SHIJIAZHUANG, China, July 9, 2026 /PRNewswire/ — WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG8 drug substance manufacturing facility located in Hebei has successfully passed the Pre-License Inspection (PLI) by the U.S. Food and Drug Administration (FDA), supporting commercial manufacturing for a potential blockbuster autoimmune therapy.
The seven-day FDA inspection conducted by three inspectors covered MFG8’s quality management system and drug substance manufacturing processes. Passing this inspection further reinforces WuXi Biologics’ outstanding regulatory compliance track record and demonstrates the company’s robust and reliable quality system, proven GMP execution excellence, and integrated capabilities to support reliable global commercial manufacturing.
MFG8 is an important part of WuXi Biologics’ global manufacturing network. Equipped with twelve 4,000L single-use bioreactors, the facility leverages WuXi Biologics’ distinctive “scale-out” strategy to offer flexible commercial manufacturing at scales ranging from 4,000L to 20,000L. In addition, MFG8 incorporates the latest practices in sustainable construction and applies state-of-the-art technologies, including digital platforms and the rooftop photovoltaic system, to advance carbon reduction, resource reuse, and recycling.
Dr. Chris Chen, CEO of WuXi Biologics, commented: “MFG8’s successful FDA Pre-License Inspection pass is a strong testament to WuXi Biologics’ commitment to global quality and compliance standards. This PLI pass reflects our sustained investment in a world-class quality system and our proven capability to support partners in advancing global commercial manufacturing. We are pleased to help bring this potential blockbuster autoimmune therapy to patients through our high-quality manufacturing capabilities. Moving forward, WuXi Biologics will continue to empower global partners with a reliable quality system and accelerate the delivery of innovative biologics to more 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 25 drug substance facilities and 18 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 April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 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.
*The winner of the “2026 Biologics CDMO of the Year” (Large CDMOs) (Life Science Connect / Outsourced Pharma)
*The winner of the “2026 Best Contract Development & Manufacturing Organization Award” (ABEA)
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