Wuxi, ChinaApril 23, 2026 /PRNewswire/ — WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that its three manufacturing facilities in Wuxi — Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2), and Drug Product Packaging Center (DPPC) — have received Good Manufacturing Practice (GMP) certification from the Ministry of Food and Drug Safety (MFDS) of South Korea. These facilities will provide end-to-end commercial manufacturing services, covering both drug substance and drug product, for a bispecific antibody used in the treatment of biliary tract cancer.
During the five-day inspection, all three facilities successfully passed the MFDS evaluation with zero critical findings and zero major findings, fully demonstrating WuXi Biologics’ rigorous quality and compliance systems, as well as its GMP compliance execution capabilities in large-scale manufacturing projects for complex biologics.
Each of the three facilities that passed the inspection holds distinct advantages within WuXi Biologics’ global manufacturing network. MFG5 specializes in large-scale drug substance production for biologics, offering stable capacity to support commercial supply. DP2 provides drug product manufacturing capabilities covering both clinical and commercial stages. DPPC offers clients end-to-end customized packaging solutions that meet regulatory requirements of major global markets. Leveraging the coordinated operations of WuXi Biologics’ global GMP manufacturing network, these facilities can provide efficient, integrated end-to-end manufacturing support for innovative biologics.
Dr. Chris Chen, CEO of WuXi Biologics, stated: “The GMP certification from MFDS for these three facilities underscores our unwavering commitment to the highest global quality and compliance standards. This not only expands our ability to serve markets in South Korea and the Asia-Pacific region but also validates our expertise and systemic advantages in the development and commercial manufacturing of complex biologics, such as bispecific antibodies. Moving forward, we will continue to uphold world-class quality systems and end-to-end manufacturing capabilities, working with partners to accelerate the delivery of innovative biologics to patients worldwide.”
WuXi Biologics consistently adheres to stringent industry quality standards and maintains an exceptional quality record. As of the end of December 2025, the company has successfully passed 46 regulatory inspections, including 22 FDA and EMA inspections, and has received 136 facility license approvals. It has maintained a 100% pass rate in FDA Pre-License Inspections (PLI). Additionally, the company has passed over 1,800 GMP quality audits from global clients, including more than 230 audits by EU Qualified Persons. Currently, WuXi Biologics operates 15 GMP-certified drug substance and drug product manufacturing facilities worldwide, with its world-class quality system and compliance capabilities serving as the foundation of client trust.
About WuXi Biologics
WuXi Biologics (Stock Code: 2269.HK) is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO). Through its open, integrated biologics capabilities and technology enablement platform, the company offers comprehensive end-to-end services to help partners discover, develop, and manufacture biologics, from concept to commercial production. This accelerates the global biologics R&D process, reduces R&D costs, and benefits patients worldwide.
Leveraging its global network connecting China, the United States, Ireland, Germany, and Singapore, WuXi Biologics brings together over 13,000 employees, including industry experts and scientists in biologics R&D and manufacturing, technological innovation, and operational excellence. With its leading technology platforms and deep expertise, the company provides efficient, cost-effective, and scalable biologics solutions tailored to meet client needs at different stages. Furthermore, the company systematically integrates digital capabilities and infrastructure into the full value chain of biologics R&D, laboratory operations, and manufacturing, transforming data, computing, and predictive capabilities into more transparent client collaboration experiences, faster R&D processes, smarter operational management, and more efficient production delivery. As of the end of December 2025, WuXi Biologics is supporting a total of 945 integrated client projects, including 74 Phase III and 25 commercial manufacturing projects, with complex molecule projects accounting for over 50% of the company’s total project portfolio.
WuXi Biologics regards sustainable development as the cornerstone of its long-term business growth. The company continues to promote green innovation technologies, providing global partners with advanced end-to-end green CRDMO solutions while achieving outstanding ESG performance. Upholding the philosophy of creating shared value, the company collaborates with stakeholders to build a sustainable development ecosystem, driving both social value and ecological benefits through responsible operational models, thereby achieving synergistic empowerment across the full value chain.
For more information, please visit: www.wuxibiologics.com.
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