上海君实生物医药科技股份有限公司 自愿披露关于全资子公司通过FDA现场检查的公告

Group 1 - The company’s subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., successfully passed an unannounced FDA CGMP inspection from June 16 to June 24, 2025, indicating ongoing international recognition of its high-quality manufacturing system [1][2] - The inspection report confirms that Suzhou Zhonghe has met the necessary standards for the production of its product, Toripalimab injection, which is crucial for its overseas commercialization efforts [1][2] - 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, enhancing its ability to supply the overseas market [1] Group 2 - The successful FDA inspection is a significant step for the company’s strategy to expand in the US market, providing a solid foundation for future growth and positively impacting its operations [2]