Shanghai Fosun Pharmaceutical's subsidiary received acceptance for the registration application of the drug Luvomegitinib tablets (600196.SH).

Shanghai Fosun Pharmaceutical (600196.SH) announced that its controlled subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (hereinafter referred to as "Shanghai Fosun Pharmaceutical Industrial"), has had its drug registration application for Futemn (generic name: lusutemnib tablets; hereinafter referred to as "the drug") for the treatment of children patients aged 2 years and above with Langerhans cell histiocytosis (LCH) (hereinafter referred to as "new indication") accepted by the National Medical Products Administration (hereinafter referred to as "NMPA") and included in the priority review program. The drug is an innovative small molecule chemical drug independently developed by the group, which is a selective inhibitor of MEK1/2. As of the date of this announcement (November 21, 2025), the drug's other registration or clinical situations are as follows: 1. The drug has been approved for two indications on the market in China, including the treatment of (1) Langerhans cell histiocytosis (LCH) and tissue cell tumor in adult patients; (2) Children and adolescents aged 2 years and above with symptoms and unable to undergo surgery with symptomatic, non-surgical plexiform neurofibromas (PN) in Type 1 neurofibromatosis (NF1). 2. The drug is in Phase III clinical trials for the treatment of adult Type 1 neurofibromatosis, and children with low-grade gliomas in China, and in Phase II clinical trials for the treatment of extracranial arteriovenous malformations in China. In particular, the drug for treating adult patients with NF1-related plexiform neurofibromas who are unable to undergo surgery or have postoperative residual/recurrence has been included in the breakthrough therapy drug program by the NMPA Drug Evaluation Center.