Core Viewpoint - Fosun Pharma's subsidiary has received approval from the National Medical Products Administration to conduct clinical trials for the drug Rumaine (generic name: Luwotametin tablets) in combination with Anlotinib for advanced non-small cell lung cancer patients with KRAS mutations [1] Group 1 - The drug Luwotametin is a selective MEK1/2 inhibitor [1] - Luwotametin has already been approved for two indications in mainland China, including treatment for Langerhans cell histiocytosis (LCH) and for pediatric patients with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1 (NF1) [1] - The company plans to initiate Phase II clinical trials for the drug once conditions are met [1]

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].