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MEK1/2选择性抑制剂
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复星医药芦沃美替尼片新增适应症临床试验获批
Bei Jing Shang Bao· 2026-02-25 10:10
根据公告,芦沃美替尼片为MEK1/2选择性抑制剂。目前,该药品已于中国境内(不含港、澳、台地 区)上市并获批两项适应症,包括用于治疗朗格汉斯细胞组织细胞增生症(LCH)和组织细胞肿瘤成人 患者以及2岁及2岁以上伴有症状、无法手术的丛状神经纤维瘤(PN)的Ⅰ型神经纤维瘤病(NF1)儿 童及青少年患者。 北京商报讯(记者 王寅浩 宋雨盈)2月25日,复星医药发布公告称,公司控股子公司上海复星医药产业 发展有限公司收到国家药品监督管理局关于同意复迈宁®(通用名:芦沃美替尼片)联合安罗替尼用于 鼠类肉瘤病毒癌基因(KRAS)突变的晚期非小细胞肺癌(NSCLC)患者开展临床试验的批准。复星医 药产业拟于条件具备后开展该药品的Ⅱ期临床试验。 ...
上海复星医药(集团)股份有限公司关于控股子公司药品注册申请获受理的公告
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].