Zheng Quan Zhi Xing·2025-07-09 09:15Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has initiated a Phase III clinical trial for its self-developed drug, Rumaine (generic name: Luwomeitini tablets), aimed at treating pediatric low-grade glioma in mainland China [1][2]. Drug Information and Research Status - Rumaine is an innovative small molecule chemical drug that acts as a selective inhibitor of MEK1/2 [1]. - As of July 9, 2025, the drug is in Phase III clinical trials for treating pediatric low-grade glioma and is also in Phase II trials for treating extra-cranial arteriovenous malformations and pediatric Langerhans cell histiocytosis in mainland China [2]. - The drug has been included in the breakthrough therapy program by the National Medical Products Administration for two indications: inoperable or residual/recurrent NF1-related plexiform neurofibromas in adult patients and pediatric Langerhans cell histiocytosis [2]. - Cumulative R&D investment in the drug reached approximately RMB 607 million (unaudited) as of May 2025 [2]. - According to IQVIA MIDAS™, global sales of MEK1/2 selective inhibitors are projected to be approximately USD 2.068 billion in 2024 [2].