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]

Core Viewpoint - The company, Huyou Pharmaceutical, successfully passed the FDA's current Good Manufacturing Practice (cGMP) inspection and Pre-Approval Inspection (PAI), which is crucial for its operations in the U.S. market [1] Group 1: FDA Inspection Results - The company underwent the FDA inspection from October 27, 2025, to November 6, 2025, and received the Establishment Inspection Report (EIR) confirming the completion of the inspection [1] - This inspection marks the third time the company has been evaluated by the FDA, indicating a consistent compliance with regulatory standards [1] Group 2: Impact on Business Operations - The successful completion of the cGMP and PAI inspections ensures that the company's production lines for anti-tumor injectables and active pharmaceutical ingredients meet FDA requirements [1] - This achievement is expected to positively influence the company's future operating performance and enhance its competitiveness in international markets [1] - The inspection results provide a solid foundation for the company's ongoing expansion in the U.S. market, supporting its sustainable and healthy development [1]