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药明生物成都微生物商业化生产基地实现主体结构完工及关键设备到场

药明生物成都微生物商业化生产基地实现主体结构完工及关键设备到场 药明生物
2026-04-24
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导读:稳步推进该基地于2026年底实现GMP投产


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成都,

2026年4月24日


全球领先的合同研究、开发与生产(CRDMO)服务公司药明生物(2269.HK)今日宣布,其位于成都的微生物商业化生产基地已顺利实现主体结构完工和关键设备到场。这一重要里程碑标志着公司正稳步推进该基地于2026年底实现GMP投产。



该微生物生产基地于去年6月在成都市温江区正式启动建设,规划面积约95000平方米,专注于生物药原液(DS)和制剂(DP)生产。



抗体偶联药物、细胞治疗、双/多抗、癌症疫苗等新一代疗法,会利用多肽、酶、抗体片段、纳米抗体及细胞因子等重组蛋白,而这些重组蛋白可依托微生物发酵技术,并结合相应的下游纯化与制剂工艺,实现规模化生产。随着新兴生物药分子类型的持续发展,微生物发酵技术正被越来越广泛地应用,其在产量、开发速度、规模化能力、工艺一致性及成本效率等方面的优势日益凸显。


药明生物微生物商业化生产基地将配备15000升发酵罐,原液年产能可达110批次,未来最大发酵规模可拓展至60000升。同时,该基地还将落地与维昇药业共建的中国首条双腔冻干制剂生产线,并配备西林瓶生产线,制剂年产能超过1000万支,进一步拓展其在复杂制剂商业化生产方面的能力。


值得一提的是,该基地在上下游生产环节全面引入自动化与数字化系统,支持稳定、可靠的GMP生产,提升合规性、运营效率与数据完整性。在基地设计过程中,ESG理念亦被系统性融入,通过海绵城市设计、光伏(PV)组件应用等绿色建筑实践,提升整体资源与能源利用效率。



陈智胜

博士

药明生物首席执行官



成都基地实现主体结构完工,是我们推进微生物商业化生产能力建设进程的关键一步。该基地可满足高效技术转移与稳定商业化供应,支持微生物发酵技术在新兴分子类型及先进治疗领域中日益增长的应用需求。结合我们在上海和杭州的研发和临床生产能力,药明生物能够为全球创新药企提供从菌株开发到商业化生产的端到端CRDMO服务。





依托公司自主开发的大肠杆菌表达系统EffiX™,药明生物可实现重组蛋白产量高达15g/L,6个月完成从质粒DNA到IND申报的完整CMC交付。药明生物微生物技术平台构建多层次、灵活的产能体系,可支持从15升、3000升至15000升的放大生产,精准匹配药物从临床前、临床阶段到商业化阶段的不同需求。截至2025年底,药明生物一体化微生物发酵平台已成功支持128个分子的开发与生产。


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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 Chengdu Microbial Commercial Manufacturing Site Achieves Structural Completion and Key Equipment Arrival


Chengdu, 

April 24, 2026



WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced the structural completion and key equipment arrival at its microbial commercial manufacturing site in Chengdu, marking an important milestone as the company advances toward GMP release for production by the end of 2026.


The microbial manufacturing site, broke ground last June in Wenjiang District of Chengdu, spans approximately 95,000 square meters and is designed for commercial drug substance (DS) and drug product (DP) manufacturing of microbial-derived biologics. A broad spectrum of next-generation therapies, including ADCs, cell therapies, bi-/multi-specific antibodies, and cancer vaccines, leverage recombinant proteins such as polypeptides, enzymes, antibody fragments, nanobodies, and cytokines. These recombinant proteins can be manufactured at scale through microbial fermentation, supported by compatible downstream purification and formulation processes. Microbial fermentation is gaining broad adoption across emerging biologic modalities, driven by its advantages in yield, development speed, scalability, process consistency, and cost efficiency.


Upon completion, the manufacturing site will be equipped with a 15,000 L fermenter, enabling up to 110 DS batches annually, with long-term expansion potential up to 60,000 L. It will also feature China's first dual-chamber lyophilization production line, jointly established with VISEN Pharmaceuticals, along with a vial-filling line that offers commercial DP manufacturing capacity of more than 10 million vials per year, further enhancing its commercial manufacturing capabilities for complex formulations.


In addition, the manufacturing site incorporates integrated automation and digital systems across upstream and downstream operations to support reliable GMP manufacturing, strengthening compliance, operational efficiency, and data integrity. ESG concepts are also embedded into the site's design through green building practices such as sponge city design and the adoption of photovoltaic (PV) modules, enhancing overall resource and energy efficiency.



Dr. Chris Chen



CEO

WuXi Biologics



Receiving GMP certification from the MFDS demonstrates our continued commitment to the global standards of quality and regulatory compliance. It further strengthens our support for customers across South Korea and the Asia‑Pacific region, while reaffirming our proven domain expertise and systematic strengths in the development and commercial manufacturing of complex biologics, including bispecific antibodies. We will continue to build on our world‑class quality system and end‑to‑end manufacturing capabilities to enable partners to accelerate the delivery of innovative biologics to patients worldwide.





WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry's rigorous quality standards. As of the end of 2025, it has successfully passed 46 regulatory inspections, including 22 conducted by the FDA and EMA, and secured 136 facility license approvals. The company also holds an industry-leading record, achieving a 100% pass rate for FDA Pre-License Inspection (PLI). In addition, WuXi Biologics has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons. Currently, the company operates 15 GMP-certified drug substance and drug product facilities within its global network. Its world-class quality and compliance capabilities underpin long-standing trust from clients 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 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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info@wuxibiologics.com

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PR@wuxibiologics.com


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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