Pharma Tech

WuXi STA and BioLingus sign exclusive technology and marketing collaboration for sublingual delivery(2023年)

Eric_Xu — 2023-06-27T12:17:53+0900

SHANGHAI and SAN DIEGO, Feb. 18, 2019 /PRNewswire/ -- STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, and BioLingus, a Swiss biotech company, announce they have formed an exclusive technology and marketing collaboration for sublingual delivery.

Under the terms of the collaboration, WuXi STA will have exclusive access to BioLingus technology for sublingual and buccal delivery in the contract development and manufacturing organization (CDMO) sector. BioLingus has developed a novel platform - with patents secured in major countries around the world - to stabilize and deliver sublingually (orally under the tongue) drug targets including small molecules, peptides and proteins that are currently administered to patients via injection.

The collaboration will help further integrate the advantages of WuXi STA drug product services and expedite the development of BioLingus' pipeline and usage of sublingual delivery technology.

In 2017, WuXi STA merged with WuXi AppTec's Pharmaceutical Development Services unit, realizing a seamless integration of the entire chemistry, manufacturing and controls (CMC) supply chain. Over the past year, two new commercial drug product facilities - in Shanghai and Wuxi city, Jiangsu province - have come into operation, enabling WuXi STA to support solid dosage drug development from pre-clinical to commercial, with several phase III and commercial drug product projects underway. The newly introduced sublingual delivery technology will further deepen the scale of solid dosage drug capabilities in WuXi STA, providing customers with more flexible, diverse and advanced solutions.

"We entered into this exclusive collaboration with WuXi STA for this technology in the CDMO sector for a number of reasons. Principally, WuXi STA is one of the world leaders in this field, with an integrated CMC platform from pre-clinical development to commercialization. Furthermore, this partnership will help us develop our own client base on a global scale faster and more broadly than we could do on our own," said Yves Decadt, CEO of BioLingus.

Dr. Minzhang Chen, CEO of WuXi STA, added: "We are very pleased to partner with BioLingus and to offer their award-winning sublingual delivery technology to global new drug developers via WuXi STA's integrated CMC platform. This collaboration will therefore offer more economical, convenient and effective delivery solutions for patients globally."

WuXi STA and Ark Biosciences Sign CMC Development and Manufacturing Agreement(2023年)

Eric_Xu — 2023-06-27T12:16:48+0900

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Ark Biosciences, a global biotech company focusing on innovative drug discovery and development, especially in the area of viral infection and respiratory disease, today announced a strategic partnership for CMC development and manufacturing.

Under the terms of the collaboration, Ark Biosciences will utilize the Marketing Authorization Holder (MAH) scheme to accelerate drug development and WuXi STA will provide an integrated solution in process R&D and manufacturing.

Ark Biosciences’ pipeline includes active discovery programs of its own, those of its partners, as well as in-licensed drug assets for clinical development. Ark’s leading program, a novel respiratory syncytial virus (RSV) F-protein inhibitor Ziresovir (AK0529), has completed three phase I clinical trials and is currently in global multi-center phase II clinical trial. The company also entered into a license agreement with Roche in August 2018 for the global rights of a potential new standard-of-care treatment for idiopathic pulmonary fibrosis.

WuXi STA was selected as the strategic partner thanks to its industry leading “end-to-end” CMC platform for new drug development from preclinical to commercial – for both API and finished dosage forms – as well as its expertise and track record for meeting global quality standards. The company is at the forefront of implementing China’s MAH pilot program and is helping many domestic innovative drug development partners. By using WuXi STA, partners are able to optimize manufacturing processes, significantly reduce commercial production costs, mitigate business risk, and improve operational efficiency.

“We’re delighted to partner with such a well-respected, world-class CDMO such as WuXi STA,” said Dr. Jim Wu, CEO of Ark Biosciences. “WuXi STA’s enabling end-to-end CMC platform, scale, and innovation capabilities will help us to move our drug candidates from the clinical-stage to commercialization more efficiently.”

Dr. Minzhang Chen, CEO of WuXi STA, commented: “Our mission is to empower and accelerate customers to develop innovative drugs from clinical to commercial – faster and more efficiently. We are delighted to become the strategic partner of Ark Biosciences and look forward to helping them advance their drug candidates towards the clinic, bringing innovative medicines for the benefit of patients around the world.”

Formulation development#

WuXi STA Forms Strategic Partnership with Beta Pharma(2023年)

Eric_Xu — 2023-06-27T12:15:54+0900

STA will Accelerate Process R&D and Manufacturing of Late Phase and Commercial Targets

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Beta Pharma, a biotech company focusing on innovative drug discovery and development in oncology, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Beta Pharma, leveraging its platform to accelerate process R&D and manufacturing of later phase and commercial production – utilizing the Marketing Authorization Holder (MAH) scheme. Dr. Xiaodong Zhang, Founder and Chairman of Beta Pharma and Dr. Minzhang Chen, CEO of WuXi STA attended the strategic cooperation signing ceremony.

Beta Pharma is an emerging specialty pharmaceutical company dedicated to the discovery, development, and commercialization of innovative late stage therapies targeting oncology. The company has a pedigree spanning some 20 years of experiences in anticancer therapies and drugs and its founder Dr. Xiaodong Zhang and his team even participated in the molecular invention, development and listing in China of the first small molecule targeted anticancer drug, Icotinib. Today, Beta Pharma continues to expand its pipeline to integrate anticancer drugs and therapies, such as biopharmaceuticals, into its long-term development planning and strategies.

In February 2019, Beta Pharma officially launched the China registered Phase IIb, III clinical trial or the target BPI-7711 – a third generation of EGFR TKI that has a highly selective inhibitory effect on T790M mutations and EGFR single mutant tumors after a generation of EGFR TKI resistance. The company also has another target, BPI-1178, which has completed pre-clinical research and is expected to submit clinical application in early 2019.

WuXi STA was chosen as the strategic partner thanks to its industry leading “end-to-end” CMC platform for new drug development from preclinical to commercial – for both API and finished dosage forms – as well as its expertise and track record for meeting global quality standards.

“We’re delighted to partner with such a well-respected, world-class CDMO such as WuXi STA,” said Dr. Xiaodong Zhang, Founder and Chairman of Beta Pharma. “WuXi STA’s enabling end-to-end CMC platform and efficient, flexible solutions that meet the timeliness of our clinical and commercial use, will enable us to advance our pipeline more quickly worldwide.”

Dr. Minzhang Chen, CEO of WuXi STA, commented: “Our mission is to empower and accelerate customers to develop innovative drugs from clinical to commercial – faster and more efficiently. We are delighted to become the strategic partner of Beta Pharma and look forward to helping them advance their drug candidates towards the clinic, bringing innovative medicines for the benefit of patients around the world.”

WuXi STA Forms Strategic Partnership with Beta Pharma(2023年)

Eric_Xu — 2023-06-27T12:13:29+0900

STA will Accelerate Process R&D and Manufacturing of Late Phase and Commercial Targets

Dr. Minzhang Chen, CEO of WuXi STA, commented: “Our mission is to empower and accelerate customers to develop innovative drugs from clinical to commercial – faster and more efficiently. We are delighted to become the strategic partner of Beta Pharma and look forward to helping them advance their drug candidates towards the clinic, bringing innovative medicines for the benefit of patients around the world.”

Formulation development#

WuXi STA's New Drug Product Manufacturing Facility Passes First European MPA GMP Inspection(2023年)

Eric_Xu — 2023-06-27T12:12:50+0900

SHANGHAI, March 27, 2019 /PRNewswire/ -- STA Pharmaceutical Co., Ltd., (WuXi STA) - a subsidiary of WuXi AppTec - announces that its new drug product manufacturing facility in Shanghai Pilot Free Trade Zone has passed its first GMP inspection by the European Medical Products Agency (MPA). The new facility was opened at the end of 2018, and the successful inspection demonstrates the outstanding quality control system and rapid development of WuXi STA's drug product services.

In 2017, WuXi STA merged with WuXi AppTec's Pharmaceutical Development Services unit, realizing a seamless integration of chemistry, manufacturing and control (CMC) services. Two new commercial drug product facilities - in Shanghai and Wuxi City - have come into operation, enabling WuXi STA to support solid dosage drug development from preclinical to commercial stages, with several phase III and commercial drug product projects underway.

WuXi STA has received FDA inspections at both its API manufacturing facility in Jinshan (Shanghai) and API R&D & manufacturing facility in Changzhou. As a leading global Contract Development and Manufacturing Organization (CDMO), WuXi STA has passed inspections by regulatory bodies in the U.S., Canada, EU, Switzerland, China, Australia and New Zealand to supply APIs and GMP advanced intermediates for partners.

"We are very proud to have passed the European MPA GMP inspection," commented Ms. Mei Hao, Vice President of Quality at WuXi STA. "We will continue to strengthen our global quality control system to meet the most stringent regulatory requirements and ensure the quality of services to our partners worldwide. It is a key milestone in our efforts to build geographically integrated capabilities for both drug product and substance development and manufacturing."

"Quality is not just a core competency, it is ingrained throughout our culture at WuXi STA. The new facility passing the MPA's GMP inspection is a proof of our commitment to the highest possible quality standards. We look forward to empowering more customers to develop innovative drugs faster and more efficiently for the benefit of patients around the world," said Dr. Minzhang Chen, CEO of WuXi STA.

Formulation development#

WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement(2023年)

Eric_Xu — 2023-06-27T12:12:11+0900

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical, a biotechnology company, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal Pharmaceutical for GMP production, providing integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services from API to drug product.

Dizal Pharmaceutical is a research-based biotechnology joint venture company between AstraZeneca and Advanced Manufacturing Industry Investment Fund (FIIF) managed by private equity firm China Sate Development & Investment Corporation, dedicated to the discovery, development and commercialization of first-in-class/best-in-class medicines. Since its inception in October 2017, Dizal has worked closely with WuXi STA on CMC for an innovative drug.

Throughout this period, WuXi STA has provided process optimization, API manufacturing from grams to kilograms, drug product development and manufacturing for clinical trials, and IND filling in both China and USA. WuXi STA has utilized its innovative drug development and manufacturing platform, regulatory CMC support and quality systems to enable Dizal Pharmaceutical to successfully implement phase I clinical research in China and the USA.

The signing of the strategic cooperation agreement will further strengthen the deep and wide cooperation between the two companies. Dizal Pharmaceutical is currently leading several projects in the clinical development stage, covering physical and liquid tumors, chronic kidney disease, respiratory infections and other fields. In the future, WuXi STA will provide integrated CMC services from pre-clinical to commercial, for both API and formulation for Dizal Pharmaceutical research projects.

“We are delighted to sign a comprehensive strategic cooperation agreement with WuXi STA. The innovative capabilities and scale advantage of WuXi STA, as well as many excellent and experienced scientists will empower us to potentially accelerate our project pipelines. Ultimately, bringing new therapies to China and USA more quickly.” said Dr. Zhang Xiaolin, founder and CEO of Dizal Pharmaceutical.

Dr. Minzhang Chen, CEO of WuXi STA, commented: “Our mission is to empower customers to develop innovative drugs from clinical to commercial – faster and more efficiently. We are delighted to become the strategic partner of Dizal Pharmaceutical and look forward to helping them advance their drug candidates towards the clinic, bringing innovative medicines for the benefit of patients around the world.”

Formulation development#

WuXi STA Shanghai & Changzhou Facilities Pass U.S. FDA Inspections(2023年)

Eric_Xu — 2023-06-27T12:11:30+0900

SHANGHAI, 23 July, 2019: STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued. This not only marks a milestone for WuXi STA on running a continual state of regulatory readiness, with real time GMP monitoring and an ingrained internal quality culture, but also shows its commitment on providing integrated R&D and manufacturing services with the highest quality standard for customers.

“It’s a point of great pride that our quality systems allow us to be inspected at short notice by any applicable regulatory agency in the world. In this case, we received two separate inspection notices from FDA only seven days and five days in advance of the inspections, respectively. It’s an endorsement of the real time monitoring and quality culture we run across all parts of the company,” commented Ms. Mei Hao, Vice President of Quality at WuXi STA. “It’s another key example of the rigorous nature of our global standard quality systems. It is also another milestone for our platform, and in our efforts to have geographically integrated capabilities for both drug product and drug substance.”

WuXi STA has now successfully passed seven inspections from the U.S. FDA since 2013, producing branded drugs marketed in 95 countries. Its Analytical Service Unit provides clients with a full spectrum of analytical method development, validation and testing services from preclinical to commercial. The Changzhou facility with over 1,700,000 square feet has established a variety of new technology platforms such as spray dried dispersion, continuous processing (flow chemistry), oligonucleotides and peptides. It successfully completed the first U.S. FDA inspection in 2018.

"WuXi STA takes high priority on building quality system meeting global regulatory standards. These successful FDA inspections to ASU and Changzhou facility reflects WuXi STA's commitment to ‘quality first’. We will continue to enhance our platform with highest quality service to better enable our customers to bring better medicines faster for patients.” added Dr. Minzhang Chen, CEO of WuXi STA.

API manufacturer #

WuXi STA's Jinshan Facility Passes EMA Inspection(2023年)

Eric_Xu — 2023-06-27T12:10:52+0900

SHANGHAI, October 28, 2019: STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announced today that its Jinshan manufacturing facility in Shanghai, China has successfully passed an inspection by the European Medicines Agency (EMA) with no critical and no major findings. This demonstrates that as the trusted partner of global customers, WuXi STA can provide high quality GMP manufacturing services in compliance with global regulatory standards, to enable customers accelerate the development and manufacturing of new medicines for patients around the world.

“It's the first time that our Jinshan facility is audited by the EMA, with five auditors conducting a five-day inspection, spanning 11 products approved by the EMA in recent years. We continue to keep up a state of perpetual readiness across all our sites and actively welcome global regulators or client audits at any time. This is a direct testament to our organization’s culture of quality first, and real-time GMP monitoring.” commented Ms. Mei Hao, Vice President of Quality at WuXi STA.

This quality inspection approval marks a significant year for WuXi STA in exceeding global regulatory standards. In March, the company’s new drug product manufacturing facility in Shanghai Waigaoqiao passed its GMP inspection by the European Medical Products Agency (MPA), and in June, its Jinshan manufacturing facility passed a Pre-Approval Inspection (PAI) by Japan’s Pharmaceutical and Medical Device Agency (PMDA) for an innovative drug. Further, in July, WuXi STA’s Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou passed two inspections by the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.

“The successful EMA inspection at Jinshan is yet further proof of WuXi STA's commitment to enforcing the highest global quality systems. We will continue to pursue a ‘quality first’ commitment, constantly enhancing our platform with new services to enable our customers to bring better medicines to patients faster,” noted Dr. Minzhang Chen, CEO of WuXi STA.

WuXi STA has been engaged in new drug development and manufacturing for more than a decade, offering global partners efficient, flexible and high-quality solutions from preclinical to commercial uses with the integrated CMC (Chemical, Manufacturing, and Control) platform. More recently, WuXi STA expanded its platform to support oligonucleotides and peptides. The company has started construction of a new API process R&D center next to the current Jinshan site, adding 30,000 square meters of laboratories and more than 800 scientists. After completion, the Jinshan facility will become the second integrated site after Changzhou to support process R&D and manufacturing of innovative APIs for global partners. This year WuXi STA also initiated the third phase construction of a Changzhou API process development and manufacturing facility, which covers an additional 35 acres.

Formulation development#

Dr. Ge Li Awarded “CEO of the Year” at CPhI Worldwide 2019(2023年)

Eric_Xu — 2023-06-27T12:09:39+0900

November 11, 2019: WuXi AppTec, a leading global provider of R&D and manufacturing services enabling companies in the pharmaceutical, biotechnology and medical device industries, announced today that its Chairman and CEO Dr. Ge Li was awarded “CEO of the Year” at the CPhI Worldwide 2019, a top pharmaceutical event uniting over 45,000 professionals worldwide.

The 2019 CPhI Pharma Awards recognize the innovation and dedication of companies and individuals who are driving the pharmaceutical industry forward. Its Judging Panel is comprised of independent, senior industry experts from around the world, each chosen for their knowledge, objectivity and credibility.

Dr. Ge Li was chosen for his significant contribution to the global biopharma R&D industry. “Under his leadership, WuXi AppTec has become a highly respected contributor to global healthcare innovation. The company is enabling more than 3,700 customers and partners in more than 30 countries by offering open-access capabilities and services, accelerating the discovery and development of new medicines for patients around the world.”

“I’m honored by this award and its recognition of WuXi’s global platform,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “It’s been our great privilege to serve our innovative partners around the world and help bring some of the most needed medicines closer to patients

injectable formulation#

Dr. Ge Li Awarded “CEO of the Year” at CPhI Worldwide 2019(2023年)

Eric_Xu — 2023-06-27T12:09:02+0900

“I’m honored by this award and its recognition of WuXi’sglobal platform,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “It’s been our great privilege to serve our innovative partners around the world and help bring some of the most needed medicines closer to patients.”

Flow chemistry#

WuXi STA Forms Strategic Partnership with Impact Therapeutics(2023年)

Eric_Xu — 2023-06-27T12:07:43+0900

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Impact Therapeutics, a biotech focused on innovative drug discovery and development in anti-cancer therapeutics, announce the signing of a strategic partnership agreement. Under the terms of this agreement, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of Impact Therapeutics, providing services covering the entire product development process of Impact’s pipeline new drug candidates for both drug substance and drug product. The new partnership will accelerate Impact Therapeutics’ new pipeline drug development towards commercialization both in China and in the US.

Impact Therapeutics holds independent intellectual property rights for a diverse anti cancer therapeutics drug pipeline that includes PARP Inhibitors (IMP4297), Wee1 Inhibitors (IMP7068), DDR target Inhibitors and Hedgehog Pathway Inhibitors (IMP5471). Currently, IMP4297 is in Phase III clinical trials in China, with early clinical data targeting better safety and a wider treatment window.

On August 26, 2019, the government of China passed amendments to the Drug Administration Law, which will take effect on December 1, 2019. The revised Drug Administration Law adds a new chapter to better establish the Drug Marketing Authorization Holder (MAH) System including new evaluation and approval systems. The collaboration between innovative pharmaceutical companies and their CDMO partners in this context is vital to optimize the resource allocation and accelerate the new drug development process. Furthermore, the MAH system will strengthen drug regulation and improve drug quality and safety.

“We have formed an excellent partnership with WuXi STA over the last few years, and almost all of our pipeline molecules are developed in partnership using their comprehensive service platform. We chose WuXi STA to be our preferred CDMO partner because of their dedication as well as their world-leading integrated CMC (Chemistry, Manufacturing and Control) platform. This means they are able to expedite our products from clinical trial to commercial launch much faster.” said Dr. Jun Bao, President & CEO of Impact Therapeutics.

Dr. Minzhang Chen, CEO of WuXi STA, commented: “We are delighted to see the breakthroughs being made by Impact Therapeutics’ diverse pipeline. We are looking forward to further leveraging the scale and innovation capabilities at WuXi STA, along with our global standard quality systems to help our partners accelerate the process of launching new drugs to benefit global patients.”

Flow chemistry#

WuXi STA Opens Oligonucleotide Large-Scale Manufacturing Facility(2023年)

Eric_Xu — 2023-06-27T12:06:53+0900

Shanghai, January 3, 2020: STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – today announced the opening of its large-scale oligonucleotide active pharmaceutical ingredient (API) manufacturing facility in Changzhou, China. This significant milestone marks WuXi STA's establishment of a comprehensive one-stop platform to support the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial. It enables customers around the world to advance promising new oligonucleotide therapies more rapidly to market for the benefit of patients.

Nucleic acid drugs have gradually become a hot area in the global innovative drug industry and many nucleic acid drugs have been approved by the U.S. FDA in recent years. To help customers accelerate new drugs to market, WuXi STA is continuously strengthening its oligonucleotide platform. The new facility, with over 30,000 square feet, is located at WuXi STA’s Changzhou site. With its operation, the Changzhou site can manufacture oligonucleotide APIs up to 1 mol/synthesis run, to better meet the increasing demand of our customers.

WuXi STA's comprehensive platform covers the development and manufacturing of a variety of oligonucleotide modalities including DNA, RNA, Morpholino oligonucleotide (PMO) and peptide conjugates (PPMO). In addition, the company's industry-leading small molecule process chemistry organization adds further value in handling complex conjugation chemistry that involves oligonucleotide and other molecular modalities, as well as a combination of solid and solution phase chemistry to support next-generation oligonucleotide manufacturing technology development.

"By leveraging our small-molecule CMC (Chemical, Manufacturing, and Control) technology and capability platform as well as global standard quality system, WuXi STA provides a robust one-stop shop for oligonucleotide innovators. The opening of this large scale manufacturing facility will empower more global partners to expedite the development and commercialization of oligonucleotide drugs to benefit patients worldwide," commented Dr. Minzhang Chen, CEO of WuXi STA.

WuXi STA's Changzhou site can now provide services involving small molecule, oligonucleotide and peptide process R&D and manufacturing from laboratory to commercial scales. During the past years, it has successfully passed multiple inspections from the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA), adhering to the highest regulatory standards.

Formulation development#

WuXi STA Forms Strategic Partnership with BeiGene(2023年)

Eric_Xu — 2023-06-27T12:04:58+0900

Today, STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a leading biopharmaceutical company focusing on innovative, molecularly-targeted, and immuno-oncology drugs for the treatment of cancer, announced the signing of a strategic partnership agreement. Dr. Zhengming Du, Senior Vice President of BeiGene, Dr. Xiaoyong Fu, Senior Vice President for API Business of WuXi STA, and Dr. Jinling Chen, Vice President for Drug Product Business of WuXi STA attended the strategic cooperation signing ceremony.

Under the terms of this agreement, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of BeiGene, providing integrated CMC (Chemical, Manufacturing and Control) services for BeiGene's new drug pipeline projects from preclinical to commercial – including both drug substances and drug products.

Since 2011, WuXi STA and BeiGene have engaged in broad collaborations for drug substance and drug product development and manufacturing for many innovative drugs including BRUKINSA™ (Zanubrutinib). In 2015, WuXi STA started working with BRUKINSA™ project including process R&D and manufacturing of the API and drug product for clinical trial material. WuXi STA also supported the API process validation and the NDA submission of Zanubrutinib to U.S. FDA and to the China National Medical Products Administration (NMPA) for priority review. BRUKINSA™ received accelerated NDA approval for treatment of mantle cell lymphoma (MCL) from the U.S. FDA on November 15, 2019. On June 3, 2020 BRUKINSA™ was also approved by the China NMPA for treatment of relapsed refractory (R/R) MCL and R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The signing of the strategic cooperation agreement marks a new chapter between WuXi STA and BeiGene. In recent years, BeiGene has been expanding its pipeline with promising clinical programs, which will lead to increasing need for drug substance and drug product process R&D and manufacturing. With industry leading capabilities and expertise, WuXi STA will provide greater support for BeiGene to accelerate the development and commercialization of their pipeline drugs.

"Thanks to WuXi STA's outstanding contribution to the development and launch of many of our innovative new drugs. I am pleased to see the strengthened collaboration between our companies through this strategic agreement. We chose WuXi STA as our preferred CDMO partner because they can help us advance our pipeline molecules more efficiently with their CMC platform, and provide comprehensive support to the IND and NDA filings in both China and the US to benefit global patients." said Dr. Xiaobin Wu, general manager of China and president of BeiGene.

Dr. Minzhang Chen, CEO of WuXi STA, commented, "We are delighted to strengthen our strategic cooperation with BeiGene, and look forward to further leveraging the scale and innovation capabilities from our CMC platform. Along with our global standard quality systems, WuXi STA will work with BeiGene to develop more new drugs, from preclinical to commercial, faster and more efficiently to benefit patients around the world."

injectable formulation#

Tubulis Forms Strategic Partnership with WuXi STA and WuXi Biologics to Advance New Generation of Antibody-Drug Conjugates towards Clinical Evaluation(2023年)

Eric_Xu — 2023-06-27T12:04:05+0900

WuXi STA and WuXi Biologics to become Contract Development and Manufacturing Organization (CDMO) partners for Tubulis

MUNICH, GERMANY and SHANGHAI, CHINA, December 2, 2020 – Tubulis, WuXi STA and WuXi Biologics today announced a strategic collaboration to manufacture and advance Tubulis' next generation antibody-drug conjugates (ADCs) towards IND-enabling studies. Tubulis has developed a dual platform approach to generate uniquely matched and disease-specific ADCs that combine selective antibodies with effective payloads. This approach has demonstrated superior stability and efficacy in preclinical studies. The partnership with WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms and STA Pharmaceutical, a WuXi AppTec Company, (WuXi STA), will support the scale-up of the manufacturing process to a global clinical standard. The first program from Tubulis' pipeline the companies will collaborate on is TUB-010, a uniquely matched, highly stable and efficient protein-drug conjugate designed to treat patients with lymphoma.

Under the terms of the agreement, WuXi Biologics and WuXi STA will become the Contract Development and Manufacturing Organization (CDMO) partners for Tubulis. WuXi Biologics and WuXi STA will perform scale-up, process development and GMP manufacturing for the ADC product intermediates, with WuXi STA focused on the linker and payload and WuXi Biologics on the monoclonal antibody (mAb) and the enzyme used in Tubulis' proprietary Tub-tag® technology. WuXi Biologics subsequently will conduct process development and GMP bioconjugation to produce the drug substance and the final drug product formulation and fill for final preclinical toxicology studies. WuXi Biologics will also supply product batches for clinical evaluation. Financial details of the collaboration were not disclosed.

"As leaders in manufacturing for innovative technology platforms, WuXi Biologics and WuXi STA provide world-class capabilities for the development and production of our ADCs," said Dr. Dominik Schumacher, CEO of Tubulis. "For our uniquely versatile and customizable ADC technology portfolio, it was important to partner with CDMOs that have extensive experience with ADCs and offer the opportunity for a long-term partnership at the highest quality level. We are rapidly moving towards the clinic with our first ADC candidate and are excited to have entered this partnership, which will enable the further maturation of our pipeline."

"Tubulis requires single-source technology platforms, scientific expertise and state-of-the-art facilities set to the highest global quality standards. This is why we are thrilled to be selected for this project," remarked Dr. Chris Chen, CEO of WuXi Biologics. "This collaboration is a perfect illustration of the value that WuXi Biologics provides to innovative companies worldwide. Bioconjugates like TUB-010 are highly complex and require high levels of expertise and integration across the entire supply chain. We will leverage our advanced development platforms, large scientific teams dedicated to ADCs and industry-leading development timelines to bring TUB-010 towards the clinic."

"We are honored that Tubulis selected our organization to help bring this novel therapeutic towards the clinic with the goal of benefiting patients worldwide," commented Dr. Minzhang Chen, CEO of WuXi STA. "I am confident that WuXi STA's leading capability and capacity for high potency API, along with our high quality standards in meeting global regulatory requirements, will provide the strongest support for ADC linker and payload development and manufacturing. Our strong connection and past experience working with WuXi Biologics on ADC therapeutics, and our shared commitment to providing seamless project management and one-stop services, will ensure that together we can develop and manufacture TUB-010 efficiently."

Tubulis recently completed a €10.7 million Series A to expand the therapeutic potential of ADCs and to advance its uniquely versatile and customizable ADC technology portfolio. The company utilizes two proprietary technologies to tackle limitations of currently approved ADCs, which include stability and payload-driven toxicity. With the P5 conjugation, Tubulis employs a cysteine-selective conjugation that enables the generation of ultra-stable ADCs with unprecedented linker stability and chemical flexibility, enabling rapid lead identification. The second technology, the human-derived Tub-tag® platform, modulates the antibody to provide a highly beneficial microenvironment for the payload, thereby adding a significant amount of stability to the ADC. By tailoring the ADCs to the respective indication, Tubulis develops innovative compounds to treat cancer and beyond.

Formulation development#

WuXi STA's Integrated CMC Platform Supports InnoCare's Orelabrutinib Approved by NMPA(2023年)

Eric_Xu — 2023-06-27T11:53:58+0900

SHANGHAI, December 25, 2020: The National Medical Products Administration of China (NMPA) announced the approval of InnoCare's Orelabrutinib, which got the support from the STA Pharmaceutical, a WuXi AppTec Company (WuXi STA) . Under the Marketing Authorization Holder (MAH) policy, WuXi STA provided an integrated and end-to-end support including drug substance, amorphous solid dispersion, tablet and packaging for this product. Just a couple months ago, with four WuXi STA's sites inspected at the same time, WuXi STA successfully passed the pre-approval inspection (PAI) for Orelabrutinib from NMPA.

From September 15 to October 3 in 2020, this comprehensive 18-day PAI involved four WuXi STA's sites in China spanning drug substance manufacturing (Shanghai Jinshan), amorphous solid dispersions manufacturing using spray dried dispersion (SDD) (Changzhou), tablet manufacturing (Wuxi city), and drug substance process R&D, drug product R&D and clinical materials manufacturing (Shanghai Waigaoqiao). All of them successfully passed the inspection without major observations and key observations. As a critical success factor, WuXi STA's integrated quality system across all sites ensured streamlined process and efficient collaboration among different functional teams in different locations.

The success of this PAI also demonstrated a new high for WuXi STA's drug product platform. In the year of 2020 alone, the drug product platform had delivered over 1,200 clinical batches to the global customers. The NDA approval for Orelabrutinib once again proved its comprehensive capability from technology to quality. As a key technology of WuXi STA's bioavailability enhancing technology platform, SDD platform provides an end-to-end solution from preclinical R&D in tens of milligram scale to commercial manufacturing in metric ton scale, and now successfully supported Orelabrutinib launch.

InnoCare co-founder, chairman, and CEO Dr. Jasmine Cui said: "We are excited that Orelabrutinib was approved by NMPA. As our important partner of this innovative drug, WuXi STA has provided CMC support from clinical trials to commercialization, and successfully passed PAI for Orelabrutinib. We look forward to working with WuXi STA to address more unmet medical needs."

Dr. Minzhang Chen, CEO of WuXi STA, commented: "We sincerely congratulate our partner InnoCare on the approval of Orelabrutinib. The successful PAI is the result of close team collaboration between WuXi STA and our partner InnoCare. We will continue to leverage our industry-leading technical capabilities, along with our end-to-end CMC platform to empower our partners to accelerate their pathway to market for the benefit of global patients."

Formulation development#

WuXi STA, WuXi Biologics and Antengene Announce Collaboration to Advance Antibody-Drug Conjugate Candidate into Clinical Stage(2023年)

Eric_Xu — 2023-06-27T11:52:46+0900

Shanghai China, February 1, 2021— STA Pharmaceutical Co., Ltd., (“WuXi STA”) , a leading Contract Development and Manufacturing Organization, WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms and Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced a strategic collaboration to accelerate the development and manufacturing of antibody-drug conjugate (ADC) drug candidates in Antengen’s pipeline.

Antengene has invested in the ADC field for a long time, dedicating to discovery, development and commercialization of innovative therapeutics. Through this collaboration, WuXi STA and WuXi Biologics will provide services for the process development, scale-up, and GMP manufacturing of ADC drug intermediates. Antengene will focus on the discovery and development of monoclonal antibody, the core element of the ADC drug development. WuXi STA will focus on the GMP manufacturing of linkers and payloads while WuXi Biologics will provide process development for monoclonal antibody and the biological conjugation as well as the subsequent GMP manufacture. All three parties will work closely to leverage the resources and technological capabilities, with the goal to accelerating the development of ADCs for the benefit of patients.

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: “We are pleased to form a long-term strategic partnership with WuXi STA and WuXi Biologics. It has long been Antengene’s strategic imperative to establish our own in-house discovery capabilities, and we started our early discovery programs through the Antengene New Drug Discovery Center. Through strategic alliances and further integrating our clinical development, regulatory, and early discovery teams, we are rapidly advancing our in-house discovery programs. We believe that this collaboration will allow us to build an even stronger capabilities in ADC field by combining deep expertise from the three companies. I am confident that together we can bring our ADC pipeline forward much faster that will ultimately bring benefit to patients in need.”

Dr. Minzhang Chen, CEO of WuXi STA, commented: “We are delighted to strengthen our strategic cooperation with Antengene. I am confident that WuXi STA's leading capability and capacity for high potency API and conjugation chemistry for novel molecular modalities such as ADCs, along with our high quality standards in meeting global regulatory requirements, will provide the strongest support for ADC linker and payload development and manufacturing. We will continue to leverage our ‘end-to-end’ novel molecular modality platform to empower more partners to accelerate their development pathway to market for the benefit of global patients.”

Dr. Chris Chen, CEO of WuXi Biologics, said: “We are glad to expand our strategic collaboration with Antengene to advance its ADC program into clinical stage, leveraging our integrated biologics platforms, unparalleled capacity and world-class quality system. WuXi Biologics will continue to increase capabilities and capacities to enable global partners as they develop next-generation biologics such as ADCs for the benefit of patients worldwide. ”

Spray dried dispersion#

WuXi STA to Purchase Bristol Myers Squibb Manufacturing Facility in Couvet, Switzerland(2023年)

Eric_Xu — 2023-06-27T11:52:07+0900

NEW YORK & SHANGHAI -- Bristol Myers Squibb (NYSE: BMY) and WuXi STA – a subsidiary of WuXi AppTec – today announced that WuXi STA has agreed to purchase Bristol Myers Squibb’s manufacturing facility in Couvet, Switzerland. The Couvet site will be the first facility in Europe for WuXi STA, a leading Contract Development and Manufacturing Organization. The acquisition will enhance WuXi STA’s existing capabilities while growing capacity to support its partners’ life-saving work.

The companies anticipate completing the transaction by Q2 2021, subject to regulatory approvals and the satisfaction of other closing conditions. Upon closing, WuXi STA will acquire the Couvet site’s operations and assets, which include the plant and equipment, as well as a workforce with technical capabilities and expertise.

“The Couvet site is a world-class facility designed for quality, safety, and efficiency, and we believe WuXi STA will be able to leverage the capacity and capabilities for its own operations as it continues to play a vital role for patients around the world,” said Lou Schmukler, President, Global Product Development and Supply, Bristol Myers Squibb. “This is an important step in the ongoing evolution of our manufacturing network to support our product portfolio. Switzerland remains an important strategic location for Bristol Myers Squibb, and we look forward to maintaining a strong presence in the Neuchâtel area.”

“We are pleased to add the Couvet manufacturing facility to our growing global manufacturing site network and look forward to working with the talented team who share our focus on excellence and a patient-centered approach,” said Dr. Minzhang Chen, CEO of WuXi STA. “The acquisition will allow WuXi STA to better serve European markets and support our global customers to deliver innovative medicines and treatments to patients around the world.”

The Couvet facility will continue to operate as part of Bristol Myers Squibb’s manufacturing network until the closing of the transaction.

William Blair and Company, LLC, is serving as exclusive financial advisor to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

2021, WuXi STA Again Wins CMO Leadership Awards in All Six Core Categories(2023年)

Eric_Xu — 2023-06-27T11:49:39+0900

STA Pharmaceutical Co., Ltd., (“WuXi STA”) , a leading Contract Development and Manufacturing Organization, announces that it has received 2021 CMO Leadership Awards in all six core categories including Capabilities, Compatibility, Expertise, Quality, Reliability and Service. This is the seventh time that WuXi STA has won the “CMO Leadership Awards” and the second time being recognized in all six core categories, which fully recognizes the outstanding achievements and contributions by WuXi STA in building quality system meeting global regulatory standards and providing efficient, flexible and high-quality solutions with integrated CMC (Chemical, Manufacturing, and Control) services.

For the 2021 CMO Leadership Awards, Life Science Leader Magazine teamed up with Industry Standard Research (ISR) to conduct the Contract Manufacturing Quality Benchmarking survey that captured input from decision makers, aiming to recognize the top contract manufacturing organizations (CMOs) achieving outstanding performance in terms of capabilities, expertise, quality, etc., to set a benchmark in the industry. More than 70 contract manufacturers were assessed by 23 performance metrics in ISR's annual Contract Manufacturing Quality Benchmarking survey, covering all sizes of companies from both Pharma and Biopharma industries. In 2021, WuXi STA achieved the top overall honor in all six core categories based on customers’ direct experience and great feedback working with WuXi STA.

WuXi STA has been deeply involved in the CDMO industry for more than ten years. In the year of 2020 alone, WuXi STA served more than 470 customers worldwide, supporting 13 NDA approvals globally including 5 from US FDA, 4 from EU EMA, 2 from China NMPA and 2 from Japan PMDA. Dr. Minzhang Chen, CEO of WuXi STA, commented: “Thanks to our partners for their recognition of WuXi STA, and we will continue to leverage our end-to-end CMC platform, along with the global standard quality systems to empower more partners to accelerate their pathway to market for the benefit of global patients.”

Formulation development#

WuXi STA Forms Strategic Partnership with AnHeart to Accelerate the Development of Novel Oncology Therapies(2023年)

Eric_Xu — 2023-06-27T11:48:20+0900

SHANGHAI, CHINA, March, 15, 2021 –STA Pharmaceutical Co., Ltd., (“WuXi STA”), a leading Contract Development and Manufacturing Organization – and AnHeart Therapeutics (Hangzhou) Co., Ltd. (“AnHeart”), a clinical-stage oncology company focused on cancer patients in global markets, announced the signing of a strategic partnership agreement. Dr. Junyuan (Jerry) Wang, Chief Executive Officer at AnHeart, Bing Yan, MD, Chief Medical Officer at AnHeart, Dr. Xiaoyong Fu, Senior Vice President API Business at WuXi STA, and Dr. Jinling Chen, Senior Vice President Drug Product Business at WuXi STA attended the strategic cooperation signing ceremony.

Under the terms of this agreement, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of AnHeart, providing integrated CMC (Chemical, Manufacturing and Control) services for AnHeart 's pipeline projects including both drug substances and drug products, to accelerate its highly promising in-licensed programs from clinical to commercial, to enable these innovative oncology therapeutics benefit patients as soon as possible.

AnHeart has in-licensed three products since its establishment in 2018, and already advanced one of them, a next-generation ROS1/NTRK inhibitor, to the clinical stage. The lead clinical drug candidate Taletrectinib is a next-generation novel, potent, highly selective ROS1 and NTRK inhibitor that can cross the blood-brain barrier. AnHeart licensed the global rights of Taletrectinib from Daiichi Sankyo Company Limited (“DS”). Two phaseⅠ studies in the U.S. and Japan have been completed with promising safety and efficacy data, two clinical studies were approved in China in March 2020 for patients with NSCLC carrying ROS1 fusions and solid tumors with NTRK fusions. A phase Ⅱ trial of this compound is actively enrolling patients in China.

More and more companies are developing pipelines quickly through in-licensing programs. Risk assessment, partner selection, and reliable and efficient CMC work are the key factors to the success of these in-licensing programs. Under the MAH policy, Partnering with experienced CDMO has become the choice of many Chinese innovative pharma and biotech companies. WuXi STA has been well established in new drug development and manufacturing for more than ten years, leading the CDMO industry, especially strong in terms of late phase programs. In the year of 2020 alone, WuXi STA served more than 470 customers worldwide, including 45 phase III and 28 commercial drugs, and supported 10 new drugs approved in the US, Europe, Japan or China, bringing new treatment to the global patients.

With industry-leading capabilities and expertise, WuXi STA has the quality and technical advantages through many years of successful experience in the in-licensing programs, which will accelerate technical transfer, NDA approval and commercial manufacturing. With its integrated CMC platform, WuXi STA could carry out in-parallel operations including clinical manufacturing of API, drug product, analytical and CMC filing. Recently, WuXi STA has demonstrated its integrated CMC capability by completing the manufacturing of API, drug product and CMC filing support for phase III in less than 9 months. So the customer started the phase III clinical studies in China within 1 year from the project was licensed in.

“We are delighted to form a comprehensive strategic cooperation with WuXi STA,” said Junyuan (Jerry) Wang, PhD, Chief Executive Officer of AnHeart. “AnHeart is committed to quickly launching innovative therapeutics to help serve patients with unmet medical needs all over the world. Therefore, we need a CDMO partner with comprehensive capabilities, strong in quality system, EHS, technology, equipment, team, manufacturing capacity, etc., to expedite our products from clinical to commercial. WuXi STA has extensive experience and expertise with in-licensing programs, which will accelerate the pathway to market for patients. ”

Dr. Minzhang Chen, CEO of WuXi STA, commented: “We’re pleased to have a strategic partnership with AnHeart. AnHeart has licensed several highly promising projects to China to serve patients with unmet medical needs. We are looking forward to further leveraging our proven integrated CMC platform, along with our global standard quality systems established in the past decades, to help our partners accelerate their new drugs to market for the benefit of global patients.”

Three WuXi STA Facilities Pass Pre-Approval Inspection From NMPA(2023年)

Eric_Xu — 2023-06-27T11:47:36+0900

SHANGHAI, CHINA, April, 12, 2021 – STA Pharmaceutical, a WuXi AppTec company (WuXi STA), a leading contract development and manufacturing organization (CDMO) announces that three of its sites in China have successfully passed pre-approval inspections (PAI) by the China National Medical Products Administration (NMPA) concurrently for an innovative drug from its partner. Following a successful PAI for Orelabrutinib with 4 sites inspected simultaneously a few months ago, this PAI is another comprehensive inspection for its integrated chemical, manufacturing, and control (CMC) platform for both drug substance and drug product, which once again proved WuXi STA's industry-leading capabilities.

This comprehensive 13-day PAI involved three WuXi STA sites in China spanning drug substance process R&D (Changzhou), drug substance manufacturing (Shanghai Jinshan) and drug product R&D and manufacturing (Shanghai Waigaoqiao). During these 13 days, auditors conducted a comprehensive inspection of the development and manufacturing conditions for this innovative drug. All three sites successfully passed without major or key observations.

Since founded, quality has been WuXi STA's lifeline and code of conduct. To establish specific quality system or general quality management system, WuXi STA abides by the highest global standards to ensure the quality of services to its partners worldwide. At present, WuXi STA's quality system can support new drug applications in many countries and has successfully passed inspections from all major regulatory agencies including the US FDA, China NMPA, EU EMA and Japan PMDA. Received more than 200 client audits and 10 inspections from global agencies every year, WuXi STA keeps up a perpetual state of regulatory readiness, with real time GMP monitoring and an ingrained internal quality culture.

WuXi STA provides integrated and end-to-end CMC platform services to global partners. Currently, its pipeline carries more than 1300 new drug molecules, including 45 late-stage and 28 commercial projects. All sites of WuXi STA worldwide follow the same high quality EHS system to reduce risk, ensure quality and save time and cost for customers. The past PAI with four sites involved in 2020 and this three-site successful PAI are both direct result of this integrated quality system. In addition, the Marketing Authorization Holder (MAH) policy puts forward even higher requirements for quality system and product life cycle management. Following MAH, WuXi STA could start collaboration with customers at early development stage to ensure quality and compliance meet the needs of the product life cycle management.

Dr. Minzhang Chen, CEO of WuXi STA, commented: "I am very pleased that again we successfully passed PAI by the NMPA with multiple sites inspected at the same time. It is another track record for WuXi STA's CMC platform capability and quality system. With the highest global quality systems and an in-depth understanding of global regulations, we strive to provide the optimal solution for each project of our partners, bringing more innovative therapies to patients faster."

Spray dried dispersion#

WuXi STA Starts Construction of New Site in Taixing China(2023年)

Eric_Xu — 2023-06-27T11:46:37+0900

On April 28, 2021, STA Pharmaceutical, a WuXi AppTec company, announced the construction of its Taixing site officially started. Located in Taixing Economic Development Zone, Jiangsu China, Taixing campus will become another integrated API R&D and manufacturing site for WuXi STA, further strengthening its world-leading Chemistry, Manufacturing and Control (CMC) platform for innovative drugs, empowering more partners to launch more therapies faster.

With a total area of 170 acres, Taixing site is designed to support global partners with integrated API process R&D and manufacturing from preclinical to commercial stages. The first phase of the project, with an area of about 53 acres, is expected to be fully operational in 2025, with an annual capacity of more than 100 metric ton drug substance. The first phase of the project also includes industry-leading new molecular modality platforms from laboratory to commercial scale, such as high potency APIs, oligonucleotides and peptides. In addition, Taixing site reserved enough space for the second and third phases of the construction committed for future expansion.

Dr. Chen Minzhang, Chief Executive Officer of WuXi STA, commented, "leveraging the excellent local infrastructure and talent resource, Taixing site will further enhance our CDMO platform capability with even more capacities. With the continued development of our end-to-end CMC platform, I believe we can partner with more new drug innovators to bring novel therapies to patients worldwide faster.”

API manufacturer #

WuXi STA and WuXi Biologics Jointly Established WuXi XDC to Provide Fully Integrated Bioconjugate CDMO Services(2023年)

Eric_Xu — 2023-06-27T11:45:30+0900

Shanghai, CHINA, May 14, 2021 –WuXi STA, a subsidiary of WuXi AppTec and WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, today announced that a joint venture company named WuXi XDC was established to provide end-to-end contract development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs). Dr. Jimmy (Jincai) Li was appointed as CEO of WuXi XDC.

Per the terms of the joint venture agreement, WuXi Biologics and WuXi STA will make capital contributions of USD120 million and USD80 million respectively to WuXi XDC. WuXi XDC will be owned by WuXi Biologics for 60% and WuXi STA for 40%. Accordingly, WuXi XDC will become a non-wholly owned subsidiary of WuXi Biologics, providing services for development and manufacturing of antibodies or other biologics, chemical payloads and linkers, and the bioconjugated Drug Substance (DS) and Drug Product (DP).

Dr. Minzhang Chen, CEO of WuXi STA, commented: “Many ADC drug development companies face complex global supply chain and project management challenges with multiple contract partners to handle antibody, payload, linker and conjugations. In the past years, WuXi STA worked closely with WuXi Biologics on ADC therapeutics as well as other novel bioconjugates to provide our customers an expedited development pathway. Now with the initiative of WuXi XDC, we will further combine industry leading resources from both WuXi STA and WuXi Biologics, empowering more partners with a further optimized bioconjugates development and manufacture platform to launch their novel therapeutics faster to market for the benefit of global patients.”

“Bioconjugates have recently emerged as an exciting therapeutic modality to address unmet medical needs. We’re excited about establishing WuXi XDC, a dedicated end-to-end bioconjugate CDMO which will combine the world-class capacities and capabilities of both WuXi Biologics and WuXi STA to provide a superior one-stop service for global partners in an effort to expedite development and lower costs.” Dr. Chris Chen, CEO of WuXi Biologics and Chairman of WuXi XDC, commented, “We are also delighted to announce Jimmy’s new appointment and are confident that he will lead the company to establish a global outstanding bioconjugate CDMO to enable these novel therapeutics into the clinic and eventually on to commercialization.”

Dr. Jimmy Li, newly appointed CEO of WuXi XDC, commented, “I am very honored for the opportunity to lead WuXi XDC. By leveraging both the robust capacities and state-of-the-art technologies of WuXi Biologics and WuXi STA, WuXi XDC will further increase its unique presence in the bioconjugates industry to enable global partners as they build their innovative ideas into transformative new treatments for patients worldwide.”

Since 2014, over 80 different companies have worked with WuXi STA and/or WuXi Biologics – including 14 completed IND projects, and 1 program in phase III. Currently, WuXi STA and WuXi Biologics are managing more than 30 integrated ADC programs in the preclinical to late stage clinical continuum.

Formulation development#

WuXi STA Opens New Drug Product Facility in Wuxi City Site(2023年)

Eric_Xu — 2023-06-27T11:44:51+0900

Wuxi city, China, May 20, 2021- STA Pharmaceutical, a WuXi AppTec company, today announces the opening of a new R&D center in Wuxi city site. With the new facility in operation, the Wuxi city site now becomes the second integrated drug product R&D and manufacturing campus for WuXi STA, in addition to its Shanghai Waigaoqiao site.

The new R&D center in Wuxi city site, with the area of 118,400 square feet to house more than 500 scientists, includes oral dosage platform, sterile injectable platform as well as analytical testing platform. The oral dosage platform is equipped with wet granulation and roller compaction systems, capsule and tablet formulation equipment, coating and in process control R&D equipment, etc., to provide R&D support to projects from preclinical to commercial. The sterile injectable platform provides a variety of filling formats such as vial, prefilled syringe and cartridge. It can also handle freeze-drying process.

Currently, the Wuxi city site has two oral solid commercial-scale plants, to provide manufacturing, packaging and labeling services. In the third and fourth quarters of this year, a new oral solid dosage GMP manufacturing plant and the first sterile injectable GMP manufacturing line will start operation. Furthermore, various novel technology platforms, such as continuous manufacturing lines for oral solid formulation will be available by early 2022.

At the opening ceremony, WuXi STA also launched two unique drug product service packages: F2CS: Fast to Clinical Supply and F4CM: Fast for China Market. F2CS is designed to shorten the time it takes to develop formulation and deliver clinical trial material for Phase I studies, and F4CM is designed to shorten the time it takes to complete technical transfer, late phase development, and process validation in China market.

As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA is fully established in the drug product field, offering fully integrated drug product solutions, including solid state development, developability and formulation research, formulation development, and Clinical Trial Material (CTM) and commercial manufacturing in various oral and injectable dosage forms. WuXi STA also built a comprehensive bioavailability enhancement technology platform including spray dried dispersion (SDD), hot melt extrusion, nano suspension and softgel & liquid filled hard capsules. In 2020 alone, WuXi STA's successfully delivered over 1200 drug product batches to partners around the world. In addition, WuXi STA successfully supported the launch of InnoCare's Orelabrutinib in China market, providing end-to-end support including drug substance, amorphous solid dispersion, tablet and packaging for this product.

Dr. Minzhang Chen, CEO of WuXi STA, commented: “we are glad to launch the Wuxi city formulation R&D center to further enhance our drug product platform. We will continue to expand our end-to-end CMC platform from drug substance to drug product, along with the global quality systems, to enable our partners worldwide to deliver more effective and accessible advanced therapies to patients globally.”

Flow chemistry#

WuXi STA Forms Strategic Partnership with Ascentage Pharma(2023年)

Eric_Xu — 2023-06-27T11:44:09+0900

SHANGHAI, CHINA, June, 3, 2021 –STA Pharmaceutical Co., Ltd., (“WuXi STA”), a leading Contract Development and Manufacturing Organization – and Ascentage Pharma (6855.HK), announced the signing of a strategic partnership agreement. Under the terms of this agreement, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of Ascentage Pharma, providing integrated CMC (Chemical, Manufacturing and Control) services for Ascentage Pharma's projects in current and future pipeline, including the process development and manufacturing of both drug substances and drug products, regulatory support for IND filing and the following commercial manufacturing.

Ascentage Pharma is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and aging-related diseases. The collaboration between Ascentage Pharma and WuXi STA started in 2016. Due to the rapid progress made in multiple projects, both companies decided to establish a comprehensive partnership to cover the entire pipeline.

Ascentage Pharma remains committed to its global innovation strategy and has built a robust pipeline including eight clinical-stage and four preclinical-stage small-molecule drug candidates. The company has over 40 Phase I or Phase II ongoing clinical trials in the United States, Australia, Europe and China. Furthermore, Ascentage Pharma has obtained a total of 11 Orphan Drug Designations (ODDs) from the US FDA for 4 investigational drug candidates of the company.

As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA has industry-leading capabilities and expertise. In the year of 2020 alone, WuXi STA supported 10 new drugs approved globally, and is experienced in accelerating the development of Orphan, fast-track and breakthrough therapies. Under China’s (Marketing Authorization Holder) MAH policy, WuXi STA has successfully enabled a number of innovative drugs to launch in China, including Danoprevir, Fruquintinib, Zanubrutinib, Orelabrutinib, etc.

The signing of the strategic partnership agreement has further strengthened collaboration between Ascentage Pharma and WuXi STA. Leveraging the end-to-end CMC platform and proven quality systems, WuXi STA will provide Ascentage Pharma with flexible and high quality solutions for all projects at different stages.

Dr. Ming Guo, Co-Founder, President & Chief Operating Officer of Ascentage Pharma, commented, “Thanks to WuXi STA for their long-term support for Ascentage Pharma 's projects. The partnership between us are very fruitful. Ascentage Pharma has reached the inflection point in its expansion from R&D to manufacturing and commercialization, and we are very happy to expand the collaboration scope with WuXi STA at such an important stage. I believe that this strong alliance will accelerate our development pathway to market, and fulfill our mission of ‘addressing unmet clinical needs in China and around the world’ for the benefit of more patients.”

Dr. Minzhang Chen, CEO of WuXi STA, commented, “we are delighted to strengthen our partnership with Ascentage Pharma after many years of successful collaboration. This is another great example how WuXi STA’s end-to-end CMC platform empowered our partner. We are fully committed to accelerating the development and commercialization of Ascentage Pharma’s pipeline drugs to benefit patients around the world.”

Formulation development#

WuXi STA Forms Strategic Partnership with Coherent Biopharma(2023年)

Eric_Xu — 2023-06-27T11:40:37+0900

SHANGHAI, CHINA，WuXi STA – a subsidiary of WuXi AppTec– and Coherent Biopharma, announced the signing of a strategic partnership agreement.
According to the agreement, WuXi STA will become the preferred CDMO partner and provide Coherent Biopharma with integrated CMC services to accelerate its present and future drug candidates (small molecule, peptide, oligonucleotide and complex chemical conjugate, etc.), from API to drug product, including but not limited to the process development, manufacturing, analytical and regulatory filing support.
In recent years, Peptide Drug Conjugate (PDC) attracted attention from more and more pharmaceutical companies due to advantages such as strong tumor permeation, good scalability and relatively good pharmacokinetics etc. Coherent Biopharma is dedicated to R&D and commercialization of tumor-targeting ligand-mediated drugs and tumor markers. Based on independently developed BEST™(Bi-Engaging ligand-mediated Selective Targeting) technology platform, Coherent Biopharma has developed a diverse product pipeline with the PDC products, including CBP-1008 and CBP-1018, the two PDC drugs are both in clinical trials in the United States and China. Meanwhile, multiple new drugs are in various R&D stages, ready for clinical development in a few years.
Based on the prior successful collaboration on CBP-1008, this strategic partnership between Coherent Biopharma and WuXi STA is to broaden the collaboration beyond CBP-1008. PDC drugs has broad applications, but the development faces many technical challenges. WuXi STA has been deeply involved in the CDMO industry for more than twenty years, with its leading capability and capacity for small molecule, peptide, high potency API and complex conjugate such as PDC, it will provide a strong support for Coherent Biopharma PDC drug candidate development.
WuXi STA peptide platform provides comprehensive CRDMO (Contract Research, Development and Manufacturing Organization) services from drug discovery to commercial manufacturing. This vertically integrated peptide platform covers from unnatural amino acid, conjugate, peptide API to drug product, coupled with comprehensive analytical support and CMC writing services, supporting customers bring their peptide therapeutics to market faster. The unique peptide CRDMO platform will provide Coherent Biopharma with flexible and high quality solutions for all projects at different stages.
Dr. Baohua Huang, Chair and GM of Coherent Biopharma, commented, “We are very happy to enhance our partnership with WuXi STA to the next level, who is well known for its world-class scientific and technical strengths and industry leading end-to-end services, which offers great support to our PDC drugs. I am confident that our cooperation will accelerate the pathway of our cancer drugs to market for the benefit of global patients.”
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “We are pleased to form a strategic partnership with Coherent Biopharma. Coherent is one of the pioneers in the development of PDC drugs in China and has made great progress. We are looking forward to further leveraging our proven integrated CMC platform, along with our global standard quality systems, to accelerate Coherent's innovative drug development and ultimately benefit global patients.”

Formulation development#

Hoth Therapeutics Sign API and Drug Product Contracts with WuXi STA to Advance Manufacturing of HT-KIT(2023年)

Eric_Xu — 2023-06-27T11:39:57+0900

WuXi STA is a leading manufacturer of GMP morpholino oligonucleotides (PMOs)

NEW YORK, November 8, 2021 – Hoth Therapeutics, Inc., a patient focused biopharmaceutical company, announced today that it has entered into contracts with STA Pharmaceutical, a subsidiary of WuXi AppTec (WuXi STA), for process development and manufacturing of the active pharmaceutical ingredient (API) and formulation of drug product for the continued development and commercialization of HT-KIT. HT-KIT is a new molecular entity (NME) morpholino oligonucleotide therapy in development for targeting mast cell-derived cancers (aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)) and anaphylaxis.

These agreements between Hoth Therapeutics and WuXi STA are expected to accelerate the development of this new modality therapy with rapid and efficient PMO manufacturing scale-up from feasibility batches to GMP material. WuXi STA’s unique integrated CRDMO (Contract Research Development and Manufacturing Organization) new modality platform provides an end-to-end solution for oligonucleotide, peptide as well as their conjugates for both API and formulation under one roof.

The HT-KIT API process development for manufacturing is already underway, expecting to yield small-scale material in Q1 2022. Production of API will be immediately followed by initiation of formulation development for HT-KIT. Hoth intends to develop HT-KIT as a parenteral formulation for injection.

"Initiation of API and drug formulation development is a huge leap towards getting HT-KIT into clinical trials, which is a large focus for Hoth Therapeutics in the next year,” said Dr. Stefanie Johns, PhD, Chief Scientific Officer of Hoth Therapeutics. "We are confident in WuXi STA’s experience in manufacturing morpholino oligonucleotides for clinical and commercial applications to help expedite our program for HT-KIT."

"We are excited to collaborate with Hoth Therapeutics on this exciting next-generation therapy with far-reaching potential in oncology and beyond. This signing of this contract demonstrates our integrated new modality CRMDO platform is highly trusted by the customers. We are looking forward to accelerating this innovative therapy for the benefit of global patients." said Dr. Minzhang Chen, Co-CEO of WuXi AppTec.

After completion of formulation development, Hoth intends to pursue a Pre-IND meeting with the US FDA.

Biocatalysis#

WuXi STA Completes Acquisition of Bristol Myers Squibb Manufacturing Facility in Couvet, Switzerland(2023年)

Eric_Xu — 2023-06-27T11:39:17+0900

State-of-the-art facility significantly enhances WuXi STA's drug product capacity in Europe while better enabling global customers

New York & Shanghai, 3rd August, 2021: WuXi STA – a subsidiary of WuXi AppTec – today announced that it has completed the acquisition of a drug product manufacturing facility in Couvet, Switzerland from Bristol Myers Squibb (NYSE: BMY). WuXi STA first announced its plans to purchase the facility earlier this year. The acquisition will enhance WuXi STA's capabilities by adding capacity to support its global partners in bringing innovative medicines to patients around the world.

The Couvet site is the first facility in Europe for WuXi STA. Opened in 2018, this facility's state-of-the-art tablet & capsule manufacturing and packaging capabilities will provide WuXi STA's customers more flexibility thanks to an enhanced supply of global drug product and greater access to the European market and beyond.

By enhancing its network, WuXi STA can better support customers' long-term needs globally as they bring new and existing commercial manufacturing projects from their pipelines to the facility with the capability and capacity to supply drug products to major global markets.

"We are delighted to have added the Couvet site to our global supply network and are excited to welcome its highly skilled team to the WuXi STA family," said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. "Through combining resources of the Couvet site with our other facilities, we continue strengthening and broadening our capacity and capabilities to better support our global customers in delivering innovative medicines to patients in need."

Through this transaction, WuXi STA has increased its global presence to eight R&D and manufacturing sites across Asia, North America and Europe, including the recently announced Middletown site in Delaware of the United States.

Formulation development#

WuXi STA Forms Strategic Partnership with BioNova(2023年)

Eric_Xu — 2023-06-27T11:38:32+0900

STA Pharmaceutical Co., Ltd., a WuXi AppTec Company (WuXi STA)–and BioNova Pharmaceuticals (Shanghai) Ltd. ("BioNova") recently announced the signing of a collaboration agreement to jointly accelerate the development and manufacture processes for BioNova's innovative oncology medicines. Ye Hua, M.D. MPH, Founder, Chairman & CEO of BioNova, Steve Yang, Ph.D., Co-CEO of WuXi AppTec and Xiaoyong Fu, Ph.D., WuXi Chemistry CTO (Chief Technical Officer), and Head of API business attended the signing ceremony.

BioNova is a fast-growing biopharmaceutical company that is committed to developing and commercializing innovative medicines for cancer and other life-threatening diseases. The company pipeline is built on internal R&D programs, collaborations with, and acquisitions from partners of cutting-edge technology. BN101 (KD025) is one asset, originated by Kadmon Holdings (NYSE: KDMN) for which the two companies entered into a strategic partnership in 2019 to develop and commercialize for graft-versus-host disease (GVHD) in China. Currently, BioNova is conducting a Phase 2 BN101 clinical trial in China.

This strategic partnership between BioNova and WuXi STA is to broaden the collaboration beyond BN101. According to the agreement, WuXi STA will become the preferred CDMO partner and provide BioNova with integrated CMC services to accelerate its present and future drug candidates (small molecule, peptide, oligonucleotide and complex chemical conjugate, etc.), from drug substances to drug products, including but not limited to the process development, manufacturing, analytical and regulatory filing support.

Risk assessment, partner selection, and reliable and efficient CMC work are the key factors to the success of these in-licensing programs. With industry-leading capabilities and expertise, WuXi STA, through many years of successful experience in the in-licensing programs, has unique quality and technical advantages. WuXi STA's platform will enable BioNova to accelerate new drug innovation as well as localization for licensed-in products towards commercialization.

"We are delighted to establish this strategic collaboration with WuXi STA. As a leading CDMO company, WuXi STA is well known for its world-class scientific and technical strengths and expertise in the industry. With the support of industrial leading end-to-end service from WuXi STA, we look forward to expeditiously driving our development stage innovative drugs towards the clinic to fill the gap of unmet medical needs worldwide." said Ye Hua, M.D., Founder, Chairman & CEO of BioNova.

"It's an honor to become a strategic partner of BioNova. This collaboration once again demonstrates that our integrated CMC platform is highly trusted by the customers. We are looking forward to accelerating BioNova's innovative drug development and ultimately benefit global patients." said Dr. Minzhang Chen, Co-CEO of WuXi AppTec.

injectable formulation#

WuXi STA Forms Strategic Partnership with InnoCare(2023年)

Eric_Xu — 2023-06-27T11:37:55+0900

SHANGHAI, CHINA, July, 16, 2021 –STA Pharmaceutical Co., Ltd., a WuXi AppTec Company (WuXi STA)–and InnoCare Pharma Limited (HKEX: 09969), announced the signing of a strategic partnership agreement.

InnoCare Pharma 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. Currently InnoCare has developed a pipeline with over 10 innovative drugs in the field of cancer and autoimmune diseases, including one commercial-stage, five clinical-stage and several preclinical-stage drug candidates. In 2020, InnoCare's BTK inhibitor orelabrutinib was approved for two indications in China. As InnoCare's Contract Development and Manufacturing Organization (CDMO) partner, WuXi STA has supported the development and commercialization of orelabrutinib, providing API, amorphous solid dispersion, tablet manufacturing and packaging for this innovative drug. The signing of this strategic partnership agreement will enhance the partnership between the two companies.

Under the terms of this agreement, WuXi STA will become the preferred CDMO partner for InnoCare's current and future pipeline projects of small molecule, oligonucleotide, peptide and complex chemical conjugate, including but not limited to the API process development, manufacturing, analytical and regulatory filing support.

As a premier CDMO, WuXi STA established an industry leading integrated CMC platform with eight R&D and manufacturing sites globally, as well as a quality and EHS system meeting global standard. Under the strategic partnership agreement, WuXi STA will support InnoCare to accelerate the development of their pipeline drugs.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare, said, “We are very happy to enhance our partnership with WuXi STA, who has been our trusted partner for a long time. The collaboration between the two companies on the orelabrutinib project was very successful. InnoCare is committed to our core value of ‘Science Drives Innovation’, and has built up a strong new drug pipeline for the treatment of cancer and autoimmune diseases. We are dedicated to accelerating market entrance of our new drugs for the benefit of global patients.”

Dr. Minzhang Chen, CEO of WuXi STA, commented: “We are delighted to expand our partnership with InnoCare, which is another great example of how WuXi STA empowers our partners and earns their trust to support more projects in their pipeline. We are looking forward to leveraging our industry-leading capabilities and expertise, along with our well-established global standard quality system, to help accelerate the development and commercialization of InnoCare’s pipeline drugs to benefit patients around the world.”

Spray dried dispersion#

WuXi STA Chooses Middletown Delaware for New Pharmaceutical Manufacturing Campus(2023年)

Eric_Xu — 2023-06-27T11:37:16+0900

WuXi STA bringing about 500 jobs to Middletown

WILMINGTON, Del. (June 28, 2021) — WuXi STA and Delaware Prosperity Partnership today announced that WuXi STA, a leading Contract Development and Manufacturing Organization (CDMO), will build a new pharmaceutical manufacturing campus in Middletown, Delaware. The state-of-the-art WuXi STA Middletown Site, which is expected to open in 2024 and be its first on the East Coast, will be located at 1091 Industrial Drive in Middletown Business Center and aims to bring about 500 new full-time jobs to Delaware by 2026.

“This is an investment in good jobs that will drive economic growth in southern New Castle County and across Delaware,” said Governor John Carney. “I want to be the first to welcome WuXi STA to our great state. Over the next five years, WuXi STA plans to build a state-of-the-art pharmaceutical manufacturing campus in one of Delaware’s fastest-growing communities. This campus will build on our strength in biopharmaceuticals – and it’s only possible because of Delaware’s world-class, innovative workforce. Thank you to WuXi STA, Middletown Mayor Kenny Branner and everyone who made this project possible.”

“WuXi STA is excited to join Delaware’s growing healthcare community and establish Middletown as the home of our new state-of-the-art pharmaceutical clinical and commercial manufacturing complex,” said Minzhang Chen, CEO of WuXi STA. “Delaware’s highly trained pharmaceutical manufacturing workforce and proximity to many of our customers provide tremendous opportunities to support the region’s economic growth and efforts to advance pharmaceutical development and manufacturing. We are grateful to Delaware and Middletown for their leadership in fostering a strong entrepreneurial and innovation ecosystem, and we look forward to collaborating to deliver groundbreaking treatments for patients.”

There is growing industry and local customer demand for innovative technologies to help companies advance pharmaceutical discovery and development throughout the pre-clinical, clinical and manufacturing pipelines. As an industry-leading global CDMO, WuXi STA provides customers with one-stop manufacturing services for both drug substance and drug product, including oral and injectable dosage forms. The new facility in Middletown will feature space for testing laboratories; manufacture of active pharmaceutical ingredients (APIs); and manufacture and packaging of solid dosage pharmaceutical products and sterile products. Jobs at the site will include manufacturing operators, lab technicians, quality assurance and quality control staff, scientists and management, administrative and warehouse support staff. Supporting WuXi STA’s plans are grants that the company was approved to receive from the Delaware Strategic Fund by the state Council on Finance Development.

“This campus on 190 acres is going to add a tremendous diversity of good jobs to Middletown, New Castle County and Delaware as a whole. WuXi STA’s selection of Middletown reinforces what we do here, adds great value to what we have been working on for many years and shows us they have confidence in us, to want to be a part of what we have built here,” said Middletown Mayor Kenny Branner, who added he would like to thank the governor and the several state departments the town has been working with, especially Delaware Prosperity Partnership (DPP) and Kurt Foreman, president & CEO of DPP.

“We win the future by attracting global leading healthcare firms like WuXi STA to New Castle County,” said New Castle County Executive Matt Meyer. “This project will bring hundreds of good-paying jobs to the area and will advance New Castle County’s goal of growing our biotech industry. We welcome WuXi STA to New Castle County and look forward to its partnerships in Middletown and all across our community as it looks to fill jobs from our local and talented workforce.”

“Now in its fourth year of operation, the DPP team is proving that the public-private economic development model works well to leverage Delaware’s distinctive capacity to collaborate,” said Corporation Service Company President Rod Ward, who co-chairs DPP’s Board of Directors along with Governor John Carney. “The WuXi STA team worked through the DPP team with a host of partners, including the State of Delaware, the Town of Middletown, New Castle County, Delaware Technical and Community College, Chesapeake Utilities and many other regulatory and community partners.”

WuXi STA joins numerous other in companies choosing Middletown for growth in large-scale sites. The new facility will be near Middletown’s one million square-foot Amazon fulfillment center, as well as Datwyler Sealing Solutions’ 200,000 square-foot Middletown manufacturing plant and Breakthru Beverage’s new 285,000 square-foot headquarters.

WuXi STA currently provides pharmaceutical development and manufacturing solutions for over 470 partners worldwide, covering small molecules and novel molecular modalities such as oligonucleotide, peptide and various complex conjugates. The future Middletown site will become WuXi STA’s second site in the U.S., and will contain state-of-the-art pharmaceutical clinical and commercial manufacturing capabilities. The 190-acre campus will be home to WuXi STA's 8th global manufacturing facility.

WuXi STA’s current project plan is an initial phase for this new campus. Subsequent phases could further expand its campus in Middletown to a total workforce of more than 1,000 employees.

Formulation development#

WuXi STA Received 2020 CDMO Award from Roche(2023年)

Eric_Xu — 2023-06-27T11:34:45+0900

WuXi STA was announced as the winner of Roche's "2020 CDMO Award" for the best project-related performance of a CDMO in a given year.

The award ceremony was postponed to 2021 due to the pandemic and now was held both online and offline, Roche and WuXi STA leadership teams attended this ceremony with the project team members.

Dr. Thomas Osswald, head of external technical oversight at Roche, briefly reviewed the collaboration history with WuXi STA, especially the joint efforts for the IPP project, and praised WuXi STA as Roche's reliable, trustworthy partner. Dr. Xiaoyong Fu, CTO and head of API business at WuXi STA, and Dr. Youchu Wang, head of early stage API business at WuXi STA, recalled the milestone moments, with thanks to Roche for its trust over the past decades and expected a stronger future collaboration to bring more therapies faster to global patients.

The WuXi STA project team was recognized for the outstanding contributions to Roche's IPP[1] project, the HBV program, which started in 2014. WuXi STA became the first CMO in China for Roche to manufacture API for clinical supply in 2015. Since then, all teams, including process development, biocatalysis, and manufacturing etc., had made significant contributions to Roche's different projects. WuXi STA went above and beyond Roche's expectations by focusing on Roche's needs to overcome challenges and achieving technical breakthroughs in tight timelines.

WuXi STA's project teams and individual scientists received award from Roche, represented by Dr. Patrick Zheng, APAC regional category manager at Roche.

WuXi STA, a leader in the CDMO industry for twenty years, has supported 33 new drugs approved globally and products manufactured by WuXi STA have been launched in 105 countries around the world. In 2020 alone, WuXi STA served more than 470 customers worldwide. Moving forward, WuXi STA will continue to leverage its end-to-end CMC platform and industry leading technologies, along with the global standard quality systems to empower more partners to accelerate their medicines to market for the benefit of global patients.

[1] Internal code in Roche

Formulation development#

WuXi STA Passes the First U.S. FDA Drug Product Pre-Approval Inspection at its Shanghai Waigaoqiao Site(2023年)

Eric_Xu — 2023-06-27T11:34:06+0900

SHANGHAI, CHINA, January 4, 2022 – WuXi STA – a subsidiary of WuXi AppTec, announced that its Waigaoqiao site in Shanghai, China, successfully passed the first drug product pre-approval inspection (PAI) by the US FDA.

During the 5-day inspection from Oct. 22 - 26, 2021, the FDA inspector conducted a comprehensive onsite assessment including manufacturing facility and equipment, laboratories, quality management system, tablet production, material handling, computer control systems, and data integrity. Within the same week, the site also successfully passed two additional drug product PAIs by the China NMPA for two innovative drugs from its partners. Three successful drug product PAIs during one single week is a testimony to WuXi STA’s robust and reliable quality system.

WuXi STA’s drug product services at the Shanghai Waigaoqiao site include solid-state development, pre-formulation, formulation development, and clinical to commercial manufacturing for a broad range of oral dosage forms.

WuXi STA has passed over 40 inspections from all major regulatory agencies including US FDA, EMA, China NMPA and Japan PMDA. All eight sites across North America, Europe and Asia, follow the same quality system ensuring high-quality products manufactured for its partners worldwide. To date, WuXi STA has supported 34 new drug approvals globally. Products manufactured by WuXi STA have been launched in 105 countries around the world.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented: “I am very pleased that our drug product platform in Waigaoqiao has successfully passed its first PAI by the US FDA. It is another milestone that the site starts to provide commercial drug product manufacturing services to the US market. With our industry-leading global CMC platform and proven quality system, we strive to empower more partners to accelerate their innovative medicines to market for patients worldwide.”

Formulation development#

WuXi STA Launches its First Parenteral Formulation Manufacturing Line(2023年)

Eric_Xu — 2023-06-27T11:33:23+0900

Shanghai, China, January 21, 2022 - WuXi STA, a subsidiary of WuXi AppTec, today announced its first parenteral formulation manufacturing line at the Wuxi city site is now in commission. This wholly automatic sterile manufacturing line operates in a full isolation system with an annual capacity of 2 million units.

The industry-leading automatic parenteral filling line features multiple filling modules and a built-in lyophilizer to fill vials, syringes, and cartridges of a full range of sizes, as well as to produce lyophilized powders. Different filling modules can be switched rapidly, allowing for maximum flexibility and production efficiency.

This new parenteral formulation manufacturing line and the sterile manufacturing plant at Wuxi city site are designed per cGMP requirements by U.S. FDA, EMA, and China NMPA, equipped with the industry latest generation of isolation system and filling machine. The entire filling process is performed by robotics in a full isolation system, designed to minimize human interventions and eliminate contaminations to ensure high product quality.

WuXi STA's drug product platform covers a full range of services including solid-state development, pre-formulation, formulation development, and clinical to commercial drug product manufacturing for a broad range of oral and injectable dosage forms. In addition to the launch of this parenteral formulation manufacturing line, a second sterile filing line with an annual capacity of 10 million units is scheduled to start operation in Q3 this year at the same site.

With the addition of the sterile manufacturing line, WuXi STA's new modality CRDMO platform provides an end-to-end solution for oligonucleotides, peptides as well as complex conjugates from API to drug product, from discovery to commercial manufacturing.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "I am glad that our first fully automatic parenteral formulation manufacturing line has been launched in the Wuxi city site. WuXi STA will continue to build first-class facilities with cutting-edge technologies. We strive to provide our global partners the most advanced, customized, flexible solutions to accelerate drug development to bring more innovative medicines to market for patients worldwide."

Spray dried dispersion#

WuXi STA Wins 2022 CMO Leadership Awards in All Six Core Categories(2023年)

Eric_Xu — 2023-06-27T11:32:41+0900

Shanghai, China, February 8, 2022 - WuXi STA, a subsidiary of WuXi AppTec, today announced that it received 2022 CMO Leadership Awards in all six core categories including Capabilities, Compatibility, Expertise, Quality, Reliability and Service and scored as a 2022 CMO Leadership Award Champion in four core categories. It is the eighth year that WuXi STA has been selected as an award-winner and the third consecutive year recognized in all six core categories.

For the 2022 CMO Leadership Awards, Life Science Leader Magazine teamed up with Industry Standard Research (ISR) to conduct the Contract Manufacturing Quality Benchmarking survey that captured input from decision makers, aiming to recognize the top contract manufacturing organizations (CMOs) achieving outstanding performance in terms of capabilities, expertise, quality, etc.. More than 86 contract manufacturers were assessed by 23 performance metrics in ISR's annual Contract Manufacturing Quality Benchmarking survey, covering all sizes of companies from both Pharma and Biopharma industries. With outstanding performance over the past year, WuXi STA won a 2022 CMO Leadership Award in all six core categories and scored as a 2022 CMO Leadership Award Champion in four core categories, based on customers' direct experience working with WuXi STA.

Dedicated to the CDMO industry for twenty years, WuXi STA served more than 560 customers worldwide in the year of 2021 alone. There are over 1,500 molecules in WuXi STA's pipeline, including 49 late-phase projects and 42 commercial projects. With the industry-leading integrated CMC platform and the global quality system, products manufactured by WuXi STA have been launched in 105 countries around the world.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "It is a great honor for WuXi STA to receive the CMO Leadership Awards in all six categories again. Thanks to our partners for their recognition and trust. WuXi STA will continue to leverage our integrated CMC platform empowering more partners to accelerate the development of their innovative medicines for patients worldwide."

Flow chemistry#

WuXi STA and Hua Medicine Sign Supply Agreement for Dorzagliatin(2023年)

Eric_Xu — 2023-06-27T11:31:55+0900

SHANGHAI, CHINA, WuXi STA – a subsidiary of WuXi AppTec– and Hua Medicine (SEHK stock code: 2552.HK) today announced signing a supply agreement for the commercial manufacturing of dorzagliatin, a first-in-class oral therapy for type 2 diabetes (T2D). This commercial supply agreement between Hua Medicine and WuXi STA will further enhance their current collaboration. As the long-time trusted partner of Hua Medicine, WuXi STA will provide the commercial supply of dorzagliatin, helping millions of people with diabetes in China.

Hua Medicine is a leading innovative biotechnology company in China focusing on novel therapy development for diseases with unmet medical needs. It was announced in April last year that the New Drug Application (NDA) of dorzagliatin, a first-in-class glucokinase activator (GKA), was accepted by China National Medical Products Administration (NMPA). The phase III clinical study of dorzagliatin monotherapy showed 65.2% diabetes remission rate without the intervention of any glucose-lowering medication in 52 weeks, after the patients reached the normal glucose level with dorzagliatin treatment. With this positive result, dorzagliatin provides a new option of oral treatment for T2D patients.

WuXi STA was the 1st CDMO that Hua Medicine ever worked with and remains a preferred partner. For dorzagliatin, the two companies worked closely for API and solid dispersion process development and manufacturing, accelerating the first-in-class oral antidiabetic therapy to market. Last year, dorzagliatin has successfully passed the Pre-approval Inspection (PAI) by NMPA at the Shanghai Waigaoqiao site and Changzhou site of WuXi STA. With the agreement signed, Hua Medicine and WuXi STA will continue their close collaboration for API and solid dispersion R&D and commercial manufacturing.

Additionally, WuXi STA received the "Most Valuable Partner" award by Hua Medicine in recognition of its long-term contribution to the dorzagliatin project.

Dr. Li Chen, CEO of Hua Medicine, said, "WuXi STA proved to be an important partner for us during our 10-year collaboration. Going forward, we expect a closer relationship with WuXi STA in the commercial manufacturing of dorzagliatin to reach more T2D patients in China, thus addressing this major public health issue."

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "We are pleased to enhance our partnership with Hua Medicine for dorzagliatin. We look forward to leveraging our proven integrated CMC platform, global standard quality system, and vast API and solid dispersion commercial manufacturing capacity to accelerate the commercialization of dorzagliatin for diabetic patients."

Formulation development#

WuXi STA Forms Strategic Partnership with Xynomic Pharma(2023年)

Eric_Xu — 2023-06-27T11:30:55+0900

SHANGHAI, CHINA, WuXi STA – a subsidiary of WuXi AppTec– and Xynomic Pharmaceuticals (Nanjing) Co., Ltd. (“Xynomic”) announced the signing of a strategic partnership agreement.

According to the agreement, WuXi STA becomes the preferred CDMO partner providing Xynomic integrated CMC services to accelerate its present and future drug candidates (small molecule, peptide, oligonucleotide and complex chemical conjugate, etc.), from API to drug product, including but not limited to the process development, manufacturing, analytical and regulatory filing support.

Xynomic Pharmaceuticals (Nanjing) Co., Ltd. is a global biopharmaceutical company that is committed to developing and commercializing innovative medicines for oncology. Their pipeline is built on both internal R&D and license-in programs, including three clinical-stage and two preclinical-stage small-molecule drug candidates. Xynomic owns global exclusive right for development and manufacturing of their entire pipeline. The lead drug candidate abexinostat has successfully completed the dosing of the first-phase patients in its on-going China phase 2 clinical trial, as a third-line therapy against relapsed or refractory follicular lymphoma. The preliminary data shows excellent result and now the team is preparing NDA filing documents to China NMPA. The collaboration with WuXi STA will speed up the global commercialization of Xynomic.

Currently, WuXi STA is the CDMO partner of Xynomic for the API and tablet R&D, manufacturing and packaging of abexinostat. With the agreement signed, WuXi STA will further support the New Drug Application (NDA) filing in both the US and China and global commercial manufacturing for this product. The signing of this strategic partnership agreement proved the enhanced collaboration between the two companies.

Deeply involved in the CDMO industry for twenty years, WuXi STA has established an integrated CMC platform with global standard quality systems. It has supported 33 new drugs approved globally and products manufactured by WuXi STA have been launched in 105 countries around the world. With industry-leading capabilities and expertise, WuXi STA has the quality and technical advantages through many years of successful experience in the in-licensing programs, which will accelerate technical transfer, global NDA approval and commercial manufacturing.

Mr. Y. Mark Xu, Chairman and CEO of Xynomic, commented, “We are delighted to form a comprehensive strategic cooperation with WuXi STA. Xynomic is currently simultaneously advancing multiple new drugs, and we are very happy to expand the collaboration scope with WuXi STA at such an important stage. WuXi STA has world-class scientific and technical strengths and industry leading capability and capacity, and I believe that this strong alliance will further accelerate the development of our innovative drugs, especially abexinostat, to benefit patients around the world.”

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “We are pleased to enhance our partnership with Xynomic for all the drug candidates in its pipeline, which once again demonstrates how WuXi STA’s end-to-end CMC platform empowered our partner. We look forward to leveraging our proven integrated CMC platform, along with our global standard quality systems, to accelerate the development and commercialization of Xynomic’s pipeline drugs for the benefit of global patients.”

Formulation development#

WuXi STA Passes the First EMA Drug Product Pre-Approval Inspection at its Wuxi City Site(2023年)

Eric_Xu — 2023-06-27T11:27:56+0900

SHANGHAI, CHINA, March, 3, 2022 –WuXi STA – a subsidiary of WuXi AppTec – today announced that its drug product facility in Wuxi City, China has successfully passed its first pre-approval inspection (PAI) and received the GMP Compliance Certificate from the European Medicines Agency (EMA).

The PAI focused on the drug product manufacturing of an innovative drug for one of WuXi STA's partners. During a 5-day remote inspection from November 8 to 12 in 2021, the inspector assessed the compliance of the manufacturing operations against the EU Guideline to Good Manufacturing Practice (GMP). The inspection included a comprehensive review of the quality management system, the manufacturing & QC equipment and facilities, tablet manufacturing operations and controls, material handling and data management & integrity programs. The PAI was completed successfully with no critical or major observations, and the Wuxi City site will start provide commercial drug product manufacturing service of this innovative medicine for the European market.

WuXi STA's drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms. In 2020, the site passed PAI from China NMPA and this latest successful PAI from the EMA further demonstrates the company's robust and reliable quality system.

High quality standard is embedded in WuXi STA's core value. Since its initial founding, WuXi STA has passed over 50 inspections from all major regulatory agencies including US FDA, EMA, China NMPA, SwissMedic and Japan PMDA. With the industry-leading integrated CMC platform and the global quality system, products manufactured by WuXi STA have been launched in 105 countries around the world.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "I am very pleased that after our Shanghai Waigaoqiao site passed its first drug product PAI by the US FDA last year, our Wuxi City site has also successfully passed its first drug product PAI from the EMA. We will continue to maintain the highest global quality standards and through our global R&D and manufacturing network, empower more partners to accelerate the development of their innovative medicines for patients worldwide."

Formulation development#

WuXi STA Opens Another High-Potency API Plant in Changzhou, China(2023年)

Eric_Xu — 2023-06-27T11:27:17+0900

Shanghai, China – June 24, 2022 – WuXi STA, a WuXi AppTec company, has opened another high-potency API (HPAPI) plant at its Changzhou site (Jiangsu, China). The new plant is added to meet the growing demand for high-potency API process R&D and manufacturing services.
The new HP plant consists of reactors from 250 L to 3,000 L, prep-HPLC systems, a 10 m2 tray lyophilizer, as well as flow chemistry and milling technologies. The new plant adopts advanced isolation technologies with the capability to handle potent compounds with Occupational Exposure Limit (OEL) as low as 10 ng/m3.
Currently, WuXi STA has two sites located in Shanghai Jinshan and Changzhou, China to support the process development and manufacture of high-potency active pharmaceutical ingredients. These two facilities are equipped with multiple HP process R&D and analytical labs, kilo labs, and three plants along with various process technologies such as prep-HPLC, milling, flow chemistry etc., providing customers a dual supply chain to meet their HPAPI needs from preclinical to commercial. In addition to HP API, WuXi STA's Changzhou site is capable of handling the process development and manufacturing services for linkers, oligonucleotides, and peptides, providing a unique "one-stop" flexible and efficient solution to companies developing therapies made of various complex conjugate modalities.
As an industry-leading CRDMO service provider, WuXi STA is committed to continuously adding new capabilities and capacities to our global network to support our global partners by accelerating more innovative therapies to patients worldwide.

Formulation development#

WuXi STA Opens New Large-scale Oligonucleotide and Peptide Manufacturing Facility(2023年)

Eric_Xu — 2023-06-27T11:26:36+0900

Site Enhances New Modality CRDMO Platform Capacity for Customers

Shanghai, China, July 7, 2022 - WuXi STA, a subsidiary of WuXi AppTec, today announced the opening of a new large-scale oligonucleotide and peptide manufacturing facility at its Changzhou campus. The new facility underscores WuXi STA's ongoing commitment to enhance its capacity and capability to meet the fast-growing customer needs for oligonucleotide and peptide therapeutics development and manufacturing worldwide, making more innovative therapies accessible to the patients.

With the opening of the new 30,570 sq.ft. oligonucleotide plant, WuXi STA extends its leadership in oligonucleotide development and manufacturing worldwide, with four large-scale oligonucleotide production lines and more than 20 small- to mid-scale production lines that increase the overall manufacturing capacity of a single synthesis run from 1.9 mol to 6.0 mol.

The new 22,260 sq.ft. peptide plant features three new production lines with reactors that can accommodate up to 1,000 L, increasing WuXi STA's overall Solid Phase Peptide Synthesis (SPPS) total reactor volume to 6,490 L.

The new facility is an essential part of WuXi STA's comprehensive end-to-end Contract Research, Development, and Manufacturing Organization (CRDMO) platform for new modalities. The platform supports oligonucleotides and peptides, including novel monomers and linkers, and complex conjugates, from early discovery to development and commercial production at any scale. With this enhanced manufacturing capacity and over 850 dedicated scientists, WuXi STA's new modality CRDMO platform can better enable global partners as their projects progress to late and commercial stages.

In addition, WuXi STA offers injectable formulation development and manufacturing services, including Lipid NanoParticle technology (LNP), as well as comprehensive analytical and Chemical, Manufacturing, and Controls (CMC) dossier preparation services, which further accelerate the development of new oligonucleotide and peptide therapeutics for the market.

"We are pleased to support our global partners in their efforts to develop new modality therapies for patients in need," said Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA. "WuXi STA is committed to enabling partners by enhancing our new modality CRDMO platform's capacity and capability to expedite the development and commercialization of more innovative therapies to benefit patients worldwide."

WuXi STA has a global network of multiple R&D and manufacturing sites across Asia, North America and Europe, including a new pharmaceutical manufacturing campus in Middletown, Delaware that is scheduled to open in 2024.

injectable formulation#

WuXi STA Opens a New Large Scale Continuous Manufacturing Plant at Changzhou Site(2023年)

Eric_Xu — 2023-06-27T11:25:56+0900

Company continues to enhance the flow chemistry platform for more sustainable production

Shanghai, China, July 15, 2022 - WuXi STA, a subsidiary of WuXi AppTec, today announced that it has opened a new continuous manufacturing (flow chemistry) plant at its Changzhou campus in China for large-scale active pharmaceutical ingredient (API) and advanced intermediate production. This new expansion marks the company's continuous effort to enhance its flow chemistry platform in response to the increasing customer demand for safe and sustainable pharmaceutical manufacturing.

The new plant features 11 continuous production lines which support 20 types of challenging reactions, including low temperature metallo-organic reactions, photochemical reactions, high-temperature & high-pressure reactions, nitration reactions, ozonolysis, etc. With the opening of the new plant, WuXi STA now has multiple flow chemistry R&D labs and 25 continuous manufacturing lines in Shanghai Waigaoqiao, Shanghai Jinshan, and Changzhou sites in China.

Committed to process safety and sustainability, WuXi STA started building its flow chemistry capability in 2014. To date, WuXi STA has supported over 500 continuous manufacturing projects, including more than 20 late-stage and commercial projects.

"We are witnessing a fast-growing customer demand driven by the extensive application of flow chemistry in the pharmaceutical industry," said Dr. Xiaoyong Fu, CTO and Head of API Business at WuXi STA. "As a trusted partner and a global enabler, we will continue to strengthen our flow chemistry platform and accelerate new therapeutics with safer and more cost-effective solutions to benefit patients in need while reducing the environmental impact of large-scale manufacturing."

API manufacturer #

WuXi AppTec Plans to Build a New Site in Singapore, Better Serving Global Partners and Advancing Healthcare Innovation(2023年)

Eric_Xu — 2023-06-27T11:25:17+0900

SINGAPORE, July 19, 2022 – WuXi AppTec, a leading global provider of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry, today announced a plan to build a new R&D and manufacturing site in Singapore. The company intends to invest up to S$2 billion (approximately US$1.43 billion) to construct and operationalize the site, which aims to further enable global partners to advance healthcare innovations. The investment is expected to be made in stages over the next 10 years, depending on the company's business needs.

The new site will further expand the capacity and enhance the capabilities of WuXi AppTec's integrated enabling platform and will yield state-of-the-art laboratories and facilities that provide a broad portfolio of R&D and manufacturing services to customers worldwide.

When completed, the Singapore site will serve a critical role in WuXi AppTec's global network across Asia, Europe, and North America, meeting growing demand from multinational customers and strengthening collaborations with a wide range of partners. Together, and through their unique CRDMO (Contract Research, Development and Manufacturing Organization) and CTDMO (Contract Testing, Development and Manufacturing Organization) business models, these facilities will provide a range of high-quality services with greater flexibility, allowing the company to better help partners worldwide advance drug discoveries and development and deliver groundbreaking treatments to patients in need.

"We warmly welcome WuXi AppTec's plan," said Dr. Beh Swan Gin, Chairman of the Singapore Economic Development Board (EDB). "The investment will establish Singapore as a significant node in the company's global research, development and manufacturing network. It is a testament to Singapore's position as a global biopharmaceutical hub, and will strengthen our attractiveness to biotech innovators and start-ups."

"We are excited to establish this important presence for WuXi AppTec in Singapore and continue to contribute to the region's dynamic life sciences ecosystem," said Dr. Ge Li, Chairman and CEO of WuXi AppTec. "This investment will further enhance our capacity and capabilities so we can better support our collaborative partners globally and realize our shared vision that every drug can be made, and every disease can be treated."

Spray dried dispersion#

WuXi STA Breaks Ground for New Pharmaceutical Manufacturing Facility in Middletown, Delaware(2023年)

Eric_Xu — 2023-06-27T11:24:35+0900

MIDDLETOWN, Delaware, August 16, 2022 – WuXi STA, a leading Contract Research, Development, and Manufacturing Organization (CRDMO), is pleased to announce the groundbreaking for its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware. First announced in June 2021, this site will be WuXi STA's second facility in the United States, offering expanded capacity and greater flexibility to meet the needs of customers in the U.S. and around the world.

The WuXi STA Middletown site is located in the Middletown Business Center at 1091 Industrial Drive, and the new state-of-the-art facility will create approximately 500 full-time jobs by 2026. Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labeling, storage and distribution services for clinical trial materials and commercial drug products.

WuXi STA has 12 sites across the U.S., Europe and Asia that offer a range of services and meet or exceed all regulatory standards. Together with three other drug product manufacturing sites in Couvet (Switzerland), Wuxi City (China) and Shanghai (China), this new facility will further enhance the company's global drug production capacity and capabilities.

"The biopharmaceutical industry is part of Delaware's DNA," said Delaware Governor John Carney. "Over the next five years, WuXi STA plans to build a state-of-the-art pharmaceutical manufacturing campus in one of Delaware's fastest-growing communities, bringing with it good jobs and economic growth. This campus is only possible because of Delaware's world-class, innovative workforce. Thank you to WuXi STA, Middletown Mayor Kenny Branner and everyone who made this project possible."

"The First State continues to be a first-rate destination for businesses looking to innovate and grow," said Senator Tom Carper. "This investment by WuXi STA helps position Delaware as a continued global leader in biopharmaceuticals, further cementing the manufacturing might of one of our fastest growing communities. Delaware's workforce is ready to help build the future of our life-saving pharmaceuticals. This state-of-the-art campus will create good jobs and help fortify our supply chains here at home."

"This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region" said Senator Chris Coons. "I am excited about WuXi STA's decision to choose Middletown for one of their new manufacturing facilities. This isn't just the largest private-sector investment in Middletown's history – it's a defining moment that will bring many more good-paying jobs to Delaware and will further cement the First State as a world leader in biopharmaceutical research and manufacturing. Thanks are due to everyone from Middletown to Dover to Washington who helped us get to this point, whether by making continued investments in NIIMBL, improving our education system from kindergarten to our universities, or ensuring that Delaware workers have the skills manufacturers like WuXi AppTec are looking for."

"As the First State, Delaware has always had a spirit of innovation – constantly seeking new opportunities and ventures that will strengthen our economy and our state as a whole," said Rep. Lisa Blunt Rochester. "Today's groundbreaking of the WuXi STA pharmaceutical manufacturing plant represents another step in that spirit of innovation – bringing good-paying jobs to Middletown and strengthening communities throughout Delaware. The state-of-the-art facility will bring 500 full-time jobs over the next several years, growing our state's workforce and allowing us to manufacture more goods domestically – enhancing our economic competitiveness on the global stage."

"We are truly looking forward to our partnership with WuXi STA, as the groundbreaking today marks the kick-off to them making their new home in Middletown, Delaware. WuXi STA will be joining our bustling industrial area, just steps away from Clarios, Datwyler, Amazon and Breakthru Beverage, just some of the companies that have invested in Middletown. When asked by WuXi STA about our business-friendly attitude, these businesses expressed their wholehearted support for how we do business and we couldn't be more excited about WuXi STA wanting to join them, and the Town of Middletown, in our journey together," said Middletown Mayor Ken Branner. Branner added he was thankful for the support of Gov. John Carney and the Delaware Prosperity Partnership.

"I would like to thank our federal, state and local partners in Delaware for their continued support in the establishment of this site," said Dr. Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA. "WuXi STA continues to increase our capabilities and capacities to better serve our customers through a more robust and reliable supply chain. With our integrated Contract Research, Development, and Manufacturing Organization (CRDMO) platform and proven quality system, we look forward to working with our customers to swiftly deliver their innovative therapies to market in order to save lives and improve healthcare for patients."

The WuXi STA Middletown facility is expected to begin operations in 2025.

Formulation development#

WuXi STA Launches Another Parenteral Formulation Manufacturing Line at Wuxi City Site(2023年)

Eric_Xu — 2023-06-27T11:21:42+0900

Shanghai, China, November 30, 2022 – WuXi STA, a subsidiary of WuXi AppTec, today announced a new parenteral formulation manufacturing line has started operation at the drug product site in Wuxi city, China. It is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units. This expansion demonstrates the company’s continuous commitment to enhance its injectable drug product platform.
This new line features a fully automatic vial loading/unloading system and a built-in 15 ㎡ lyophilizer in a fully enclosed isolator. The filling line supports vials in a full range of sizes for solutions and lyophilized powder while allowing rapid switches between modes for maximum filling flexibility and efficiency. The filling speed can reach 200 vials per minute, significantly accelerating large-volume parental drug product production speed. This facility is designed per global cGMP standards, equipped with state-of-the-art containment system and advanced filling machine. From vial cleaning, drying, filling to freeze-drying, the entire process is wholly automated in the isolator to ensure high product quality with minimal human interventions.
Located in Jiangsu, China, the Wuxi city site is an integrated drug product R&D and manufacturing campus with the comprehensive analytical platform for both oral and injectable formulations. The site has passed Pre-Approval Inspections from both European Medicines Agency (EMA) and China National Medical Products Administration (NMPA), sharing the same proven quality system across all sites within WuXi STA. The injectable platform at the site supports all synthetic modalities including small molecules, oligonucleotides, peptides and complex conjugates. With the advanced sterile lipid nanoparticle (LNP) facility at Wuxi city, the site is well positioned to provide formulation development and manufacturing for oligonucleotides and the conjugates.
To continue enhancing the injectable platform capabilities, a high potency (HP) parenteral formulation manufacturing line is slated to begin operations in Q3 2023 at Wuxi city site. In addition, injectable formulation development and manufacturing services will be available from the company’s new site at Middletown Delaware US in 2025, further enhancing the platform capability and capacity for global customers.
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "I am glad that our parenteral drug product capacity has been expanded to meet the growing demands. WuXi STA is committed to strengthening our integrated CMC platform and building first-in-class facilities with cutting-edge technologies. We strive to provide our global partners with flexible, fast, and cost-efficient solutions to accelerate new therapies to market for patients worldwide."

WuXi STA Opens a New Clinical Supply Service Facility at Shanghai Waigaoqiao Site(2023年)

Eric_Xu — 2023-06-27T11:21:06+0900

New service further accelerates drug candidates to clinical trials through CRDMO platform
Shanghai, China, September 30, 2022 - WuXi STA, a WuXi AppTec company, today celebrated the inauguration of a new Clinical Supply Service (CSS) facility at the Shanghai Waigaoqiao site to accelerate drug candidates to clinical trials for its global customers. With the new facility in operation, WuXi STA further expands its CRDMO platform to include API and drug product development, manufacturing, packaging, labeling and distribution from preclinical to commercial phase.

The new CSS facility is designed to accommodate a wide range of storage and packaging conditions and provides complete clinical supply lifecycle management service to support global clinical trials. The CSS service covers primary and secondary packaging design, label design and printing, packaging and labeling, storage and distribution, including cold chain logistics, clinical distribution, as well as clinical trial material (CTM) return and destruction in China.

In addition, WuXi STA's proven quality system in API, drug product, analytical, and CSS allows a seamless transition of CTM from CMC to CSS project management within one quality team to ensure a fast, flexible, and reliable clinical supply solution to support global customers.

As an industry-leading Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA has 12 sites across North America, Europe, and Asia. The opening of the new CSS facility demonstrated WuXi STA's ongoing effort to expand its CRDMO platform to better support its global partners.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, noted: "WuXi STA is committed to enabling our global customers with an integrated CRDMO platform, and we never stop expanding this platform with new capacity and capability. With the inauguration of our new Clinical Supply Service facility in Shanghai, we look forward to supporting our customers accelerate their innovative therapies to market for patients worldwide."

Formulation development#

WuXi STA Successfully Passes Four Pre-Approval Inspections by South Korea's Ministry of Food and Drug Safety at Three Manufacturing Sites in China(2023年)

Eric_Xu — 2023-06-27T11:20:15+0900

SHANGHAI, CHINA, October 12, 2022 – WuXi STA, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that its three manufacturing sites in China have successfully passed four remote pre-approval inspections (PAI) by South Korea's Ministry of Food and Drug Safety (MFDS).

Within four weeks, the MFDS completed four PAIs for three innovative drugs, including two API manufacturing inspections at the Changzhou site, one API manufacturing inspection at the Shanghai Jinshan site, and one drug product manufacturing inspection at the Shanghai Waigaoqiao site.

The successful completion of four inspections is another testimony to WuXi STA's high global quality standard across all sites in Asia, North America, and Europe. To date, WuXi STA has passed over 50 inspections from all major regulatory agencies, including US FDA, EMA, China NMPA, SwissMedic, and Japan PMDA. With the integrated CRDMO platform and the global standard quality system, WuXi STA has supported 36 new drug approvals since 2017 and the products WuXi STA manufactured have been launched in 105 countries around the world.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "I am pleased to see that our manufacturing sites successfully passed four pre-approval inspections by MFDS within a month. As a CRDMO committed to empowering more global partners, WuXi STA will maintain the highest global quality standard and strengthen our global R&D and manufacturing network to accelerate more innovative medicines for patients worldwide."

Spray dried dispersion#

WuXi STA Opens First High Potency Oral Drug Product Manufacturing Facility(2023年)

Eric_Xu — 2023-06-27T11:18:39+0900

New facility expands integrated drug product R&D and manufacturing services to global customers

Shanghai, September 26, 2022 – WuXi STA, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the opening of its first high potency (HP) oral drug product manufacturing facility at its Wuxi city campus. This new facility marks a milestone for WuXi STA to further extend its drug product capacity and capabilities to meet the growing demand for HP drug candidate development and manufacturing services.

With this new facility, WuXi STA is well positioned to provide an integrated R&D and manufacturing network for high potency active pharmaceutical ingredients (HPAPI) and drug product from preclinical to commercial manufacturing. Specifically, this facility will complement the services and offerings of WuXi STA's existing HPAPI facilities in Changzhou and Shanghai Jinshan, which are near Wuxi city. Furthermore, WuXi STA is slated to open a new HP sterile parenteral production plant in Q3 2023 at the WuXi campus.

The containment performance target (CPT) of this new HP oral drug manufacturing facility meets the control requirements of occupational exposure limit (OEL) as low as nanogram per cubic meter level. The facility offers multiple formulation processes, including wet and dry granulation, tablet compression and coating, as well as capsule filling, with an annual production capacity of 400 million tablets and 200 million capsules.

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "We are delighted to announce the opening of our first drug product manufacturing facility for high potency oral products. As our global partners and customers seek accelerated pathways for new drug development, WuXi STA is committed to further enhancing our integrated platform to enable more healthcare breakthroughs that benefit patients worldwide."

In recent years, WuXi STA has established new state-of-the-art facilities to increase the company's drug production capacity and capabilities to meet the needs of customers around the world. In August, the company announced the groundbreaking for its new pharmaceutical manufacturing campus in Middletown, Delaware, which will provide formulation development and clinical and commercial drug product manufacturing services in phase I. Last year, WuXi STA established its first Europe-based drug product manufacturing facility in Couvet, Switzerland, which provides tablet & capsule commercial manufacturing and packaging capabilities.

Flow chemistry#

WuXi STA Opens a New Sterile Lipid Nanoparticle Formulation Facility to Enhance Global CRDMO Services for Customers(2023年)

Eric_Xu — 2023-06-27T11:12:12+0900

Shanghai, China, September 9, 2022 – WuXi STA, a subsidiary of WuXi AppTec, today announced the opening of a new sterile lipid nanoparticle (LNP) formulation development and manufacturing facility at its Wuxi city campus. Created in response to the increasing demand for complex injection dosage forms, this new facility marks the company's fast-growing parenteral formulation capabilities and is yet another opportunity to enable customers as they develop and deliver better medicines for patients.
This new facility integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform, offering significant advantages in drug-loading, liposome particle size control, and encapsulation efficiency. In addition, the modular design provides greater processing flexibility, enabling this platform to serve a wide range of manufacturing scales from 10-50 L per batch.
As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA's integrated drug product platform offers a full spectrum of services, including solid-state development, pre-formulation, formulation development, and clinical to commercial drug product manufacturing with a variety of drug delivery technologies, including a broad range of oral and injectable dosage forms. This new sterile LNP platform further expands our end-to-end capabilities.
WuXi STA has 12 sites across the U.S., Europe and Asia that offer a wide range of services and meet global regulatory standards. Together with other development and manufacturing sites, this new platform provides considerable synergy with the company's oligonucleotide CRDMO platform. The LNP delivery system is particularly advantageous in overcoming the bioavailability challenge of oligonucleotides and their conjugates.
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "We are pleased to support our partners with this state-of-the-art LNP facility to meet the growing demand for advanced injection dosage forms. We will continue to expand our CRDMO platform's capacity and capabilities to enable our partners to accelerate more innovative drugs to market for patients worldwide."

injectable formulation#

WuXi STA Forms Strategic Partnership with Insilico Medicine(2023年)

Eric_Xu — 2023-06-27T11:08:32+0900

SHANGHAI, CHINA, September 1, 2022 – WuXi STA, a subsidiary of WuXi AppTec, and Insilico Medicine, a global clinical-stage artificial intelligence-driven drug discovery and development company, today announced a strategic partnership for the integrated CMC services.

Insilico Medicine owned more than 30 pipelines under development, covering various diseases, including cancers, fibrosis, immunity, central nervous system diseases, and aging-associated diseases. Insilico's leading anti-fibrosis drug candidate, ISM001-055, is undergoing phase 1 clinical trials in both New Zealand and China. The collaboration between WuXi STA and Insilico started in 2021, while WuXi STA provided the end-to-end CMC service, including both API and formulation development and manufacturing for ISM001-055.

As the leading CRDMO, WuXi STA has supported 35 new drugs approved globally since 2017, and the products manufactured have been launched in 105 countries. This strategic partnership is to broaden the collaboration between WuXi STA and Insilico beyond ISM001-055. Under this agreement, WuXi STA will be the preferred contract research, development, and manufacturing organization (CRDMO) partner and will provide integrated end-to-end CMC solutions to Insilico's current and future drug discovery and development projects. The services include but are not limited to API and drug product research, development, manufacturing, and regulatory CMC dossier preparation services.

Alex Zhavoronkov, Ph.D., founder and CEO of Insilico Medicine, commented: "We are excited to have WuXi STA's end-to-end CMC platform supporting our projects. The past collaboration was fruitful, and I believe this collaboration expansion will greatly accelerate our pipelines to the market and fulfill the patients' demand around the world."

Dr. Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA, commented: "We are pleased to enhance our partnership with Insilico. We will continue building our integrated CRDMO platform and look forward to empowering more breakthroughs to benefit patients worldwide."

Formulation development#

WuXi STA and Multiply Labs announce partnership and successfully deploy robotic manufacturing system for personalized drugs(2023年)

Eric_Xu — 2023-06-26T23:24:07+0900

Personalized doses now can be filled into single - or multi - compartment capsules for GMP manufacturing

Shanghai, China, December 1, 2022 - WuXi STA, a subsidiary of WuXi AppTec and a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced the partnership with Multiply Labs (based in San Francisco, CA, USA), a robotics company that has developed industry-leading automated manufacturing systems to produce individualized drugs.

The focus of the partnership is to enable the manufacturing of personalized drugs for patients. Within this collaboration, Multiply Labs has deployed a novel robotic system in WuXi STA's facilities that efficiently produces advanced solid oral dosage forms, including capsules containing personalized dosage strengths of a single API (e.g., for modified release) and capsules containing personalized combinations of multiple APIs and their formulations. This robotic technology targets a broad range of GMP manufacturing applications, including the production of personalized drug products for specific patient groups (e.g., pediatric/geriatric populations and rare disease patients) and the combination of multiple drugs in one single capsule (e.g., for personalized combination therapies).

Personalized dosing applications – from clinical to commercial manufacturing – have traditionally been very challenging and labor - intensive. Truly personalized manufacturing is limited by the inflexibility of traditional manufacturing technologies, which are only able to generate one large batch each time. The WuXi STA - Multiply Labs partnership addresses these challenges through the unique combination of robotic technology and drug product manufacturing expertise.

As part of the partnership, Multiply Labs has completed the deployment of a robotic system in WuXi STA's drug product manufacturing site in Wuxi city, China. The manufacturing applications of the robotic system focuses on the development and GMP manufacturing of capsules with personalized doses.

This technology can manufacture virtually any type of capsules, and even capsule configurations that are difficult with traditional technologies. The robots have been designed to handle personalized deposition for most common formulations, including powders, powder blends, granules, beads, and minitabs. The system can be preprogrammed to manufacture personalized product batches - for example, different dosage strengths for different patients, different release profiles for better therapeutic effects, dosage form flexibility such as minitabs vs granule, etc., giving customers the enhanced flexibility. In addition to traditional capsules, this robotic system can also manufacture multi-compartment capsules, which are ideal for drug combinations where two or more APIs or formulations need to be compartmentalized.

"WuXi STA is a globally recognized leader in the formulation development and manufacturing, and Multiply Labs is excited to partner with them in bringing our pioneering robotic technology to the market," said Fred Parietti, Ph.D., Co-founder, and CEO of Multiply Labs. "Our joint teams have collaborated at an unprecedented speed to develop and deploy this unique technology. Our goal is to enable precision medicine to scale and reach all the patients who need it, and this breakthrough partnership is an exciting step forward towards that vision."

"We believe that automation is the future of pharmaceutical manufacturing," said Jinling Chen, Ph.D., SVP and Head of Pharmaceutical Development and Manufacturing Services at WuXi STA. "By bringing together Multiply Labs' novel robotic technology and WuXi STA's industry-leading drug product development and manufacturing expertise, we can better support customers to accelerate their drug product development by enabling more personalized dosing for clinical studies."

Three Sites from WuXi STA Receive Top EcoVadis Scores for Business Sustainability Rating(2023年)

Eric_Xu — 2023-06-26T23:23:38+0900

WuXi STA, a subsidiary of WuXi AppTec, received the latest scores from EcoVadis rating, a trusted provider of business sustainability ratings, for active pharmaceutical ingredients (API) R&D and manufacturing from its Changzhou site, and for formulation development and manufacturing from its Shanghai Waigaoqiao site and Wuxi city site, respectively. All three China sites received scores of 60+ with a "Silver" rating from EcoVadis, powering the company to a leading position in the industry.

The sustainability audits of WuXi STA's three sites were performed in November 2022 from four dimensions: environment, labor and human rights, ethics, and sustainability procurement. The scores reflect the company's sustainability achievements and continued commitments from different functional departments and management systems to the Environmental, Social and Governance (ESG) compliance.

EcoVadis, a trusted business sustainability rating provider, has rated more than 100,000 companies across 200+ industries and 175+ countries. Through the rating scorecards, EcoVadis provides benchmarks for rated companies in their industry to drive global supply chain sustainability and encourage industry-wide competence to achieve better global practice and continuous improvement.

Since its initial founding, sustainability has been the cornerstone of WuXi AppTec's business. As an enabler of innovation, a trusted partner, and a global contributor, WuXi AppTec recognizes its role in fulfilling business sustainability and social responsibility. The dedicated efforts have resulted in the first-ever inclusion in the S&P DJSI (S&P Dow Jones Sustainability Emerging Markets Index) in 2021 and an "AA" rating for a second consecutive year from MSCI (Morgan Stanley Capital International) ESG ratings in 2022. In addition, the Corporate received a "Strong" management score by Sustainalytics the same year, ranking in the top 2% in the global pharmaceutical industry with a "Low Risk" rating. As a core contributor to WuXi AppTec's ESG strategy, WuXi STA has integrated the Corporate' ESG initiatives into every aspect of management and daily operations.

"As a responsible corporate citizen working closely with our suppliers and partners to reduce environmental impact, we are committed to reaching all the targets we released in our recent ESG report," said Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA. "We will continue to apply ESG principles and initiatives to our daily work while enabling more new therapies to market for patients worldwide."