復星醫藥:子公司新冠疫苗臨牀試驗收到中國的受理通知書
uSMART盈立智投11月12日消息,週四港股盤前,復星醫藥發佈《關於控股子公司獲藥品臨牀試驗申請受理的公告》。
2020 年 11 月 11 日,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(以下簡稱“該疫苗”)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 SE(以下簡稱“BioNTech”)授權,在區域內(即中國大陸及港澳臺地區,下同)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 爲該疫苗在區域內的權利人(以下簡稱“本次合作”)。
BNT162b2 是復星醫藥產業基於本次合作引進區域內的第二款針對新型冠狀病毒的 mRNA 疫苗,該疫苗爲預防用生物製品,擬主要用於 18-85 歲人群預防新型冠狀病毒肺炎。截至本公告日,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。截至本公告日,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,本集團(即本公司及控股子公司/單位)現階段針對本次mRNA 疫苗許可及區域內研發的累計投入約爲人民幣 6,619 萬元(未經審計)。
點擊可跳轉閱讀《復星醫藥關於控股子公司獲藥品臨牀試驗申請受理的公告》原文件PDF。
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