药明康德常州及泰兴原料药基地成功通过美国FDA检查 | Bilingual News

▎药明康德

上海，2025年4月1日 - 药明康德今日宣布，公司位于江苏常州及泰兴的两个原料药基地于3月相继以零缺陷成功通过了美国食品药品监督管理局（Food and Drug Administration，FDA）检查，FDA未签发任何“483表格”（检查发现项报告）。这一结果再次彰显了药明康德始终恪守全球最高质量标准，坚定赋能合作伙伴加速新药研发，造福全球患者的不懈承诺。

3月4日，美国FDA对常州原料药基地展开了未预先通知的GMP符合性检查（又称“飞行检查”），涵盖六大GMP系统和21款已获FDA批准的产品。FDA检查官提前一天完成所有核查，未发现任何不符合项。

3月21日，泰兴原料药基地顺利通过美国FDA针对1款多肽创新药商业化生产进行的上市前检查（Pre-Approval Inspection）。检查过程中未发现任何不符合项。泰兴基地在设施配套、技术团队实力，系统运行、文件管理及记录方面展示了高度合规性。该基地于2023年9月正式投产，占地面积68.4万平方米，是药明康德最新、规模最大的原料药生产基地。此次顺利通过FDA检查，标志着泰兴基地已具备面向全球市场提供原料药商业化供应的能力。

药明康德联席首席执行官陈民章博士表示：“质量和合规是公司赋能全球客户的重要基石。我们很高兴常州和泰兴两个基地接连顺利通过了FDA检查，且没有任何不符合项。这为公司更好地赋能全球客户，持续提供高质量的研发和生产解决方案，奠定了坚实基础。我们将继续助力合作伙伴加速新药开发及商业化进程，为广大病患带来健康福音。”

常州和泰兴基地是合全药业（小分子CDMO平台）以及WuXi TIDES（为寡核苷酸、多肽及复杂化学偶联药物开发提供一体化服务的CRDMO平台）全球布局的重要组成部分，两个基地均可为各种复杂合成分子类型的开发提供原料药及中间体生产服务。

药明康德近年来在全球范围内持续投资扩展产能，以满足日益增长的市场需求，包括持续投资瑞士库威基地，2024年实现产能翻倍。同时，公司稳步推进美国米德尔顿基地建设，计划于2026年底投入运营。2024年5月，新加坡研发及生产基地正式开工建设，基地一期计划于2027年投入运营。

关于药明康德

药明康德（股票代码：603259.SH/2359.HK）为全球医药及生命科学行业提供一体化、端到端的新药研发和生产服务，在亚洲、欧洲、北美等地均设有运营基地。药明康德通过独特的"CRDMO"业务模式，不断降低研发门槛，助力客户提升研发效率，为患者带来更多突破性的治疗方案，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研究等领域。2024年，药明康德连续第四年被MSCI评为ESG（环境、社会及管治）AA级。目前，公司的赋能平台正承载着来自全球30多个国家约6,000家合作伙伴的研发创新项目，致力于将更多新药、好药带给全球病患，早日实现"让天下没有难做的药，难治的病"的愿景。更多信息，请访问公司网站：www.wuxiapptec.com

WuXi AppTec’s Changzhou and Taixing API Sites Successfully Pass FDA Inspections

Shanghai, China – April 1, 2025 — 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. 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.

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.

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. 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.

“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.”

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.

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

About WuXi AppTec

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. 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: http://www.wuxiapptec.com