Ge Long Hui·2025-10-22 11:01Core Points - Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Junshi Biosciences, successfully passed an unannounced CGMP inspection by the FDA from June 16 to June 24, 2025, marking the second successful inspection since 2023 [1] - The successful inspection indicates that the company's high-quality manufacturing system continues to receive international recognition [1] - The Suzhou Wujiang production base has a fermentation capacity of 4,500 liters and has obtained GMP certifications from multiple countries and regions, including the US, EU, and Australia, primarily for the commercialization supply of Toripalimab in overseas markets [1] Business Impact - The successful FDA inspection is a significant component of the company's overseas commercialization strategy, providing solid assurance for the continued expansion into the US market [2] - This achievement is expected to have a positive impact on the company's production and operations [2]