Moderna向多国监管机构提交流感疫苗mRNA-1010上市申请

美股速递
Jan 05

生物技术公司Moderna宣布,其研发的mRNA流感疫苗mRNA-1010已正式向美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)、加拿大卫生部(Health Canada)以及澳大利亚治疗商品管理局(TGA)提交上市授权申请。这一关键进展标志着该疫苗在全球主要市场的监管审批程序全面启动。

此次多国同步申报的策略凸显了Moderna对拓展呼吸道疫苗市场的战略布局。若获批,mRNA-1010将成为该公司继新冠疫苗后又一重要商业化产品,有望为季节性流感预防提供创新解决方案。业界密切关注该疫苗在审批过程中的数据表现,其技术路径与传统灭活疫苗的差异化优势或成为监管考量的关键因素。

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