WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that five manufacturing facilities successfully passed the Pre-License Inspection (PLI) by the U.S. Food and Drug Administration (FDA), with no critical issues or data integrity findings.

药明生物（2269.HK）是全球领先的合同研究、开发和生产组织（CRDMO），宣布其五个生产设施成功通过了美国食品药品监督管理局（FDA）的上市前检查（PLI），未发现关键问题或数据完整性问题。

This achievement further affirms WuXi Biologics’ strong track record of regulatory compliance—a 100% success rate passing PLIs..

这一成就进一步证实了药明生物良好的合规记录——PLI审查100%的成功率。

The FDA’s inspection covered WuXi Biologics’ quality management system and the entire production processes of multiple facilities, including two drug substance facilities (MFG1 and MFG5) and three drug product facilities (DP1, DP2 and DP5) in Wuxi, China.  Passing the initial regulatory inspection by the FDA for DP5, the company’s first commercial pre-filled syringes (PFS) manufacturing facility, will allow WuXi Biologics to provide high-quality PFS manufacturing solutions to clients..

美国食品药品监督管理局 (FDA) 的检查涵盖了药明生物的质量管理体系和多个设施的整个生产流程，包括中国无锡的两个原料药设施（MFG1 和 MFG5）以及三个制剂设施（DP1、DP2 和 DP5）。通过 FDA 对 DP5（公司首个商业预充式注射器 (PFS) 生产设施）的初步监管检查后，药明生物将能够为客户提供高质量的 PFS 生产解决方案。

As of late 2024, WuXi Biologics has successfully passed 42 regulatory inspections, including 22 by the EU EMA and the FDA. Additionally, the company has received 97 license approvals from regulatory agencies around the world.

截至2024年底，药明生物已成功通过42次药品监管检查，其中包括欧盟EMA和FDA的22次检查。此外，公司还获得了来自全球监管机构的97项许可证批准。

Dr. Chris Chen, CEO of WuXi Biologics, commented: “At WuXi Biologics, our unwavering commitment to the highest global quality standards is embedded in everything we do. Maintaining a 100% success rate for regulatory inspections is a true reflection of our relentless pursuit of excellence in building a world-class quality system that not only meets but exceeds global regulatory requirements.

陈智胜博士，药明生物首席执行官评论道：“在药明生物，我们始终如一地坚持全球最高质量标准，并将其融入到我们的每一项工作中。保持100%的监管检查成功率，真正反映了我们不懈追求卓越，致力于打造一个不仅满足而且超越全球监管要求的世界级质量体系。”

WuXi Biologics will continue—with speed and efficiency—to enable global partners in delivering life-saving treatments, with the ultimate goal of benefiting patients worldwide.”.

药明生物将继续以高效和迅捷的方式，助力全球合作伙伴带来挽救生命的治疗，最终造福全世界的患者。”

About WuXi Biologics

关于药明生物

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide..

无锡生物制品有限公司（股票代码：2269.HK）是全球领先的合同研究、开发和生产组织（CRDMO），提供端到端的解决方案，使合作伙伴能够从概念到商业化发现、开发和生产生物制品，造福全球患者。

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects)..

药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12,000名技术娴熟的员工，利用其技术和专业知识，为客户提供高效且具成本效益的生物制品发现、开发和生产解决方案。截至2024年12月31日，药明生物正在支持817个综合客户项目，其中包括21个商业化生产项目（不包括新冠CMO项目）。

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG).

药明生物将可持续发展视为企业长期发展的基石，持续推动绿色技术创新，为全球合作伙伴提供先进的端到端绿色CRDMO解决方案，同时在环境、社会和治理（ESG）方面不断取得卓越成就。

Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain..

致力于创造共享价值，它与所有利益相关者合作，以促进积极的社会和环境影响，并推动负责任的实践，赋能整个价值链。

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

有关药明生物的更多信息，请访问：www.wuxibiologics.com

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Source: wuxibiologics.com

来源：wuxibiologics.com