Core Viewpoint - The company, 汇宇制药 (688553.SH), 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 - The FDA conducted inspections from October 27, 2025, to November 6, 2025, and the company received the Establishment Inspection Report (EIR) confirming the completion of the inspection [1] - This inspection marks the third time the company has undergone an FDA site inspection, indicating a consistent compliance with regulatory standards [1] - The successful completion of the cGMP and PAI inspections enhances the company's production management quality system and operational compliance, which is essential for expanding its market presence in the U.S. [1] Group 2 - The positive outcome of the inspections is expected to have a favorable impact on the company's future operating performance and improve its competitiveness in international markets [1] - The inspections provide a solid foundation for the company's ongoing and healthy development in the pharmaceutical industry [1]