Zhi Tong Cai Jing·2025-11-21 11:16Core Viewpoint - Fosun Pharma's subsidiary has received acceptance for a drug registration application for a new indication of a medication used to treat Langerhans cell histiocytosis in children aged 2 and above, which has been prioritized for review by the National Medical Products Administration [1] Group 1: Drug Development and Approval - The drug, known as Rumaine (generic name: Lenvatinib), has already been approved in China for two indications: treatment of LCH and adult patients with tissue tumors, and for symptomatic, inoperable plexiform neurofibromas in children and adolescents with Neurofibromatosis type I [1] - The drug is currently in Phase III clinical trials for treating adult Neurofibromatosis type I 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 by the National Medical Products Administration for treating inoperable or residual/recurrent plexiform neurofibromas in adult patients [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 around USD 2.068 billion in 2024 [2]