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WuXi Biologics (2269.HK) said three manufacturing facilities in Wuxi—Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2), and the Drug Product Packaging Center (DPPC)—have received GMP certification from South Korea’s Ministry of Food and Drug Safety (MFDS). The certification enables the company to provide end-to-end commercial manufacturing services for a bispecific antibody indicated for the treatment of biliary tract cancer, covering both drug substance and drug product.
During a five-day on-site inspection, all three facilities passed the MFDS assessment with no critical or major findings. WuXi Biologics said the result reaffirms its quality and compliance systems and its capability to carry out GMP-compliant large-scale manufacturing for complex biologic programs.
Within WuXi Biologics’ global GMP manufacturing network, MFG5, DP2 and DPPC collectively provide integrated, end-to-end capabilities spanning drug substance manufacturing, drug product fill-finish, and customized packaging. The company said this setup supports efficient commercial supply of biologic therapies.
Dr. Chris Chen, CEO of WuXi Biologics, said: “Receiving GMP certification from the MFDS demonstrates our continued commitment to the global standards of quality and regulatory compliance. It further strengthens our support for customers across South Korea and the Asia-Pacific region, while reaffirming our proven domain expertise and systematic strengths in the development and commercial manufacturing of complex biologics, including bispecific antibodies. We will continue to build on our world-class quality system and end-to-end manufacturing capabilities to enable partners to accelerate the delivery of innovative biologics to patients worldwide.”
WuXi Biologics cited its regulatory and quality performance. As of the end of 2025, the company said it has passed 46 regulatory inspections, including 22 by the FDA and EMA, and secured 136 facility license approvals. It also reported a 100% pass rate for FDA Pre-License Inspection (PLI).
The company added that it has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons. WuXi Biologics currently operates 15 GMP-certified drug substance and drug product facilities within its global network.
WuXi Biologics (2269.HK) is a contract research, development and manufacturing organization (CRDMO) providing end-to-end solutions to help partners discover, develop and manufacture biologics—from concept to commercialization.
The company said it has over 13,000 employees across China, the United States, Ireland, Germany, and Singapore, including experts and scientists in biologics R&D and manufacturing. It also stated that, as of December 31, 2025, it is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of its project portfolio.
WuXi Biologics said sustainability is central to its long-term growth strategy, offering “Green CRDMO” solutions and emphasizing Environmental, Social and Governance (ESG) practices.
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