WuXi Biologics (2269.HK) announced that 2 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 5-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 customised 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, 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 commercialisation 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."