复星医药(02196.HK):复星万邦撤回丁二酸复瑞替尼胶囊注册申请,将完善资料后重新提交
Ge Long Hui·2025-10-14 09:44

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanguo, has withdrawn the registration application for the innovative drug SAF-189 (Dibutyl Succinate Reversitin Capsules) intended for treating non-small cell lung cancer (ALK+ and ROS1+) [1] Group 1: Company Actions - Fosun Wanguo received a notification from the National Medical Products Administration (NMPA) regarding the withdrawal of the registration application for SAF-189 [1] - The withdrawal is not a termination of the project; Fosun Wanguo plans to improve the registration materials according to the latest technical requirements from the NMPA and will resubmit the application as soon as possible [1] - The withdrawal of the registration application will not have a significant impact on the current performance of the group, which includes the company and its subsidiaries [1] Group 2: Drug Information - SAF-189 is an innovative small molecule chemical drug primarily aimed at treating ALK-positive and ROS1-positive non-small cell lung cancer [1] - The drug's registration application for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with ALK positivity was accepted by the NMPA in March 2025 [1]