人福医药集团股份公司关于HW221043片获得药物临床试验批准通知书的公告

Core Viewpoint - The company has received approval for clinical trials of HW221043 tablets, a new molecular entity aimed at treating advanced solid tumors, marking a significant step in its drug development process [1][2]. Group 1: Drug Development - The drug HW221043 is classified as a Class 1 chemical drug and is intended for clinical trials in patients with advanced solid tumors [1]. - The total research and development investment for HW221043 has reached approximately 24 million RMB [2]. - The company plans to initiate clinical research following the receipt of the clinical trial approval and will submit trial data to the National Medical Products Administration for production approval after completion [2]. Group 2: Regulatory Approval - The National Medical Products Administration has granted the clinical trial approval for HW221043, confirming that it meets the necessary registration requirements [1]. - The approval was based on the review conducted on October 29, 2025, allowing the drug to proceed with clinical trials [1].