Zhi Tong Cai Jing·2025-11-21 10:02Core Insights - Fosun Pharma's subsidiary has received acceptance for a drug registration application for Luvofatin (复迈宁) to treat pediatric patients with Langerhans Cell Histiocytosis (LCH) aged 2 and above, which is now included in the priority review process by the National Medical Products Administration (NMPA) [1] - The drug is already approved in China for two indications: treating LCH in adults and symptomatic, inoperable plexiform neurofibromas in children and adolescents with Neurofibromatosis Type 1 (NF1) [1] - The drug is currently in Phase III clinical trials for treating adult NF1 and low-grade gliomas in children, and in Phase II trials for treating extra-cranial arteriovenous malformations [1] - The drug has been included in the breakthrough therapy program for adult patients with inoperable or residual/recurrent NF1-related plexiform neurofibromas by the NMPA [1] Financial Insights - As of October 2025, the cumulative R&D investment for the drug is approximately RMB 638 million (unaudited) [2] - According to IQVIA MIDAS data, the global sales for MEK1/2 selective inhibitors are projected to be around USD 2.068 billion in 2024 [2]