Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for the novel small-molecule drug FCN-159 for review. The drug is being considered for the treatment of dendritic and histiocytic tumors, indications that have previously been granted priority review status by the NMPA.
FCN-159 is a highly selective MEK1/2 inhibitor under development for the treatment of advanced solid tumors, type I neurofibroma, and histiocyte tumors, among other conditions. It is currently in a Phase III study for type I neurofibroma and Phase II studies for type I neurofibroma in children, low-grade gliomas, arteriovenous malformations, and Langerhans cell histiocytosis in pediatric patients in China. The NMPA has previously awarded breakthrough therapy designations (BTDs) for the drug’s use in histiocytic tumors and adult type I neurofibroma.- Flcube.com
