復星醫藥(600196.SH):子公司新冠疫苗BNT162b2臨牀試驗申請獲受理
格隆匯11月12日丨復星醫藥(600196.SH)宣佈,2020年11月11日,公司控股子公司復星醫藥產業收到《受理通知書》,其獲許可的mRNA疫苗BNT162b2用於預防新型冠狀病毒肺炎獲國家藥監局臨牀試驗註冊審評受理。
復星醫藥產業於2020年3月獲德國BioNTech授權,在區域內(即中國大陸及港澳台地區)獨家開發、商業化基於其專有的mRNA技術平台研發的、針對新型冠狀病毒的疫苗產品,BioNTech為該疫苗在區域內的權利人。
BNT162b2系復星醫藥產業基於該次合作引進區域內的第二款針對新型冠狀病毒的mRNA疫苗,該疫苗為預防用生物製品,擬主要用於18-85歲人羣預防新型冠狀病毒肺炎。
目前,BNT162b2分別在美國、德國、阿根廷、巴西、南非和土耳其等國處於III期臨牀試驗中,並獲得美國FDA(即美國食品藥品管理局)快速通道審評認證。全球範圍內尚無基於mRNA技術平台研發的針對新型冠狀病毒的預防性疫苗獲得上市批准。
截至2020年10月,集團(即公司及控股子公司/單位)現階段針對此次mRNA疫苗許可及區域內研發的累計投入約為人民幣6619萬元(未經審計)。
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