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复星医药(02196.HK)与BioNTech在中国开始新型肺炎疫苗临床试验
阿思达克 08-05 17:17
复星医药(02196.HK)和BioNTech(BNTX.US)宣布,在获得中国国家药品监督管理局临床试验批准後,截至目前,已有72名受试者接种BNT162b1疫苗。复星医药和BioNtech正在中国共同开发针对新冠病毒的mRNA疫苗产品,该试验是BioNTech全球开发计划的一部分。

集团指,在中国进行的临床I期试验计划招募144名健康受试者,以评估该候选疫苗的安全性和免疫原性,并确定剂量选择,受试者将在江苏省泰州一期临床基地受试。

是项研究将按照中国的监管审批程序进行,并进一步确认在德国和美国参与试验的受试者身上观察到的安全性和免疫原性状况与中国受试者相当。在德国和美国正在进行的临床研究将继续支持在中国的研究。

集团提到,和BioNTech计划持续探索及推进基於BioNTech专有mRNA技术的其他候选疫苗在中国进行临床试验的可能性。在临床开发阶段,BioNTech将通过其在欧洲的GMP认证的mRNA生产设施提供疫苗的临床供应。如果未来该疫苗获得销售许可,复星医药将在中国大陆及港澳台地区独家商业化基於BioNTech mRNA技术平台研发的针对COVID-19的疫苗产品。

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