Shanghai Fosun Pharmaceutical (02196): Fu-Maining drug registration application accepted

Shanghai Fosun Pharmaceutical (02196) announced that its holding subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (Shanghai Fosun Pharmaceutical Industrial), has had its drug registration application for Pemigatinib (generic name: Lusutrombopag tablets; hereinafter referred to as "the drug") for the treatment of children aged 2 and above with Langherhans cell histiocytosis (LCH) accepted by the National Medical Products Administration (NMPA) and included in the priority review program. The drug has already been approved for two indications in China, including for the treatment of (1) LCH and tissue cell tumors in adult patients; (2) children and adolescents aged 2 and above with symptomatic, inoperable plexiform neurofibromas (PN) in Type I neurofibromatosis (NF1). The drug is currently in Phase III clinical trials for adults with Type I neurofibromatosis and children with low-grade gliomas in China, and in Phase II clinical trials for the treatment of extradural arteriovenous malformations in China. The drug for the treatment of inoperable or postoperative residual/recurrent NF1-related plexiform neurofibromas in adult patients has been included in the Breakthrough Therapy Drug Program by the NMPA Drug Evaluation Center. As of October 2025, the group's cumulative research and development investment for this drug is approximately RMB 638 million (unaudited). According to the latest IQVIA MIDAS data, sales of MEK1/2 selective inhibitors globally are expected to reach approximately $20.68 billion in 2024.