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復星醫藥(600196.SH):子公司的藥品順鉑注射液獲得註冊申請受理

格隆匯9月7日丨復星醫藥(600196.SH)公佈,公司控股子公司吉斯美(武漢)製藥有限公司自主研發的順鉑注射液(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。

該新藥為本集團(即本公司及控股子公司/單位,下同)自主研發的化學藥品。該新藥擬(1)用於在已接受適當手術和/或放射治療的轉移性睾丸腫瘤患者中與其他批准的化療藥物建立聯合治療;(2)用於既往未接受過順鉑注射液治療且對標準化療難以治療的轉移性卵巢腫瘤患者的輔助治療,或在已接受適當手術和/或放射治療的轉移性卵巢腫瘤患者中與其他批准的化療藥物建立聯合治療(已建立的組合包括該新藥和環磷酰胺);(3)用於不再適合局部治療(如手術和/或放療)的移行性膀胱癌患者。

截至本公吿日,於中國境內(不包括港澳台地區,下同)已獲批上市的同類順鉑製劑主要包括江蘇豪森藥業集團有限公司的諾欣、齊魯製藥有限公司的注射用順鉑、雲南植物藥業有限公司的利艾康等。根據IQVIACHPA最新數據1,2022年,同類順鉑製劑於中國境內的銷售額約為人民幣1.24億元。截至2023年7月,本集團現階段針對該新藥的累計研發投入約為人民幣227萬元(未經審計)。

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