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復星醫藥(600196.SH):與BioNTech就新冠疫苗在區域內的合作在有序推進中
格隆匯 11-10 21:53

格隆匯 11 月 10日丨復星醫藥(600196.SH)公佈,之前公告披露,公司控股子公司上海復星醫藥產業發展有限公司(“復星醫藥產業”)於20203月獲BioNTech SE (“BioNTech”)授權在約定區域內獨家開發、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。

根據約定,此次合作所涉標的產品為BioNTech基於其mRNA技術平台研發的、針對新型冠狀病毒的疫苗產品(“新冠疫苗”)。截至目前,BioNTech已評估選擇開展臨牀試驗的4款候選新冠疫苗全部包括在此次合作範圍中。

合作區域:新冠疫苗在中國大陸及港澳台地區(即“區域內”)的開發和商業化由復星醫藥產業獲授權開展,區域外(即除中國大陸及港澳台地區以外的其他國家及地區)的開發和分銷則BioNTech和輝瑞合作實施。

合作進展:截至公告日,復星醫藥產業與BioNTech就新冠疫苗在區域內的合作推進中。BNT162b120207月獲國家藥品監督管理局(“國家藥監局”)臨牀試驗批准,並於中國境內(不包括港澳台地區,下同)處於I期臨牀試驗階段,截至目前已完成I期臨牀受試者接種程序,現處於數據統計分析過程中

截至公告日,其他候選新冠疫苗(包括BNT162b2)尚未於區域內進入臨牀試驗階段區域內新冠疫苗能否獲批上市,以及上市時間均存在不確定性

截至目前,全球範圍內尚無基於mRNA技術平台研發的預防性疫苗獲得上市批准。在研新冠疫苗在區域內能否獲得藥品監管機構(包括但不限於國家藥監局)批准、於區域內的上市時間存在不確定性

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