Core Viewpoint - Fosun Pharma has received approval from the National Medical Products Administration for its self-developed drug, Luwo Meitini tablets, making it the first drug in China for the treatment of adult patients with Langerhans cell histiocytosis (LCH) [1][3] Group 1: Drug Approval and Indications - Luwo Meitini tablets are approved for two indications: treatment of adult patients with LCH and treatment of symptomatic, inoperable plexiform neurofibromas (PN) in children and adolescents aged 2 years and older with Neurofibromatosis Type 1 (NF1) [3] - LCH and Erdheim-Chester disease (ECD) are rare hematological tumors, with over 80% of patients affected by multi-system involvement, leading to severe symptoms and poor prognosis due to limited effective treatment options [1] Group 2: Mechanism of Action - Luwo Meitini tablets act as a highly selective MEK1/2 inhibitor, blocking the abnormal activation of the MAPK signaling pathway, thereby inhibiting tumor cell proliferation and inducing apoptosis [1] Group 3: Ongoing Clinical Trials - Fosun Pharma is expanding the indications for Luwo Meitini tablets, with ongoing Phase III clinical trials for adult NF1 in China and Phase II trials for low-grade gliomas, extracranial arteriovenous malformations, and pediatric LCH [3]
复星医药自研MEK抑制剂获批国内上市,这种罕见血液肿瘤有药可治了