(SeaPRwire) –   WUXI, China, April 23, 2026 — WuXi Biologics (2269.HK), a premier global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that three of its Wuxi-based manufacturing sites—Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2), and the Drug Product Packaging Center (DPPC)—have been granted Good Manufacturing Practice (GMP) certification by the South Korea Ministry of Food and Drug Safety (MFDS). This accreditation enables WuXi Biologics to provide comprehensive commercial manufacturing services, encompassing both drug substance and drug product, for a bispecific antibody therapy intended for biliary tract cancer patients.

During a five-day on-site audit, all three facilities cleared the MFDS evaluation without any major or critical observations. This success underscores the company’s rigorous quality and compliance frameworks, as well as its proven ability to conduct large-scale, GMP-compliant manufacturing for sophisticated biologic projects.

Within the company’s international GMP manufacturing network, MFG5, DP2, and DPPC work in tandem to offer integrated, end-to-end solutions, including drug substance production, fill-finish services, and specialized packaging, facilitating the efficient commercial distribution of advanced biologic treatments.

Dr. Chris Chen, CEO of WuXi Biologics, stated, “Securing MFDS GMP certification highlights our ongoing dedication to maintaining global quality and regulatory standards. This achievement bolsters our support for partners throughout South Korea and the broader Asia-Pacific region, while reinforcing our technical expertise and systematic capabilities in developing and manufacturing complex biologics, such as bispecific antibodies. We remain committed to leveraging our world-class quality systems and end-to-end manufacturing infrastructure to help our partners expedite the delivery of innovative therapies to patients globally.”

WuXi Biologics maintains a strong history of adhering to stringent industry quality benchmarks. By the close of 2025, the company had successfully navigated 46 regulatory inspections, including 22 from the FDA and EMA, and obtained 136 facility licenses. Notably, the company holds an industry-leading 100% pass rate for FDA Pre-License Inspections (PLI). Furthermore, WuXi Biologics has cleared over 1,800 GMP quality audits from international clients, including more than 230 audits conducted by EU Qualified Persons. Currently, the firm operates 15 GMP-certified drug substance and drug product facilities globally, with its commitment to quality and compliance serving as the foundation for its long-term client partnerships.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) providing end-to-end solutions that empower partners to discover, develop, and manufacture biologics—from initial concept to commercial production—for the benefit of patients worldwide.

With a workforce of over 13,000 employees across China, the United States, Germany, Ireland, and Singapore—comprising experts in biologics R&D, manufacturing, technological innovation, and operational management—WuXi Biologics utilizes its expertise to provide scalable, cost-effective, and efficient solutions tailored to client requirements. By integrating digital infrastructure throughout the biopharmaceutical value chain, the company transforms data and computation into transparent client experiences, accelerated development timelines, and optimized manufacturing processes. As of December 31, 2025, WuXi Biologics is managing 945 integrated client projects, with 74 in Phase III and 25 in commercial manufacturing, where complex modalities account for more than half of the total portfolio.

Sustainability is a core pillar of WuXi Biologics’ long-term strategy. The company consistently pursues technological innovation to provide advanced, green CRDMO solutions while upholding high Environmental, Social, and Governance (ESG) standards. Dedicated to creating shared value, the company works alongside stakeholders to drive positive social and environmental change and promote responsible practices across the entire value chain.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com

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SOURCE WuXi Biologics