate, and facilitated more than 600 business matchmaking. As the 4th session of this year, the Thailand & Indonesia Station – Natural Extracts Session will start on 20th June and last for 11 days until 30th, and is free of charge to Zhejiang pharmaceutical companies and buyers from Thailand & Indonesia. As part of the Online Fair series, the event will provide one-to-one matchmaking services in form of video meetings for easier and more efficient communication. The pharmaceutical companies will be able to e-meet their potential partners online with no constraints of time and space.

Zhejiang Export Commodity Online Fair (Pharma Sector) provides a great online platform for buyers depending on its strong database to extend connections and explore opportunities to network and trade with pharma enterprises. Genuinely, we are all here to serve the whole pharmaceutical industry!

Features Introduction

· Digital Marketplace*
Nearly 400 Suppliers from Zhejiang China will be displayed online, covering natural extracts, pharma manufacturing and packaging machinery, pharma intermediates and fine chemicals products. Buyers can select and explore detailed supplier profiles & products online.

· Matchmaking - Explore More at PharmaSources
China Pharma Connect is an online matchmaking system that enables suppliers and buyers to browse and search for potential business partners and products, send invitations and get connected online.

· EZSourcing - Post Sourcing Requests
Popular products and the purchasing requirements will be posted online and buyers can submit purchasing demand and request for quotations.

· Cloud Meeting - Join Video Meeting
The Cloud Meeting service enables suppliers and buyers to enjoy convenient “screen to screen” meeting with each other. Buyers can sign up and submit specific purchasing products requirement and access personalized matchmaking services to make appointments and attend one-on-one video meetings for business negotiations. Sign Up Now

About PharmaSources.com
Rolled out in 2010 as an online trade platform serving the pharmaceutical industry, PharmaSources.com has been renamed and rebranded from EN-CPhI.cn after over 10 years’ driving industry development. PharmaSources.com is committed to establishing an international trade platform to connect global pharma buyers and qualified suppliers while continuously promoting trade and development across the pharmaceutical industry.

TCM Raw Materials Products(2022年)

pharmasources — 2022-08-17T11:35:58+0900

https://www.pharmasources.com/products/catid/tcm-raw-materials-903.html

TCM Raw Materials Products

anti-oxidant fish collagen peptide for cosmetics
Category:Natural Extracts > Cosmetics Raw Materials
Product Name:anti-oxidant fish collagen peptide for cosmetics
CAS No.:9007-34-5
Standard:ChP, USP, BP, EP, JP, In-house Standards, IP, Ph. Int
Price(USD):Negotiable

Basic Info
Grade: cosmetics grade

Factory Location: Shandong Weifang

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

Monthly Production Capacity: 30-50mt

Contract Manufacturing: CRO,CMO

Packaging Information: 1kg/bag,5kg/bag,20kg/drum

Delivery Lead Time: 1week

Sample Provided: yes

Payment Terms: L/C

Collagen is the main component of animal connective tissue.It is also the most widely distributed functional protein in animals.fish collagen peptide is superior in some aspects of terrestrial animal collagen,by virtue of a low antigenicity,hypoallergenic properties,due to its differences in amino acid composition and degree of cross linking.

Supplement collagen to skin

Moisture and release wrinkle

Strenthen skin’s elasticity

Be benefit to bone and joint health

We also have types of Raw Material For Traditional Chinese Medicine for sale, if you have needs, please contact us.

https://eimg.pharmasources.com/image/20220808/nzVBtKk0hO0vS83QwOk35lTzyhMsXr6aDEPbsRHg.jpeg!371

Plant Extracts Products(2022年)

pharmasources — 2022-08-17T11:35:19+0900

https://www.pharmasources.com/products/catid/plant-extracts-76.html

Andrographolide
Category:Natural Extracts > Plant Extracts
Product Name:Andrographolide
CAS No.:5508-58-7
Standard:ChP, In-house Standards
Price(USD):9-10
Company:Hangzhou Deli Chemical Co.,Ltd.

Basic Info
Grade: pharma grade

Factory Location: Hunan

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Asia,Middle East

Monthly Production Capacity: 100

Packaging Information: 25kg per drum

Sample Provided: yes

Payment Terms: T/T

Andrographolide is the bitter principle, a colorless and neutral crystalline substance. It is the major labdane diterpenoid isolated from Andrographis paniculate. It exhibits antiviral, anti-inflammatory, and anticancer activities.

As one of plant extracts manufacturers and plant extracts suppliers, we have list of plant extracts for sale, if you have needs, please contact us.

Nutrition & Health Product Raw Materials Products(2022年)

pharmasources — 2022-08-17T11:34:50+0900

https://www.pharmasources.com/products/catid/nutrition-health-product-raw-materials-900.html

90% content small molecule soybean peptide
Category:Natural Extracts > Nutrition Raw Materials and Health Product Raw Materials
Product Name:90% content small molecule soybean peptide
CAS No.:107761-42-2
Standard:ChP, USP, BP, EP, JP, In-house Standards, IP, Ph. Int
Price(USD):Negotiable

Basic Info
Grade: food grade

Factory Location: Shandong Weifang

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

Monthly Production Capacity: 30-50mt

Contract Manufacturing: CRO,CMO

Packaging Information: 1kg/bag,5kg/bag,20kg/drum

Delivery Lead Time: 3-5days

Sample Provided: yes

Payment Terms: D/P

Soybean is a good source of vegetable protein,while is has lower bioavailability than animal proteins due to its complex molecular structure and high molecular weight.

Hailongyuan’s soybean peptide is produced by directional enzyme digestion technology and multiple membrance seperetion technology,which can keep most of the active peptides.

Natural Extracts Products(2022年)

pharmasources — 2022-08-17T11:34:18+0900

https://www.pharmasources.com/products/catid/natural-extracts-75.html

Natural Extracts Products
Natural extracts products are the biological raw materials extracted or processed from animals and plants, which can apply in the pharmaceutical industry, food industry, functional food and supplements industry, cosmetic and skincare industry, and other industries.
anti-oxidant fish collagen peptide for cosmetics
Category:Natural Extracts > Cosmetics Raw Materials
Product Name:anti-oxidant fish collagen peptide for cosmetics
CAS No.:9007-34-5
Standard:ChP, USP, BP, EP, JP, In-house Standards, IP, Ph. Int
Price(USD):Negotiable

Basic Info
Grade: cosmetics grade

Factory Location: Shandong Weifang

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

Monthly Production Capacity: 30-50mt

Contract Manufacturing: CRO,CMO

Packaging Information: 1kg/bag,5kg/bag,20kg/drum

Delivery Lead Time: 1week

Sample Provided: yes

Payment Terms: L/C

Supplement collagen to skin

Moisture and release wrinkle

Strenthen skin’s elasticity

Be benefit to bone and joint health

As professional herbal extracts manufacturers, we have types of herbal extracts wholesale for sale, if you have needs to buy natural herbal extracts, please contact us.

We are also natural extracts suppliers, if you want to know more details, please visit our website.

Microbe Extracts Products(2022年)

pharmasources — 2022-08-17T11:33:46+0900

https://www.pharmasources.com/products/catid/microbe-extracts-746.html

Angel Active Yeast Powder
Category:Natural Extracts > Microbe Extracts > Yeast & Yeast Extracts
Product Name:Angel Active Yeast Powder
Price(USD):Negotiable
Company:Angel Yeast Co.,Ltd.

Basic Info
Factory Location: Yichang, Hubei, China

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

Monthly Production Capacity: 1000MT

Packaging Information: 20KG/Bag

Delivery Lead Time: 30 days

Sample Provided: yes

Payment Terms: T/T

Product name

Angel yeast powder (active yeast) YA200

Definition

Angel yeast powder (active yeast) YA200 is a kind of inactive yeast which is obtained from Saccharomyces cerevisiae yeasts.

Description

Light beige to yellow, powder form, not totally soluble in water.

Application

As active yeast, can be widely used in below applications:

animal feeding additives, aquaculture, sewage treatment etc.

Certification

Kosher, Halal, ISO9001, ISO14001, ISO22000, Sedex, BRC, CNAS

Food & Beverage Raw Materials Products(2022年)

pharmasources — 2022-08-17T11:33:15+0900

https://www.pharmasources.com/products/catid/food-beverage-raw-materials-901.html

Food Raw Materials List

high protein soybean peptide for food
Category:Natural Extracts > Food & Beverage Raw Materials
Product Name:high protein soybean peptide for food
CAS No.:107761-42-2
Standard:ChP, USP, BP, EP, JP, In-house Standards, IP, Ph. Int
Price(USD):Negotiable

Basic Info
Grade: food grade
Factory Location: Shandong Weifang
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Monthly Production Capacity: 30-50mt
Contract Manufacturing: CRO,CMO
Packaging Information: 1kg/bag,5kg/bag,20kg/drum
Delivery Lead Time: 5days

Sample Provided: yes

Payment Terms: T/T
Advantages/characteristics
small molecular peptides,average molecular weight is less than 1000da,contain many bioactive peptides
Non GMO soybean origin
Easy to absorb,the absorption rate is 20 times of common protein and 3 times amino acid
Perfect amino acid ratio:be rich in 18 kinds of necessary amino acids for human,and its ratio meets human requirement
Good physiochemical and processing properties,good solubility and flowability,high transparency,low salt.

Cosmetics Raw Materials Products(2022年)

pharmasources — 2022-08-17T11:32:48+0900

https://www.pharmasources.com/products/catid/cosmetics-raw-materials-904.html

Cosmetics Ingredients Wholesale

Basic Info
Grade: cosmetics grade

Factory Location: Shandong Weifang

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

Monthly Production Capacity: 30-50mt

Contract Manufacturing: CRO,CMO

Packaging Information: 1kg/bag,5kg/bag,20kg/drum

Delivery Lead Time: 1week

Sample Provided: yes

Payment Terms: L/C

Supplement collagen to skin

Moisture and release wrinkle

Strenthen skin’s elasticity

Be benefit to bone and joint health

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Animal Extracts Products(2022年)

pharmasources — 2022-08-17T11:32:20+0900

https://www.pharmasources.com/products/catid/animal-extracts-77.html

Chenodeoxycholic acid
Category:Natural Extracts > Animal Extracts
Product Name:Chenodeoxycholic acid
CAS No.:474-25-9
Standard:ChP, In-house Standards
Price(USD):Negotiable
Company:Hangzhou Deli Chemical Co.,Ltd.
Basic Info
Grade: pharma grade
Factory Location: Hunan
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Asia,Middle East

Monthly Production Capacity: 100tons
Packaging Information: 25kg per drum
Delivery Lead Time: prompt
Sample Provided: yes
Payment Terms: L/C

Chenodeoxycholic acid is a bile acid synthesized in the liver from cholesterol. henodeoxycholic acid has been used in a study to assess its effects as a long-term replacement therapy for cerebrotendinous xanthomatosis (CTX). It has also been used in a study to investigate its effects on the small-intestinal absorption of bile acids in patients with ileostomies.

Atreca Appoints Stacey Ma and Stephen Brady to its Board of Directors(2022年06月23日)

pharmasources — 2022-06-17T10:22:04+0900

https://www.pharmasources.com/products/catid/natural-extracts-75.html

Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced the appointment of Dr. Stacey Ma, Executive Vice President and Head of Technical Operations at Sana Biotechnology, and Stephen R. Brady, Chief Executive Officer of Tempest Therapeutics, to its Board of Directors.

"We are pleased to be expanding our Board of Directors with the addition of two experienced and accomplished biopharmaceutical executives" said John Orwin, Chief Executive Officer. "Together, Stacey and Steve bring over 40 years of industry experience across a variety of corporate functions, including research, technical operations, manufacturing, corporate development and finance. Their expertise will be invaluable to Atreca as we continue to advance ATRC-101 and build our preclinical pipeline."

Dr. Stacey Ma
Dr. Ma is currently the Executive Vice President and Head of Technical Operations at Sana Biotechnology, a publicly listed biotechnology company, where she has served since March 2019. From 1996 to 2019, she served various roles at Genentech/Roche, a biotechnology company, including as their Global Head of Innovation, Manufacturing Science and Technology from March 2018 to March 2019, and as Vice President, Global Head of Investigational Medicinal Products (IMP) Quality from May 2015 to February 2018. From July 1996 to May 2015, she held various other roles related to analytical development, pharmaceutical development, quality, technical product management and supply chain.

Stephen R. Brady
Mr. Brady is currently the Chief Executive Officer of Tempest Therapeutics, a publicly listed biotechnology company. Previously, he served as the President and Chief Operating Officer at Tempest from September 2019 to June 2021. Prior to joining Tempest, he served in various leadership roles at Immune Design Corp., including as Executive Vice President, Strategy & Finance from May 2015 until its sale to Merck in 2019, and as Chief Business Officer from September 2013 to May 2015. Prior to Immune Design, Mr. Brady served in various leadership roles at 3-V Biosciences, Inc. (now known as Sagimet Biosciences Inc.), including as Chief Business Officer from February 2011 to August 2013, and as Vice President, Corporate Development, Strategy and Operations from February 2010 to February 2011. From April 2007 to March 2010, Mr. Brady held various roles at Proteolix, Inc., most recently serving as Vice President of Corporate Development.

About Atreca, Inc.
Atreca is a biopharmaceutical company developing novel antibody-based immunotherapeutics generated by its differentiated discovery platform. Atreca's platform allows access to an unexplored landscape in oncology through the identification of unique antibody-target pairs generated by the human immune system during an active immune response against tumors. These antibodies provide the basis for first-in-class therapeutic candidates, such as our lead product candidate ATRC-101. A Phase 1b study evaluating ATRC-101 in multiple solid tumor cancers is currently enrolling patients.

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Cytokinetics Announces Proposed Public Offering of Common(2022年06月23日)

pharmasources — 2022-06-17T10:21:28+0900

https://www.pharmasources.com/products/catid/animal-extracts-77.html
https://www.pharmasources.com/products/catid/cosmetics-raw-materials-904.html

Cytokinetics, Incorporated (Nasdaq:CYTK) today announced plans to offer, subject to market and other conditions, $200,000,000 of shares of its common stock in an underwritten public offering. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Cytokinetics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. All of the shares of common stock in the offering will be sold by Cytokinetics.

J.P. Morgan and Morgan Stanley are acting as joint book-running managers for the offering. Mizuho Securities and JMP Securities are acting as passive book-runners.

The securities described above are being offered by Cytokinetics pursuant to a shelf registration statement (including a prospectus) filed on November 6, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC's website athttp://www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone: 1-866-803-9204, or by email at prospectus-eq_fi@jpmchase.com; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at 866-718-1649 or by email at prospectus@morganstanley.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.

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