Shanghai, China – March 31, 2025

中国上海——2025年3月31日

— WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, today announced that its Active Pharmaceutical Ingredient (API) manufacturing sites at Changzhou and Taixing in Jiangsu province of China, successfully passed U.S.

——药明康德，一家为医药和生命科学行业提供广泛研发和制造服务的全球性公司，今日宣布其位于中国江苏省常州和泰兴的活性药物成分（API）生产场地成功通过了美国的检查。

Food and Drug Administration (FDA) inspections back-to-back in March — both without a single observation and with no Form 483 issued. These achievements further demonstrate WuXi AppTec’s unwavering commitment to upholding the highest quality standards and to supporting global healthcare innovators in reliably delivering needed therapies to patients worldwide..

美国食品药品监督管理局 (FDA) 三月份连续检查均未出现任何观察项，也未发出483表格。这些成就进一步证明了药明康德始终坚守最高的质量标准，并致力于支持全球医疗创新者可靠地将所需疗法带给世界各地的患者。

The Company’s API site at Changzhou underwent a GMP surveillance inspection by the FDA that began on March 4. Covering 21 FDA-approved products, the inspection followed the FDA’s six-system inspection model. The FDA inspectors concluded the review one day ahead of schedule. No observation was raised..

公司的常州API工厂于3月4日开始接受FDA的GMP监督审查。此次审查涵盖了21种FDA批准的产品，并遵循了FDA的六系统检查模型。FDA检查员提前一天完成了审核，没有提出任何观察项。

On March 21, 2025, the API site at Taixing also completed a Pre-Approval Inspection (PAI) for the commercial manufacturing of a peptide-based therapeutic, with no observation. The site presented its state-of-the-art infrastructure, the team’s strong technical expertise, and the high level of compliance demonstrated through its systems, documentation, and records.

2025年3月21日，泰兴的API站点也完成了基于肽类治疗药物商业化生产的预批准检查（PAI），无任何观察项。该站点展示了其最先进的基础设施、团队强大的技术专长以及通过其体系、文件和记录体现出的高度合规性。

Operational since September 2023, the 169-acre Taixing site is the company’s newest and largest API manufacturing facility. The successful inspection confirms the site’s readiness to support commercial API supply to the global market..

自2023年9月投入运营以来，占地169英亩的泰兴基地是该公司最新且规模最大的原料药生产设施。此次成功检查确认了该基地已准备好支持向全球市场供应商业化原料药。

“Our team’s consistent focus on quality and compliance is key to enabling our global partners,” said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. “We’re pleased that both the Changzhou and Taixing sites passed their FDA inspections with no observation. These successful results further reinforce WuXi AppTec’s dedication to providing high-quality R&D and manufacturing solutions that support our customers worldwide in accelerating new drug development and commercialization for the benefit of patients.”.

“我们团队始终如一地关注质量和合规性，这是赋能全球合作伙伴的关键，”药明康德联席首席执行官陈民章博士表示，“我们很高兴常州和泰兴两地的设施都顺利通过了FDA检查，并且没有任何发现项。这些成功的成果进一步证明了药明康德致力于提供高质量的研发和生产解决方案，支持全球客户加速新药开发和商业化，造福患者。”

The Changzhou and Taixing sites are critical manufacturing bases of WuXi STA, the company’s small molecule CDMO platform, and WuXi TIDES, which provides integrated CRDMO services for oligonucleotides, peptides, and synthetic conjugates. Both sites support the manufacturing of APIs and intermediates across a wide range of chemical modalities..

常州和泰兴基地是公司小分子CDMO平台合全药业（WuXi STA）以及为寡核苷酸、多肽和合成结合物提供一体化CRDMO服务的合全TIDES的关键生产基地。这两个基地支持各种化学类型API及中间体的生产。

WuXi AppTec continues to invest in capacity expansion to meet growing global demand. The company’s investment in its Couvet, Switzerland, site resulted in doubling oral dose capacity over the course of 2024. Meanwhile, WuXi AppTec continued to build its U.S. (Middletown, DE) site, which is expected to commence operations by the end of 2026.

药明康德继续投资扩大产能，以满足不断增长的全球需求。该公司对瑞士库韦特基地的投资使得2024年口服剂量生产能力翻倍。同时，药明康德继续建设其美国（特拉华州米德尔敦）基地，预计将在2026年底前投入运营。

In May 2024, the company announced the groundbreaking of Singapore R&D and manufacturing site; Phase I expects to commence operations in 2027. .

2024年5月，该公司宣布新加坡研发和制造基地破土动工；一期预计将于2027年开始运营。

About WuXi AppTec

关于药明康德

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions.

作为一家在亚洲、欧洲和北美开展业务的全球性公司，药明康德提供广泛的研发和生产服务，助力全球制药和生命科学行业推进发现并为患者提供突破性治疗。通过其独特的商业模式，药明康德一体化的端到端服务包括化学药物CRDMO（合同研究、开发和生产组织）、生物发现、临床前测试和临床研究服务，帮助客户通过经济高效和高效率的解决方案提高医疗产品开发的生产力。

WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024 and its open-access platform is enabling around 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that 'every drug can be made and every disease can be treated.' Please visit: .

药明康德在2024年连续第四年获得MSCI的AA级ESG评级，其开放平台正在帮助来自30多个国家的约6000名客户改善有需要人群的健康状况，并实现“让每一个药物都能被生产，每一个疾病都能被治疗”的愿景。请访问：。

http://www.wuxiapptec.com

http://www.wuxiapptec.com