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复星医药(600196.SH):与BioNTech就新冠疫苗在区域内的合作在有序推进中
格隆汇 11-10 21:53

格隆汇 11 月 10日丨复星医药(600196.SH)公布,之前公告披露,公司控股子公司上海复星医药产业发展有限公司(“复星医药产业”)于20203月获BioNTech SE (“BioNTech”)授权在约定区域内独家开发、商业化基于其专有的mRNA技术平台研发的、针对新型冠状病毒的疫苗产品。

根据约定,此次合作所涉标的产品为BioNTech基于其mRNA技术平台研发的、针对新型冠状病毒的疫苗产品(“新冠疫苗”)。截至目前,BioNTech已评估选择开展临床试验的4款候选新冠疫苗全部包括在此次合作范围中。

合作区域:新冠疫苗在中国大陆及港澳台地区(即“区域内”)的开发和商业化由复星医药产业获授权开展,区域外(即除中国大陆及港澳台地区以外的其他国家及地区)的开发和分销则BioNTech和辉瑞合作实施。

合作进展:截至公告日,复星医药产业与BioNTech就新冠疫苗在区域内的合作推进中。BNT162b120207月获国家药品监督管理局(“国家药监局”)临床试验批准,并于中国境内(不包括港澳台地区,下同)处于I期临床试验阶段,截至目前已完成I期临床受试者接种程序,现处于数据统计分析过程中

截至公告日,其他候选新冠疫苗(包括BNT162b2)尚未于区域内进入临床试验阶段区域内新冠疫苗能否获批上市,以及上市时间均存在不确定性

截至目前,全球范围内尚无基于mRNA技术平台研发的预防性疫苗获得上市批准。在研新冠疫苗在区域内能否获得药品监管机构(包括但不限于国家药监局)批准、于区域内的上市时间存在不确定性

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