智通财经网·2025-11-21 09:57Core Viewpoint - Fosun Pharma's subsidiary has received acceptance for a drug registration application for Rumaine (generic name: Luwomeitini tablets) to treat children aged 2 and above with Langerhans cell histiocytosis (LCH), which is now included in the priority review process by the National Medical Products Administration (NMPA) [1] Group 1: Drug Development and Approval - The drug has already been approved in China for two indications: treatment of LCH and adult patients with tissue cell tumors, and treatment of symptomatic, inoperable plexiform neurofibromas (PN) 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 clinical trials for treating extra-cranial arteriovenous malformations [1] - The drug for treating inoperable or residual/recurrent NF1-related plexiform neurofibromas in adult patients has been included in the breakthrough therapy program by the NMPA [1] Group 2: Financial Investment and Market Potential - As of October 2025, the cumulative R&D investment for this drug is approximately RMB 638 million (unaudited) [2] - According to IQVIA MIDAS™ data, the global sales of MEK1/2 selective inhibitors are projected to be approximately USD 2.068 billion in 2024 [2]