复星医药(02196)控股子公司药品获临床试验批准
智通财经网·2026-02-25 09:54

Core Viewpoint - Fosun Pharma has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its drug, Rumaine (generic name: Luwomeitini tablets), in combination with Anlotinib for advanced non-small cell lung cancer (NSCLC) patients with KRAS mutations [1] Group 1 - The drug is an innovative small molecule chemical drug developed by the company, acting as a selective inhibitor of MEK1/2 [1] - The company plans to initiate Phase II clinical trials for the drug in China once conditions are met [1] Group 2 - As of February 25, 2026, the drug has been approved for two indications in China: treatment of Langerhans cell histiocytosis (LCH) and treatment for symptomatic, inoperable plexiform neurofibromas (PN) in children and adolescents aged 2 years and older with Neurofibromatosis type 1 (NF1) [2] - Two additional drug application submissions for the drug have been accepted by the NMPA and included in the priority review process for treating LCH in children aged 2 years and older and for treating symptomatic, inoperable PN in adults with NF1 [2] - The drug is currently in Phase III clinical trials for treating pediatric low-grade gliomas and in Phase II clinical trials for treating extracranial arteriovenous malformations in China [2] - The cumulative R&D investment for the drug as of January 2026 is approximately RMB 668 million (unaudited) [2] - According to IQVIA MIDAS™, the global sales of MEK1/2 selective inhibitors are projected to be approximately USD 2.068 billion in 2024 [2]

FOSUNPHARMA-复星医药(02196)控股子公司药品获临床试验批准 - Reportify