写意发布 ｜ 合全药业与百济神州签署战略合作协议
2020年6月5日，药明康德子公司合全药业宣布与专注于分子靶向和免疫肿瘤疗法的领军企业百济神州签署战略合作协议。百济神州高级副总裁杜争鸣博士、合全药业原料药业务高级副总裁傅小勇博士和制剂业务副总裁陈金玲博士等共同出席了签约仪式。
合全药业原料药业务高级副总裁傅小勇博士（图左）与百济神州高级副总裁杜争鸣博士（图右）合影
根据合作协议，合全药业将成为百济神州在CDMO（合作研究开发生产）领域的首选合作伙伴，为其新药研发管线项目提供从临床前到商业化， 包括原料药和制剂的一体化CMC（化学、生产和控制）服务。
自2011年始，合全药业和百济神州在原料药和制剂研发、生产等领域展开全方位、多层次的合作，覆盖包括泽布替尼胶囊（英文通用名zanubrutinib；中文商品名：百悦泽®；英文商品名：BRUKINSA™）等在内的多个创新药研发管线。2015年，合全药业开始为泽布替尼提供原料药早期及关键临床批、制剂早期临床批工艺研究和生产，之后合作延续到原料药后期研究、工艺验证等，再到成功协助百济神州加快新药申请的提交。该创新药已于2019年11月15日（北京时间）获得美国FDA加速批准上市，并成为首个获得FDA四大特殊通道资格认定的中国自主研发抗癌新药。令人欣喜的是，就在2020年6月3日，泽布替尼胶囊正式获中国国家药品监督管理局批准上市，用于既往至少接受过一种治疗的成人套细胞淋巴瘤（MCL）患者和既往至少接受过一种治疗的成人慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者，标志着首个国产布鲁顿氏酪氨酸激酶（BTK）抑制剂问世。
此次达成战略合作，标志着双方的紧密合作迈入新篇章。百济神州近年来多管线并进，临床进展势头良好，随着项目推进将会面临大量临床后期及商业化的研发及生产需求，合全药业深耕CDMO领域，积累了丰富经验及强大实力，将为百济神州加快和促进新药研发提供有力支持。
百济神州总裁兼中国区总经理吴晓滨博士表示：“感谢合全药业长期以来对推进我们多个创新药的临床研究和上市所付出的突出贡献，非常高兴双方能够通过此次战略合作的签署进一步加强合作。我们非常需要合全这样的平台和合作伙伴，帮助我们更高效地推进项目管线，并在新药IND及NDA在中美两国申报上给予全面、专业的支持，以期为病患带来福音。“
合全药业首席执行官陈民章博士表示：“我们很高兴与百济神州在多年合作的基础上进一步深化战略合作，合全期待利用自身十多年来打造的一体化CMC平台的规模优势和创新能力，以及符合全球标准的质量体系，赋能百济神州更多管线新药的研发，加速商业化进程，为全球范围内的患者谋求福音。”
关于百济神州
百济神州是一家全球性、商业阶段的生物科技公司，专注于研究、开发、生产以及商业化创新性药物以为全世界患者提高疗效和药品可及性。百济神州目前在中国大陆、美国、澳大利亚和欧洲拥有3800多名员工，正在加速推动公司多元化的新型癌症疗法药物管线。目前，百济神州两款自主研发的药物，BTK抑制剂BRUKINSA™（泽布替尼）和抗PD1抗体药物百泽安®（替雷利珠单抗注射液）分别在美国和中国进行销售。此外，百济神州在中国正在或计划销售多款由安进公司、新基物流有限公司（隶属百时美施贵宝公司）以及 EUSA Pharma 授权的肿瘤药物。欲了解更多信息，请访问 www.beigene.cn
关于合全药业
合全药业是在中美两地均有运营的药明康德子公司，服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合作研究开发生产领域（CDMO）领军企业，合全药业致力于为全球合作伙伴提供从临床前到商业化，高效、灵活、高质量的一站式CMC（化学、生产和控制）解决方案。更多信息请访问公司网站：www.STApharma.com.cn
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
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with operations in China and the United States. 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: http://www.STApharma.com