WuXi Biologics (HK:2269), a China-based global Contract Research, Development, and Manufacturing Organisation (CRDMO), announced on Thursday that three of its manufacturing facilities in Wuxi – Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2), and Drug Product Packaging Center (DPPC) – have received GMP certification from South Korea's Ministry of Food and Drug Safety (MFDS).

This certification positions WuXi Biologics to provide end-to-end commercial manufacturing services, covering both drug substance and drug product, for a bispecific antibody indicated for the treatment of biliary tract cancer.

During a five-day on-site inspection, all three facilities successfully passed the MFDS assessment with no critical or major findings.

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 customised packaging, enabling commercial supply of innovative biologic therapies.

Wuxi said that as of the end of 2025 the company has successfully passed 46 regulatory inspections, including 22 conducted by the FDA and EMA, and secured 136 facility licence approvals.