WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has again passed the GMP inspection by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its drug substance facilities (MFG2 and MFG5), in Wuxi city.

This onsite inspection covered the facilities' quality processes and the entire production system. It concluded without issues, demonstrating the company's robust expertise in meeting global regulatory requirements.

To date, WuXi Biologics has successfully passed 42 regulatory inspections and has received 97 license approvals from drug administration agencies across multiple countries and regions, including the U.S., Europe, China, Singapore, Japan and Canada. The company's track record of successful inspections underscores the reliability and full compliance of its quality system with global regulatory standards.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Our world-class quality system is the cornerstone to maintain the company's strong sustainable growth and has laid a solid foundation for our global network to support our clients worldwide. WuXi Biologics will continue to enable global partners in delivering life-saving treatments with speed and efficacy, ultimately benefiting patients worldwide."