四川汇宇制药股份有限公司关于自愿披露通过美国FDA现场检查的公告

Group 1 - The company, Sichuan Huiyu Pharmaceutical Co., Ltd., successfully passed the FDA's current Good Manufacturing Practice (cGMP) inspection and Pre-Approval Inspection (PAI) conducted from October 27, 2025, to November 6, 2025 [1] - The inspection covered the production of active pharmaceutical ingredients, sterile active pharmaceutical ingredients, small-volume injections, lyophilized powder, and sterile powders [1] - The FDA issued a Voluntary Action Indicated (VAI) conclusion, indicating that the company needs to take voluntary corrective actions [1] Group 2 - This inspection marks the third time the company has undergone an FDA inspection, confirming that its production lines for anti-tumor injectables and active pharmaceutical ingredients meet FDA requirements [1] - The successful inspection is expected to positively impact the company's future operating performance and enhance its competitiveness in the international market [1]