智通财经网·2025-10-22 10:19Core Insights - 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, indicating compliance with current good manufacturing practices [1][2] Group 1 - This marks the second successful FDA inspection for Suzhou Zhonghe since its first in 2023, demonstrating the company's high-quality manufacturing system continues to receive international recognition [2] - As of the announcement date, the Suzhou Wujiang production base has a fermentation capacity of 4,500 liters (9*500 liters) and 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 [2] - The successful FDA inspection is a significant component of the company's overseas commercialization strategy, particularly for the US market, providing a solid foundation for continued expansion in this region and positively impacting the company's operations [2]