WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced 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 Ministry of Food and Drug Safety (MFDS). The 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 the five‑day on‑site inspection, all three facilities successfully passed the MFDS assessment with no critical or major findings, reaffirming WuXi Biologics' robust quality and compliance systems, as well as its proven capability to execute 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, enabling efficient commercial supply of innovative biologic therapies.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "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 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 15 GMP-certified drug substance and drug product facilities within its global network. Its world-class quality and compliance capabilities underpin long-standing trust from clients worldwide.