復星醫藥(600196.SH):蘆沃美替尼片獲藥品註冊批准
格隆匯5月29日丨復星醫藥(600196.SH)公佈,公司控股子公司上海復星醫藥產業發展有限公司就蘆沃美替尼片(商品名:復邁寧;項目代號:FCN-159;以下簡稱“該新藥”)的上市註冊申請獲國家藥品監督管理局(以下簡稱“國家藥監局”)批准,本次獲批適應症包括用於治療(1)朗格漢斯細胞組織細胞增生症(LCH)和組織細胞腫瘤成人患者;(2)2歲及2歲以上伴有症狀、無法手術的叢狀神經纖維瘤(PN)的Ⅰ型神經纖維瘤病(NF1)兒童及青少年患者。
該新藥為本集團(即本公司及控股子公司/單位,下同)自主研發的創新型小分子化學藥物,為MEK1/2選擇性抑制劑。
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