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復星醫藥(600196.SH):子公司開展SVN53-67/M57-KLH肽疫苗II期臨牀試驗獲批

格隆匯3月18日丨復星醫藥(600196.SH)公佈,近日,上海復星醫藥(集團)股份有限公司控股子公司上海復星醫藥產業發展有限公司(簡稱“復星醫藥產業”)收到國家藥品監督管理局關於同意其獲許可引進的SVN53-67/M57-KLH肽疫苗(即SurVaxM,簡稱“該新藥”)聯合替莫唑胺輔助治療初診的膠質母細胞瘤開展臨牀試驗的批准。復星醫藥產業擬於條件具備後於中國境內(不包括港澳台,下同)開展該新藥的II期臨牀試驗。

該新藥是一種新型腫瘤免疫治療產品。2019年11月,復星醫藥產業就該新藥獲得MimiVax,LLC在區域內(即中國大陸、香港及澳門特別行政區)及領域內(即膠質母細胞瘤以及其他腫瘤和非腫瘤適應症的治療和預防)的獨家臨牀開發和商業化許可。

至公吿日,在全球範圍內尚未有與該新藥同靶點的藥品上市。截至2022年2月,集團現階段針對該新藥累計研發投入約為人民幣7364萬元(未經審計)。

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