Fosun Pharma's subsidiary drug granted breakthrough therapy designation

Shanghai Fosun Pharmaceutical (Group) Co. (HKEX: 2196) announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Company Limited, has received breakthrough therapy designation from China's National Medical Products Administration (NMPA) for its innovative drug, FCN-159 tablets. This designation is specifically for treating children diagnosed with Langerhans cell histiocytosis. The drug, a MEK1/2 selective inhibitor, is also being developed for advanced solid tumors, neurofibromatosis type 1, and other neoplasms. The company has invested approximately RMB598 million in the R&D of the New Drug. As of May 12, 2025, the drug registration applications for the treatment of adult dendritic cell and histiocytic neoplasms, and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) -associated plexiform neurofibromas (PN), have been accepted by the NMPA and included in the List of Priority Review. The announcement cautioned investors about the inherent risks involved in drug development and clinical trials.