首个海外GMP认证！药明生物德国生物制剂厂商业化生产获德国卫生监管机构认证|药明生物_新浪财经

原标题：首个海外GMP认证！药明生物德国生物制剂厂商业化生产获德国卫生监管机构认证来源：药明生物

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首个海外GMP认证，彰显了药明生物世界一流的质量标准体系

“药明生物速度”应用于全球的最佳案例之一，从厂房验证到获得生产认证仅历时12个月

德国，勒沃库森

2021年7月26日

全球领先的开放式生物制药技术平台公司药明生物（wuxi biologics, 2269.hk）今日宣布位于德国勒沃库森的生物制剂厂（DP7）已获得德国卫生监管机构认证。这标志着药明生物首次在中国以外的地区成功践行“药明生物速度”和“药明生物质量”，为公司未来深化全球布局奠定了坚实基础。

此前，5名德国科隆及其他地区卫生监管机构审查员对DP7进行了为期6天的详细检查，旨在评估DP7的GMP生产资质，及其生产的一款产品的上市申请。检查范围包括质量体系、文件和培训体系、厂房设施及设备、无菌生物制剂生产、物料与供应商管理、质量控制实验室，以及电子系统和数据完整性。预计下周起，DP7将开始为一款预定产品提供商业化生产服务。

药明生物首席执行官陈智胜博士表示：“作为药明生物全球布局的重要基石之一，DP7此次获得德国卫生监管机构认证将助力公司更好地为客户提供卓越的商业化生产服务，巩固‘全球双厂生产’战略。该认证也是药明生物国际化战略中的关键里程碑，再次有力地证明了公司世界一流的质量标准体系。我们也将继续以最高质量标准赋能全球合作伙伴开发和生产生物药，造福广大病患。”

2020年1月，药明生物宣布收购拜耳位于德国勒沃库森的生物制剂工厂，并在同年4月正式接管该工厂的运营工作等。尽管新冠疫情带来了诸多困难，但药明生物勒沃库森团队在短短12个月内完成了一个又一个考验，打造了一支超过200名生产、质量和工程等专业人员组成的优秀团队，完成所有厂房验证和生产准备工作，并成功获得德国卫生监管机构颁发生产许可证。

陈博士进一步补充道，“在全球疫情形势依然严峻的情况下，药明生物勒沃库森团队克服重重挑战，交出了一份出色的成绩单。我们为所有辛勤奉献的员工感到自豪，他们是‘药明生物速度’和‘药明生物质量’的最佳海外代言人！”

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关于药明生物

药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。

截至2021年3月22日，在药明生物平台上研发的综合项目达361个，包括190个处于临床前研究阶段，137个在临床早期（I期，II期）阶段，32个在后期临床（III期）以及2个在商业化生产阶段。预计到2024年后，公司在中国、爱尔兰、美国、德国和新加坡规划的生物制药生产基地合计产能将达到43万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。

药明生物将环境、社会和治理（ESG）视为业务发展和企业精神的重要组成部分，并致力于成为全球生物制药领域ESG领导者。公司应用更绿色环保的新一代生物制药技术和能源持续为全球合作伙伴赋能，并成立了由首席执行官领导的ESG委员会，在提升运营效率的同时践行可持续性发展承诺。

如需更多信息，请浏览：www.wuxibiologics.com。

WuXi Biologics Received Commercial Manufacturing License from German Health Authorities for its German Drug Product Facility first GMP manufacturing authorization outside of China, validating WuXi Biologics' world-class quality system Only 12 months from facility qualification to licensure demonstrating global adoption of "WuXi Biologics speed"

Leverkusen, Germany July 26, 2021

WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has received the License of Manufacturing Permit from German health authorities for its drug product facility (DP7) in Leverkusen, Germany. The permit successfully demonstrates for the first time that premier Quality together with Record Speed WuXi Biologics consistently delivered in China can also be applied in global countries.

The six-day inspection was conducted by five inspectors from the Health Authority of Cologne District Government (Bezirksregierung K ln) and other regional inspectorates. The scope of the inspections comprised not only the areas of cGMP manufacturing required for receiving the permit, but also commercial production approval. The inspection covered quality systems, documents and training, facilities, utilities and equipment qualifications, aseptic DP production, material and supplier management, QC Labs, as well as electronic systems and data integrity. The facility is slated to begin commercial manufacturing of a key product next week.

Dr. Chris Chen, CEO of WuXi Biologics, said, "We're pleased that DP7 facility in Leverkusen, one of the cornerstones of our Global Dual Sourcing strategy, successfully passed the GMP inspection for biologics commercial manufacturing from an EU regulatory agency. This license represents another remarkable milestone in our efforts to establish premier-quality operations on a global scale. We will continue to strictly adhere to the quality standards set forth by the health authorities and to produce urgently needed biologics for the benefit of patients worldwide."

In January 2020, WuXi Biologics announced the acquisition of the drug product manufacturing facility in Leverkusen, Germany from Bayer. WuXi Biologics took over the plant operations in April 2020. Despite the challenges brought on by the COVID-19 pandemic, it only took 12 months to assemble the comprehensive manufacturing, quality and engineering team of over 200 employees, conduct all facility qualifications and startup activities to obtain the License of Manufacturing Permit.

"We are extremely proud of the effort by our dedicated staff in Leverkusen to obtain the permit despite all the restrictions put in place during the global pandemic, and it shows their unwavering commitment to accomplish this task at WuXi Bio Speed while maintaining WuXi Bio Quality," added Dr. Chen.

About WuXi Biologics

- Scroll down for more company introduction -

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients.

The company is currently conducting (as of March 22, 2021) a total of 361 integrated projects: 190 in pre-clinical development; 137 in early-phase (phase I and II) clinical development; 32 in late-phase (phase III) development; and 2 in commercial manufacturing. With a total estimated capacity at around 430,000 liters for biopharmaceutical production planned by 2024 in China, Ireland, the U.S., Germany, and Singapore, WuXi Biologics will provide its biomanufacturing partners with an even more robust and premier-quality global supply chain network.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of its ethos and business strategy and aims to become a global ESG leader in biologics manufacturing. We use next-generation cleaner biomanufacturing technologies and cleaner energy to enable global clients. We have also established an ESG committee led by the CEO to increaseefficiency while advancing commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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注：本信息不构成药明生物的信息披露或投资建议