Shanghai Junshi Biosciences Co., Ltd. (Stock code: 1877) reported that its wholly-owned subsidiary, Suzhou Union Biopharm Co., Ltd., recently passed an unannounced Current Good Manufacturing Practice (CGMP) inspection conducted by the U.S. Food and Drug Administration (FDA) at the Suzhou Wujiang Production Base from 16 June 2025 to 24 June 2025. Official confirmation was received through the Establishment Inspection Report issued by the FDA.

Suzhou Union’s facility underwent its second successful FDA on-site inspection since the initial clearance in 2023. The inspection focused on toripalimab injection and further validates the high-quality manufacturing system of Shanghai Junshi Biosciences. With a fermentation capacity of 4,500L (9×500L), the Suzhou Wujiang Production Base holds GMP certifications and approvals from numerous international jurisdictions, including Chinese mainland, Hong Kong SAR, the United States, the European Union, and several other regions. The facility is responsible for supplying toripalimab to overseas markets.

According to the announcement, the U.S. market remains a crucial component of the company’s overseas commercialization strategy. This successful FDA inspection is expected to bolster the company’s expansion in the U.S. market and have a positive impact on its production and operations. However, the announcement also indicates that results may be influenced by broader market factors, advising cautious decision-making regarding investment risks.