智通财经网·2025-11-21 10:08Core Viewpoint - Fosun Pharma's subsidiary has received acceptance for a drug registration application for the treatment of Langerhans cell histiocytosis (LCH) in children aged 2 and above, which has been included in the priority review process by the National Medical Products Administration (NMPA) [1] Group 1: Drug Development and Approval - The drug, Rumaine (generic name: Luwomeitini tablets), is already approved in China for two indications: treatment of LCH in adults and treatment of symptomatic, inoperable plexiform neurofibromas in children and adolescents with Neurofibromatosis Type 1 (NF1) [1] - The drug is currently in Phase III clinical trials for the treatment of adult NF1 and low-grade gliomas in children, and in Phase II clinical trials for the treatment of extra-cranial arteriovenous malformations [1] - The NMPA has included the drug for the treatment of inoperable or residual/recurrent NF1-related plexiform neurofibromas in adults in its breakthrough therapy program [1] Group 2: Financial Investment and Market Potential - 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 approximately USD 2.068 billion in 2024 [2]