Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for the novel small-molecule drug candidate FCN-159, granting it priority review status. The filing seeks approval for the treatment of plexiform neurofibroma (PN) associated with type 1 neurofibromatosis (NF1) in pediatric patients aged 2 years and above.
FCN-159 is a highly selective MEK1/2 inhibitor under development for the treatment of advanced solid tumors, type I neurofibroma, and histiocyte tumors. In May 2024, the company had submitted a market approval filing for FCN-159 for the treatment of dendritic and histiocytic tumors, which was also accepted by the NMPA with priority review status. Furthermore, the drug has received breakthrough therapy designations (BTDs) from the bureau for its potential use in histiocyte tumors and adult type I neurofibroma.- Flcube.com
