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Fosun subsidiary gets NMPA nod for lung cancer drug trial

September 8, 2025 at 10:39 AM UTCBy FilingReader AI

Shanghai Fosun Pharmaceutical (Group) Co. announced that its subsidiary, Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., received approval from the National Medical Products Administration (NMPA) for the clinical trial of Foritinib Succinate Capsules (SAF-189). This new class 1 chemical medicine is intended for the adjuvant treatment of stage IB to IIIA non-small cell lung cancer (NSCLC) with ALK-positive or ROS1-positive status following radical resection. Fosun Wanbang plans to commence Phase III clinical trials in China.

The new drug, developed through joint pre-clinical studies, has shown good clinical efficacy in patients with advanced ALK-positive NSCLC, including significant efficacy in central nervous system metastases. As of July 2025, the group has invested approximately RMB453 million in the research and development of the new drug. Drug registration applications for ALK-positive locally advanced or metastatic NSCLC have been accepted by the NMPA, and a Phase II clinical study for ROS1+ NSCLC has been completed.

According to IQVIA CHPA data, sales of major drugs for ALK-positive NSCLC in China were approximately RMB 3,164 million in 2024. The company reminds investors that drug R&D carries inherent risks, including potential termination of clinical trials due to safety or efficacy concerns, and that the launch process involves various uncertainties.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

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