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--国际化质量体系再获验证，持续赋能全球创新药研发与商业化生产
近日，上海皓元医药股份有限公司（股票代码：688131，以下简称“皓元医药”）全资子公司安徽皓元药业有限公司（以下简称“安徽皓元”）所属马鞍山科创园场地，正式收到美国食品药品监督管理局（FDA）出具的现场检查报告（Establishment Inspection Report，EIR）。
2026年8月，该场地首次接受美国FDA现场检查。本次检查覆盖原料药生产相关的六大质量管理体系，检查期间未收到FDA 483检查观察项通知书（Form FDA 483），标志着场地在国际化质量管理体系建设及cGMP规范化运营方面取得重要阶段性成果。
首次接受FDA现场检查
六大质量管理体系接受全面检验
根据FDA现场检查报告，本次检查依据FDA 2026财年工作计划开展，按照FDA合规检查程序《CPGM 7356.002F 原料药生产工艺检查》，采用系统性检查方法（Systems Approach），对场地原料药cGMP体系进行了全面检查。
检查范围涵盖质量体系、厂房设施与设备、物料管理、生产管理、包装与标签管理以及实验室控制六大体系，同时涉及该场地内生产的原料药和医药中间体。
本次检查重点核查场地原料药及医药中间体生产过程的质量管理、cGMP落地执行与合规运营情况。作为该场地首次接受的美国FDA现场检查，本次检查未收到FDA 483观察项通知书，体现了场地在质量体系建设、生产过程控制及规范化运营方面的持续投入与管理成效。
夯实国际化质量体系
提升全球规范市场服务能力
质量与合规是医药研发及生产服务的核心基础，CDMO企业深度参与全球医药产业链合作的重要保障。
皓元医药始终坚持以国际化质量标准为导向，持续推进质量管理体系建设，将cGMP管理要求贯穿工艺开发、技术转移、生产放大、质量控制及商业化生产等关键环节，不断提升项目交付的可靠性与可追溯性。
此次FDA现场检查的顺利完成，是马鞍山原料药及高活性原料药 (HPAPI) 生产场地持续完善国际化质量管理体系的重要体现，进一步展现了场地在原料药及高活性原料药生产、质量管理与合规运营方面的综合能力，也为皓元医药进一步拓展全球规范市场、承接国际客户项目奠定了更加坚实的基础。
强化API及HPAPI CDMO生产能力
赋能创新药商业化发展
作为皓元医药CDMO业务布局的重要组成部分，安徽皓元马鞍山科创园场地聚焦原料药CDMO及高活性原料药CDMO领域，持续提升工艺放大、cGMP生产及商业化供应能力，旨在为全球创新药企业提供高质量的研发与生产服务。
依托皓元医药在创新药研发服务、工艺开发及规模化生产方面的技术积累，场地能够与集团研发及生产平台形成协同，支持客户项目从研发阶段向临床及商业化生产阶段高效推进。
此次FDA现场检查顺利完成并取得积极结果，进一步验证了马鞍山场地在原料药CDMO及高活性原料药CDMO领域的合规运营与全球服务能力，为后续承接国际客户项目、支持创新药商业化生产奠定了坚实的质量基础。
高管寄语
以国际化质量标准护航客户项目
皓元医药
高级副总裁兼CTO 陈永刚 博士
场地首次接受FDA现场检查、无483观察项，是安徽皓元国际化质量体系建设的重要阶段性成果，也对我们后续的质量管理与项目交付提出了更高要求。
依托安徽皓元马鞍山科创园场地在API及HPAPI领域的技术积累与产能优势，我们已搭建起从技术转移、工艺放大、cGMP生产到商业化供应的全链条承接体系。未来我们将持续对标国际cGMP要求，不断提升质量管理水平与生产运营能力，为全球客户提供稳定、可靠、合规的CDMO服务。
持续深化全球化布局
以质量与技术创造长期价值
此次安徽马鞍山科创园场地首次接受FDA现场检查并取得积极结果，是皓元医药持续推进国际化质量体系建设的重要进展。
未来，皓元医药将继续坚持以客户需求为导向，以技术创新为驱动，以质量合规为基石，持续强化全球化研发与生产服务能力，深化从创新药研发到商业化生产的全生命周期服务布局，为全球医药创新企业提供高质量、高效率、可信赖的一体化CRO与CDMO服务，助力更多创新药项目加速走向临床与商业化。
皓元医药——以创新技术与国际化质量体系，赋能全球医药创新。
ChemExpress Completes First U.S. FDA Inspection at the Ma'anshan Site with No Form FDA 483 Observations
A Significant Milestone in Global Quality Compliance, Strengthening API and HPAPI CDMO Services for Global Pharmaceutical Innovation
ChemExpress (Shanghai Haoyuan Chemexpress Co., Ltd.) recently announced that its wholly owned subsidiary, Anhui Haoyuan Pharmaceutical Co., Ltd. (Anhui Haoyuan), has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) following the first FDA inspection of its Taodian Avenue Division (commonly referred to as ChemExpress' Ma'anshan site).
Conducted in August 2026, the inspection covered six key cGMP systems associated with active pharmaceutical ingredient (API) manufacturing. No Form FDA 483 inspectional observations were issued, marking an important milestone in the site's ongoing commitment to international quality standards, cGMP compliance, and operational excellence.
First FDA Inspection: Comprehensive Assessment of Six cGMP Systems
According to the FDA inspection report, the inspection was conducted under the FDA's Fiscal Year 2026 work plan and Compliance Program CPGM 7356.002F, Active Pharmaceutical Ingredient (API) Process Inspection, using a systems-based approach.
Using a systems-based approach, FDA investigators evaluated six key cGMP systems:
Quality System
Facilities and Equipment System
Materials System
Production System
Packaging and Labeling System
Laboratory Control System
The inspection also assessed the site's manufacturing operations for APIs and pharmaceutical intermediates intended for use in human drug products supplied to the U.S. market.
As the site's first U.S. FDA inspection, the outcome of no Form FDA 483 observations represents a significant achievement, reflecting ChemExpress' Ma'anshan Site's continued investment in quality management, manufacturing controls, and cGMP-compliant operations.
Strengthening Global Quality Standards to Serve Regulated Markets
Quality and regulatory compliance are fundamental to pharmaceutical development and manufacturing, particularly for CDMO partners supporting innovative therapies across global markets.
ChemExpress remains committed to continuously strengthening its quality management systems in alignment with international cGMP requirements. Quality and compliance are integrated throughout critical stages of pharmaceutical development and manufacturing, including process development, technology transfer, scale-up, quality control, cGMP manufacturing, and commercial production.
The successful completion of this FDA inspection reflects the continued advancement of quality management practices at the Ma'anshan site and demonstrates its capabilities in API and highly potent API (HPAPI) manufacturing, quality assurance, and regulatory compliance.
This milestone further strengthens ChemExpress' foundation for supporting international customers and expanding its CDMO services across global regulated markets.
Advancing API and HPAPI CDMO Capabilities from Development to Commercial Manufacturing
As an important component of ChemExpress' integrated CDMO network, the Ma'anshan site focuses on API and HPAPI CDMO services, with capabilities spanning process scale-up, cGMP manufacturing, and commercial supply.
Leveraging ChemExpress' expertise in pharmaceutical R&D, process chemistry, and manufacturing scale-up, the site works closely with the company's broader R&D and manufacturing network to support customers throughout the drug development lifecycle.
From early-stage development and technology transfer to clinical and commercial manufacturing, ChemExpress is committed to providing integrated, reliable, and scalable CDMO solutions that help pharmaceutical and biotechnology companies advance innovative therapies efficiently.
The positive outcome of this FDA inspection further reinforces the quality foundation supporting future API, HPAPI, and related CDMO projects for customers targeting global regulated markets.
Leadership Perspective: Quality and Compliance at the Core of Customer Success
Dr. Yonggang Chen, SVP and CTO of ChemExpress
Successfully completing our first U.S. FDA inspection with no Form FDA 483 observations is an important milestone in ChemExpress' Ma'anshan Site's ongoing development of an internationally aligned quality management system. It also reinforces our responsibility to maintain the highest standards of quality, compliance, and reliable project delivery.
Building on our technical expertise and manufacturing capabilities in APIs and HPAPIs, we have established an integrated service platform covering technology transfer, process scale-up, cGMP manufacturing, and commercial supply.
Looking ahead, we will continue to strengthen our quality systems and operational capabilities in accordance with international cGMP standards, providing global customers with reliable, compliant, and high-quality CDMO services.
Expanding Global CDMO Capabilities Through Quality, Innovation, and Operational Excellence
The successful completion of the first U.S. FDA inspection at the Ma'anshan site represents another important step in ChemExpress' ongoing efforts to strengthen its global quality and compliance capabilities.
Looking ahead, ChemExpress will continue to place customer needs at the center of its operations, with technological innovation and quality compliance serving as the foundations of its growth.
By further integrating its R&D expertise, cGMP manufacturing capabilities, and global service network, ChemExpress aims to deliver high-quality, efficient, and reliable end-to-end CRO and CDMO solutions, supporting pharmaceutical and biotechnology partners from drug discovery and development through clinical manufacturing and commercialization.
ChemExpress — Empowering Global Pharmaceutical Innovation Through Advanced Technologies and International Quality Standards.
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上海皓元医药股份有限公司（股票代码：688131）成立于2006年，专注于为全球制药和生物医药行业提供小分子、大分子及新分子类型药物发现领域的生命科学试剂的研发，原料药、中间体、起始物料及制剂的药物研发，工艺优化及商业化生产。公司始终将创新作为核心驱动力，以“产品+服务”模式，聚焦差异化发展，致力于打造覆盖药物研发及生产“起始物料 - 中间体 - 原料药 - 制剂”的一体化服务平台，加速赋能全球合作伙伴实现从临床前到商业化生产的全过程，让药物研发更高效，更快上市，更早惠及人类健康。
在生命科学试剂业务领域，公司已成为全球领先的科研化学品和生物试剂供应商，在中间体、特色原料药和制剂业务领域，公司致力于打造客户信赖的全球CRO&CDMO合作伙伴，在ADC早期发现到CDMO比较细分专业领域中，公司处于第一梯队。目前，公司已与多个地区的知名医药企业、科研院所、CRO公司建立了深度合作关系，被评为国家级专精特新“小巨人”企业、国家知识产权优势企业、上海市创新型企业总部、上海市企业技术中心等，荣登“上海硬核科技企业TOP100榜单”，荣获“科创板硬科技领军企业”、“中国医药CDMO企业20强”、中国科促会“科技创新奖一等奖”、“CPHI China医药国际化领军企业奖”、2025硬科硬客“出海先锋奖”等多项荣誉称号。
未来，公司将持续围绕“产业化、全球化、品牌化”发展战略，坚持“一切为了客户，一切源于创新”的服务宗旨，深耕小分子类型药物研发服务与产业化应用市场，积极向大分子、新分子类型深度拓展，打造具有国际竞争力的、世界一流的医药研发和生产服务企业，推动研发创新以改善全球病患的生存状态和生活质量。
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