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.”
About BeiGene
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 3,800+ employees in China, the United States, Australia, and Europe are committed to expediting the development of a diverse pipeline of novel therapeutics for cancer. We currently market two internally-discovered oncology products: BTK inhibitor BRUKINSA™ (zanubrutinib) in the United States, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com
About WuXi STA
WuXi STA, a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: https://sta.wuxiapptec.com/
