WuXi Biologics Passes Another FDA GMP Inspection, Reinforcing Its Quality Track Record and Commercial Supply Reliability
WuXi Biologics' drug substance and drug product facilities at the Wuxi Mashan site passed an unannounced two-week FDA GMP inspection, covering multiple FDA-approved monoclonal, bispecific, fusion-protein and enzyme products. The result reinforces the site's 13-year 100% audit-pass record and strengthens reliable commercial supply to U.S. partners.
Wuxi, China, September 24, 2026 — WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its drug substance (DS) and drug product (DP) manufacturing facilities at the Wuxi Mashan site successfully passed a two-week GMP inspection conducted by the U.S. Food and Drug Administration (FDA). The successful inspection further strengthens the Company's capabilities to ensure the reliable supply of its partners' commercial products to the U.S. market.
The unannounced FDA GMP inspection covered multiple FDA-approved products, including monoclonal antibodies, bispecific antibodies, fusion proteins, and enzyme products. The successful completion of this routine FDA GMP inspection once again demonstrates WuXi Biologics' strict adherence to FDA GMP requirements, further reinforcing the Company's outstanding regulatory compliance track record and underscoring its robust and reliable quality system, proven GMP operational excellence, and integrated capabilities to support global commercial manufacturing and supply.
WuXi Biologics' Wuxi Mashan site was the first biopharmaceutical manufacturing facility in China approved by both the FDA and the European Medicines Agency (EMA) for commercial production. By integrating DS and DP manufacturing capabilities within a single site and leveraging its end-to-end service platform, WuXi Biologics streamlines technology transfer, process scale-up, and commercial supply, accelerating project execution and enhancing supply chain efficiency. Over the past 13 years, the site has achieved a 100% success rate across more than 600 regulatory and client audits and has supported the global launch of over 20 biologics.
The successful completion of this FDA GMP inspection reaffirms our commitment to the highest standards of quality and operational excellence. Quality remains one of our key competitive strengths and a cornerstone of the trust our global partners place in us. As global demand for commercial supply continues to grow and regulatory expectations continue to rise, we remain dedicated to providing our partners with reliable, high-quality manufacturing services through our robust quality system, global manufacturing network, and expanding commercial capabilities. Through these efforts, we help our global partners bring innovative therapies to patients worldwide faster, more reliably, and at greater scale.
WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry's rigorous quality standards. As of the end of June 2026, it has successfully passed 49 regulatory inspections, including 22 conducted by the FDA and EMA, and secured 166 facility license approvals. In addition, WuXi Biologics has passed more than 2,000 GMP quality audits by global clients, including over 280 audits by EU Qualified Persons. Currently, the company operates 26 drug substance facilities and 19 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 14,000 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 June 30, 2026, WuXi Biologics is supporting 1064 integrated client projects, including 78 in Phase III and 28 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 green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). 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.