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无锡
2025年2月27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,公司无锡基地的生物药原液生产厂(MFG2和MFG5)再次通过日本药品医疗器械综合机构(PMDA)GMP检查。
公司以零缺陷通过此次涵盖设施质量体系及生产全流程的现场检查,彰显了其在满足全球监管要求方面的卓越能力。
截至目前,药明生物已累计成功通过42次全球药品监管机构检查,并获得美国、欧洲、中国、新加坡、日本及加拿大等国家和地区药监部门颁发的97项生产许可证。这些持续出色的监管检查成绩充分证明了公司稳定可靠的质量体系完全符合全球标准。

陈智胜
博士
药明生物首席执行官

世界一流的质量体系是我们可持续发展的基石,也为全球生产基地服务各国客户筑牢根基。药明生物将继续赋能全球合作伙伴加速开发和生产创新生物药,造福广大病患。





关于药明生物
药明生物(代码:2269.HK)是一家全球领先的合同研究、开发和生产(CRDMO)公司。公司通过开放式、一体化生物制药能力和技术赋能平台,提供全方位的端到端服务,帮助合作伙伴发现、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。
药明生物在中国、美国、爱尔兰、德国和新加坡拥有超过12000名员工。通过药明生物的专业服务团队,以及先进技术和精深洞见,公司为客户提供高效经济的生物药解决方案。截至2024年12月底,药明生物帮助客户研发和生产的综合项目高达817个,其中包括21个商业化生产项目(不包括新冠项目)。
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药CRDMO领域的ESG领导者,例如应用更绿色环保的新一代生物制药技术和能源等引领行业发展。公司成立了由首席执行官领导的ESG委员会,全面落实ESG战略并践行可持续性发展承诺。更多信息,请访问:www.wuxibiologics.com。


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WuXi Biologics Again Passed GMP Inspection by Japan PMDA
Wuxi
February 27, 2025
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has again passed the GMP inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its drug substance facilities (MFG2 and MFG5), in Wuxi city.
This onsite inspection covered the facilities' quality processes and the entire production system. It concluded without issues, demonstrating the company's robust expertise in meeting global regulatory requirements.
To date, WuXi Biologics has successfully passed 42 regulatory inspections and has received 97 license approvals from drug administration agencies across multiple countries and regions, including the U.S., Europe, China, Singapore, Japan and Canada. The company's track record of successful inspections underscores the reliability and full compliance of its quality system with global regulatory standards.
Dr. Chris Chen
Chief Executive Officer
WuXi Biologics

Our world-class quality system is the cornerstone to maintain the company's strong sustainable growth and has laid a solid foundation for our global network to support our clients worldwide. WuXi Biologics will continue to enable global partners in delivering life-saving treatments with speed and efficacy, ultimately benefiting patients worldwide.





About
WuXi Biologics
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.
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).
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to be an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our 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

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