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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.”