Fosun Pharma subsidiary withdraws drug application, plans quick resubmission

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced its controlled subsidiary, Fosun Wand Pharmaceutical Group (Jiangsu) Co., Ltd. (Fosun Wand), received notification from the National Medical Products Administration (NMPA) to withdraw its registration application for Dihydrogen Fumarate Furetinib Capsules (project code: SAF-189). This innovative small molecule chemical drug is for the treatment of non-small cell lung cancer (ALK+), non-small cell lung cancer (ROS1+), and specifically for ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients. The application was initially accepted by the NMPA in March 2025.

Fosun Pharma clarified that the withdrawal does not signify the termination of the project. Fosun Wand plans to further refine its registration materials based on the latest technical requirements from the NMPA and intends to re-submit the drug registration application promptly. The company also stated that this withdrawal will not have a significant impact on the group's current period performance.

The company reminded investors that drug research and development and subsequent listing are long-term endeavors, subject to various uncertainties, and advised investors to be mindful of investment risks.