合全药业上海金山原料药生产基地通过欧洲EMA现场检查

中国上海，2019年10月28日--药明康德子公司合全药业宣布其位于上海金山的原料药生产基地顺利通过欧洲药品管理局（European Medicines Agency，EMA）的现场检查。这再次印证合全药业作为深受全球客户信赖的合作伙伴，能够提供符合国际质量标准的GMP生产服务，赋能客户加速推动新药上市进程，造福广大病患。

“这是合全金山基地接受的第一次EMA检查，5位检察官开展了为期5天的检查，范围包括了EMA近年来批准的11个产品。此次顺利通过检查，再次表明合全已具备成熟的质量管理体系和审计接待能力，可以常态化接受全球监管机构的检查。”合全药业质量保证副总裁郝玫女士表示。

2019年，合全药业在构建符合国际标准的质量体系方面取得诸多进展。3月，外高桥新制剂生产基地首次通过欧盟药品管理局（European Medical Products Agency，MPA）GMP认证；6月，金山基地首次通过日本医药品医疗器械综合机构（Pharmaceuticals and Medical Devices Agency，PMDA）检查；7月，常州基地和外高桥分析服务中心再次通过美国食品药品监督管理局（Food and Drug Administration，FDA）检查。

“此次金山基地顺利通过欧洲EMA检查，再次证明了合全拥有符合国际标准的质量体系。我们会一如既往地坚持‘质量第一’ 的原则，通过提供高效、灵活的一体化解决方案，赋能全球合作伙伴，加速其新药上市的进程。” 合全药业首席执行官陈民章博士表示。

合全药业深耕创新药的研发与生产十余年，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。近年来，合全更不断把研发和生产能力从小分子延伸到寡核苷酸和多肽等新型药物。在平台规模的建设上，合全药业近几年也取得了令业界瞩目的成绩：比邻金山基地，全新的合全药业原料药研发中心将投入使用，增加3万平方米的研发实验室和800多名科研人员。落成后，金山基地将会成为继常州基地之后，合全第二个能为全球合作伙伴提供原料药从研发到生产一体化解决方案的基地。此外，合全药业常州原料药研发和生产基地也在2019年启动了建设占地面积达211亩的常州基地三期工程，这将进一步巩固合全药业一体化平台的规模和能力优势，为全球合作伙伴提供更高质量的服务。

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）的领军企业，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

关于药明康德

药明康德（股票代码：603259.SH/2359.HK）为全球生物医药行业提供全方位、一体化的新药研发和生产服务。通过赋能全球制药、生物科技和医疗器械公司，药明康德致力于推动新药研发进程，为患者带来突破性的诊疗方案。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比和高效的研发服务，助力客户提升研发效率，服务范围涵盖化学药研发和生产、细胞及基因疗法研发生产、医疗器械测试等领域。目前，药明康德的赋能平台正承载着来自全球30多个国家的3600多家合作伙伴的研发创新项目，致力于将更多新药、好药带给全球病患，早日实现“让天下没有难做的药，难治的病”的梦想。更多信息，请访问公司网站：www.wuxiapptec.com

WuXi STA’s Jinshan Facility Passes EMA Inspection

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.  

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

About WuXi AppTec

WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,600 collaborators from over 30 countries to improve the health of those in need – and to fulfill our dream that "every drug can be made and every disease can be treated." Please visit: http://www.wuxiapptec.com