復星醫藥(02196.HK)：丁二酸復瑞替尼膠囊藥品註冊申請於近日獲國家藥品監督管理局受理
格隆匯3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”)控股子公司復星萬邦(江蘇)醫藥集團有限公司(以下簡稱“復星萬邦”)就丁二酸復瑞替尼膠囊(項目代號：SAF-189，申請註冊分類：化藥1類；以下簡稱“該新藥”)的藥品註冊申請於近日獲國家藥品監督管理局受理。
該新藥為創新型小分子化學藥物，擬主要用於治療非小細胞肺癌(ALK+)、非小細胞肺癌(ROS1+)等，本次申報適應症為用於間變性淋巴瘤激酶(ALK)陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)患者的治療。
該新藥由公司控股子公司重慶復創醫藥研究有限公司與中國科學院上海藥物研究所共同進行臨牀前研究，並獨家許可復星萬邦就該新藥於中國境內(不包括港澳台地區，下同)進行獨家開發(包括但不限於臨牀試驗、上市註冊等)和商業化。截至目前的臨牀研究顯示，該新藥在ALK陽性的非小細胞肺癌晚期患者中，展現出良好的臨牀療效，對中樞神經系統轉移灶療效顯著，且安全性良好。截至本公吿日期(即2025年3月6日)，該新藥的另一適應症用於治療非小細胞肺癌(ROS1+)於中國境內已完成II期臨牀研究。
截至2025年1月，集團(即公司及控股子公司/單位，下同)現階段針對該新藥的累計研發投入約為人民幣4.39億元(未經審計)。
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