君实生物子公司通过FDA现场检查

Core Viewpoint - Junshi Biosciences (01877) announced that its wholly-owned subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., successfully passed an unannounced CGMP inspection by the FDA, indicating the company's high-quality manufacturing system continues to gain international recognition [1] Group 1: FDA Inspection - Suzhou Zhonghe underwent an unannounced CGMP inspection from June 16 to June 24, 2025, and received a favorable Establishment Inspection Report (EIR) from the FDA [1] - This marks the second successful FDA inspection for Suzhou Zhonghe since its first in 2023, reinforcing the company's commitment to quality [1] Group 2: Production Capacity and Certifications - As of the announcement date, the Suzhou Wujiang production facility has a fermentation capacity of 4,500 liters (9 x 500 liters) [1] - The facility has obtained GMP certifications and approvals from multiple countries and regions, including mainland China, Hong Kong, the USA, EU, UK, Australia, Singapore, India, Jordan, UAE, Kuwait, and Pakistan [1] Group 3: Market Implications - The successful FDA inspection is crucial for the company's strategy to expand in the US market, providing a solid foundation for ongoing commercial supply of Toripalimab [1] - This development is expected to have a positive impact on the company's production and operations [1]