Junshi Biosciences subsidiary passes second FDA on-site inspection

Suzhou Union Biopharm Co., Ltd., a wholly-owned subsidiary of Shanghai Junshi Biosciences Co., Ltd., recently passed an unannounced Current Good Manufacturing Practice (CGMP) on-site inspection by the U.S. Food and Drug Administration (FDA). The inspection took place from June 16, 2025, to June 24, 2025, at its Wujiang Production Base in Suzhou, and the company has since received the Establishment Inspection Report (EIR) confirming its success. The underlying product for this inspection was Toripalimab injection.

This marks Suzhou Union's second successful FDA on-site inspection, building on its initial success in 2023. The achievement highlights the company's consistent high-quality production and manufacturing system, which continues to gain international recognition. The Suzhou Wujiang Production Base holds GMP certifications and approvals from various countries including the Chinese mainland, the United States, the European Union, and the United Kingdom, among others.

The successful inspection is deemed a solid foundation for Junshi Biosciences' continued expansion in the U.S. market, supporting its overseas commercialization strategy and positively impacting production and operations. The company stated that while the inspection's short-term impact on results is not expected to be significant, it advises investors to exercise caution due to inherent market and operational uncertainties in drug production and sales.