WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that two of its manufacturing facilities in Wuxi — Drug Substance Facility 2 (MFG2) and Drug Product Facility 1 (DP1) — together with its Drug Product Packaging Center (DPPC), have received GMP certification from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA). The certification positions WuXi Biologics to provide end‑to‑end commercial manufacturing services — covering both drug substance and drug product — for an anti-PD-L1 monoclonal antibody used in cancer immunotherapy.

Based on the five-day inspection, MFG2, DP1 and DPPC successfully passed ANVISA's assessment with zero findings. The inspection results demonstrate WuXi Biologics' robust quality management system, mature GMP execution, and efficient cross-functional collaboration, while verifying the company's comprehensive capabilities to support client needs for global commercial manufacturing and supply.

Within WuXi Biologics' global GMP manufacturing network, MFG2, DP1 and DPPC collectively provide integrated, end-to-end capabilities spanning large-scale biologics drug substance manufacturing, clinical and commercial drug product fill-finish, and customized packaging, meeting regulatory requirements across major markets worldwide. Together, these capabilities enable seamless manufacturing and reliable commercial supply for innovative biologic therapies.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Receiving ANVISA GMP certification reflects WuXi Biologics' continued commitment to global quality and compliance standards, and further validates our international standards across facilities, quality systems, and GMP execution. Looking ahead, we will continue to leverage our world-class quality system and end-to-end manufacturing capabilities to enable clients' global commercialization strategies, including entry into Latin America. By accelerating the delivery of high-quality, affordable biologics, we are helping to broaden access to innovative biologics for patients around the world."

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.