Core Viewpoint - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., has had its drug registration application for Rumaine (generic name: Luwomeitini tablets) accepted by the National Medical Products Administration, which has been included in the priority review process for treating children aged 2 and above with Langerhans cell histiocytosis (LCH) [2][4]. Group 1 - The drug is an innovative small molecule chemical drug developed by the group, specifically a selective MEK1/2 inhibitor [3]. - As of November 21, 2025, the drug has been approved for two indications in mainland China: treatment of LCH and adult patients with histiocytosis, and treatment of symptomatic, inoperable plexiform neurofibromas in children and adolescents aged 2 and above with Neurofibromatosis Type 1 (NF1) [4]. - The drug is currently in Phase III clinical trials for treating adult NF1 and pediatric low-grade gliomas, and in Phase II trials for treating extra-cranial arteriovenous malformations [4]. Group 2 - The cumulative R&D investment for the drug as of October 2025 is approximately RMB 638 million (unaudited) [5]. - According to IQVIA MIDAS data, the global sales of MEK1/2 selective inhibitors are projected to be approximately USD 2.068 billion in 2024 [5].