上海復星醫藥(02196.HK)關於控股子公司藥品獲臨牀試驗批準
格隆匯9月8日丨上海復星醫藥(02196.HK)公告,控股子公司復星萬邦(江蘇)醫藥集團有限公司於近期收到國家藥品監督管理局(以下簡稱“國家藥監局”)關於同意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”)用於間變性淋巴瘤激酶(ALK)陽性或者c-ros肉瘤致癌因子-受體酪氨酸激酶(ROS1)陽性的IB期至ⅢA期非小細胞肺癌患者腫瘤根治性切除術後的輔助治療開展臨牀試驗的批準。復星萬邦擬於條件具備後於中國境內開展該新藥的Ⅲ期臨牀試驗
截至2025年7月,針對該新藥的累計研發投入約爲人民幣4.53億元(未經審計)。根據IQVIACHPA最新數據1,2024年,於中國境內用於治療非小細胞肺癌(ALK+)的主要藥品的銷售額約爲人民幣31.64億元。
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