药明生物第18个制剂生产厂GMP放行并投产，加速拓展从原液到制剂的一体化产能

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中国上海，

2026年5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，其位于上海奉贤基地的生物制剂十五厂（DP15）已于今年4月获得GMP放行，并于近期顺利完成多个工程批次和GMP批次生产，成功交付临床样品以满足客户申报和临床供应需求。这是药明生物在全球范围内投产的第18个生物制剂生产厂。

DP15厂房布局与产线配置全面对标国际监管要求，同时满足临床阶段项目对灵活性与效率的综合考量。在此基础上，DP15配置高端隔离器灌装产线，具备液体及冻干制剂的生产能力，配置100%装量检测、灌装充氮保护、冻干低温进料等多种功能，提供覆盖2R至20R多规格的灌装解决方案。该生产厂将与上海奉贤基地其他生产设施高效协同，加速生物药从研发到GMP生产转化的全流程推进，大幅加快客户项目的交付速度。

陈智胜

博士

药明生物首席执行官

DP15顺利完成GMP放行，进一步增强了公司在从原液到制剂的一体化交付能力。依托药明生物的全球CRDMO网络布局，我们将助力客户缩短技术转移周期、提升项目执行效率，稳步推进其关键研发里程碑，赋能更多创新生物药加速惠及患者。

上述能力得益于药明生物长期构建的全球一体化服务体系。药明生物已在中国、美国、爱尔兰、德国、新加坡布局5个研发中心、10个开发中心和18个生产中心，共计24个原液生产厂和18个制剂生产厂投入运营，为全球客户提供端到端的一体化生产解决方案及服务。截至2025年底，公司累计交付2350余批原液及2260余批制剂，完成46次全球监管机构检查，均以零关键发现项和零数据完整性问题100%通过，其中包括22次欧洲药品管理局（EMA）及美国食品药品监督管理局（FDA）检查，并在FDA药品上市批准前检查（PLI）中保持100%通过率。此外，公司还顺利通过全球客户超过1800次GMP质量审计，包括230余次欧盟质量受权人（QP）审计，彰显了其全球网络一以贯之的高质量交付能力。

围绕生物药从临床开发到商业化放量的不同阶段需求，药明生物已构建起覆盖全面、结构成熟的制剂能力体系。依托完善的全球网络布局和高浓度制剂开发平台WuXiHigh™、透明质酸酶共制剂一体化服务以及大体积可穿戴式装置解决方案，公司可提供涵盖液体及冻干西林瓶制剂、预灌封注射器（PFS）、双腔卡式瓶注射器（DCC）以及多类安全型与自动化组合产品在内的主流给药形式，并在无锡、苏州、上海、杭州、成都、新加坡及美国新泽西州等多个基地实现业务协同与卓越运营。

关于药明生物

药明生物（股票代码：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，造福全球病患。

依托连结中国、美国、爱尔兰、德国和新加坡的全球网络，药明生物汇聚逾13000名员工，包括在生物药研发及生产、技术创新和卓越运营等领域的行业专家与科学家。公司凭借领先的技术平台和精深的专业能力，为客户提供高效、成本优势、规模化的生物药解决方案，精准满足不同阶段的客户需求。此外，公司还将数字化能力与基础设施系统性嵌入生物药研发、实验室运营与生产制造的全价值链，把数据、计算与预测能力转化为更透明的客户合作体验、更快的研发进程、更智能的运营管理与更高效的生产交付。截至2025年12月底，药明生物帮助客户研发和生产的综合项目高达945个，其中包括74个临床III期项目，25个商业化生产项目，复杂分子项目合计占比超过公司总项目数50%。

药明生物以可持续发展为长期业务增长的基石。公司持续推动绿色创新技术，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ESG方面不断取得卓越成就。秉承创造共享价值的理念，公司携手利益相关方构建可持续发展生态，通过负责任运营模式推动社会价值与生态效益双提升，实现全价值链的协同赋能。

更多信息，请访问：www.wuxibiologics.com。

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WuXi Biologics Achieves GMP Release of 18th Drug Product Facility, Advancing Integrated Drug Substance to Drug Product Capabilities

Shanghai, China 

May 27, 2026

WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its Drug Product Facility 15 (DP15), located at the company's Fengxian site in Shanghai, achieved GMP release in April. The facility has since progressed seamlessly into operation, completing multiple engineering and GMP batches, delivering clinical supplies to support the client's regulatory filings and clinical development needs. The DP15 facility is the 18th operational drug product facility in WuXi Biologics’ global network.

Designed and built to meet international regulatory standards, DP15 delivers the flexibility and operational efficiency required for clinical-stage programs. The facility is equipped with advanced isolator-based aseptic filling lines, enabling both liquid and lyophilized drug product (DP) manufacturing, and features multiple advanced capabilities — including 100% fill weight check, nitrogen overlay, and low-temperature loading for lyophilization. Fill-finish solutions are provided for a variety of vial sizes, ranging from 2R to 20R. Fully integrated with surrounding site operations, DP15 is positioned to further accelerate the transition from development to GMP manufacturing, and drive faster, more efficient delivery for client programs.

Dr. Chris Chen

CEO

WuXi Biologics

The successful GMP release of DP15 further strengthens our integrated delivery capabilities from drug substance to drug product. Leveraging our global CRDMO network, we will continue to enable clients to shorten technology transfer timelines, enhance execution efficiency, and advance key development milestones, ultimately accelerating the delivery of innovative biologics to patients worldwide.

These capabilities are built upon WuXi Biologics' well-established, globally integrated service platform. The company operates across China, the United States, Ireland, Germany, and Singapore, with 5 research centers, 10 development centers, and 18 manufacturing sites, including 24 drug substance facilities and 18 drug product facilities currently in operation, providing end-to-end integrated solutions and services for global partners. By the end of 2025, WuXi Biologics has delivered over 2,350 drug substance batches and over 2,260 drug product batches, and passed 46 regulatory inspections worldwide, including 22 inspections by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), with a 100% success rate, no critical findings, and no data integrity issues. In addition, the company has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons, demonstrating consistent high-quality delivery across its global network.

WuXi Biologics has established a comprehensive and robust drug product capability to address the evolving needs of biologics across clinical development and commercial-scale manufacturing. Leveraging its global network and advanced technologies, including the WuXiHigh™, hyaluronidase co-formulation, and large-volume device solutions, the company offers a full range of delivery formats, including liquid and lyophilized vial formulations, pre-filled syringes (PFS), dual-chamber cartridges (DCC), and a variety of safety and automated combination products. These capabilities are supported by coordinated operations across multiple global sites, spanning Wuxi, Suzhou, Shanghai, Hangzhou, Chengdu, Singapore, and Cranbury (New Jersey, USA).

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 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. 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.

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

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