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復星醫藥(600196.SH):重組抗CTLA-4全人單克隆抗體注射液獲藥品臨牀試驗通知書
格隆匯 04-08 20:38

格隆匯4月8日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復宏漢霖生物技術股份有限公司(“復宏漢霖”)及上海復宏漢霖生物製藥有限公司(“漢霖製藥”)收到國家藥品監督管理局關於同意其研製的重組抗CTLA-4全人單克隆抗體注射液(生物類似藥,即HLX13;“該新藥”)用於無法切除或轉移性黑色素瘤、晚期腎細胞癌、微衞星高度不穩定性或錯配修復缺陷的轉移性結直腸癌治療以及黑色素瘤輔助治療開展臨牀試驗的通知書。復宏漢霖及漢霖製藥擬於近期條件具備後於中國境內(不包括港澳台地區,下同)開展該新藥的臨牀I期試驗。

該新藥為集團自主研發的伊匹木單抗生物類似藥,主要用於無法切除或轉移性黑色素瘤、晚期腎細胞癌、微衞星高度不穩定性或錯配修復缺陷的轉移性結直腸癌治療以及黑色素瘤輔助治療。

截至公告日,於全球上市的CTLA-4靶點的單克隆抗體藥品為Bristol-Myers SquibbYervoy®(Ipilimumab),於中國境內尚無同靶點的同類藥物上市。根據IQVIAMIDASTM最新數據(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商),2019年度,Yervoy®(Ipilimumab)於全球銷售額約15.23億美元。

截至20203月,集團現階段針對該新藥累計研發投入人民幣2422(未經審計)

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