復星醫藥(02196.HK)控股子公司獲藥品註冊申請受理
格隆匯6月6日丨復星醫藥(02196.HK)公吿,上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司上海復星醫藥產業發展有限公司自主研發的復邁替尼片(項目代號:FCN-159片,以下簡稱“該新藥”)用於治療2歲及2歲以上兒童1型神經纖維瘤病(NF1)相關的叢狀神經纖維瘤(PN)的藥品註冊申請於近日獲國家藥品監督管理局(以下簡稱“國家藥監局”)受理並已被納入優先審評程序。
該新藥為集團(即公司及控股子公司/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,擬主要用於晚期實體瘤、1型神經纖維瘤、樹突狀細胞和組織細胞腫瘤、低級別腦膠質瘤等的治療。
截至2024年4月,集團現階段針對該新藥累計研發投入約為人民幣49,915萬元(未經審計)。
截至本公吿日,該新藥用於治療成人樹突狀細胞和組織細胞腫瘤的藥品註冊申請已獲國家藥監局受理並被納入優先審評程序;該新藥用於治療成人1型神經纖維瘤於中國境內(不包括港澳台地區,下同)處於III期臨牀試驗階段,該新藥用於低級別腦膠質瘤、動靜脈畸形、兒童朗格漢斯細胞組織細胞增生症的治療於中國境內分別處於II期臨牀試驗階段;其中,該新藥用於治療組織細胞腫瘤、成人1型神經纖維瘤兩項適應症已分別被國家藥監局藥品評審中心納入突破性藥物治療程序。
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