药明生物四个生产厂和生物药安全检测中心的十个生物药项目再次获得欧洲药品管理局GMP认证

中国无锡、苏州

2024年8月1日

全球领先的合同研究、开发和生产（CRDMO）服务公司药明生物（WuXi Biologics, 2269.HK）宣布，其位于无锡的四个生物药原液厂和生物药制剂厂，以及苏州检测中心再次获得欧洲药品管理局（EMA）的GMP认证，彰显公司恪守国际行业质量标准，为全球客户提供高品质服务的坚定承诺。

此次药明生物位于无锡的生物药原液一厂（MFG1）、生物药原液二厂（MFG2）、生物药原液五厂（MFG5）和生物药制剂一厂（DP1）成功通过了欧盟EMA针对公司为客户生产的八款处于商业化和新药上市申请（NDA）阶段药品开展的全面检查，肯定了药明生物为全球客户提供相关服务的实力与能力。这些生物药生产厂此前曾多次获得包括EMA在内的国际主要监管机构认证。此外，药明生物苏州检测中心也再次获得EMA针对十款创新药品的GMP认证，其中包括前述八款创新药。

药明生物一流的质量标准体系屡获验证。2017年至今，药明生物已成功通过全球主要药品监管机构的35次检查，通过全球客户超1250次的GMP质量审计和来自欧盟质量受权人（Qualified Person）的超145次审计。目前，药明生物的全球生产网络已有十五个获药品监管机构认证的生物药原液和制剂生产厂。

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WuXi Biologics' Four Manufacturing Facilities and Biosafety Testing Center Certified Again by European Medicines Agency for Ten Biologics

WUXI/SUZHOU,

Aug. 1, 2024

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that four manufacturing facilities and Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA), demonstrating the company's commitment to meeting rigorous international industry quality standards across its global network. 

Following comprehensive inspections of the company's facilities–specifically MFG1, MFG2, MFG5, and DP1 in Wuxi–EMA GMP certificates were issued for commercial and New Drug Application (NDA)-ready manufacturing and services for eight biologics, an endorsement to the company's capabilities in providing such services for global clients.  All of these facilities were previously approved by the EMA and other major regulatory authorities for the development of multiple biologic therapeutics. Furthermore, the company's Suzhou Biosafety Testing Center was once again certified by the EMA to provide services for ten novel therapies, including the eight biologics being manufactured in Wuxi. 

WuXi Biologics has a proven track record of strict quality compliance. Since 2017, the company has completed and passed 35 global regulatory agency inspections, more than 1,250 GMP quality audits by global clients, and more than 145 audits by EU Qualified Persons. Currently, WuXi Biologics has 15 GMP-certified drug substance and drug product facilities in its global network.

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