艾美疫苗获FDA批准开展mRNA疫苗临床试验

财中社
27 Feb

  2月27日,艾美疫苗(06660)发布公告,宣布其mRNA呼吸道合胞病毒疫苗已获得美国食品和药品监督管理局(FDA)批准开展临床试验。这是公司首次获得FDA批准进行临床试验,标志着其国际化战略的重要进展。公告中提到,该疫苗在临床前动物试验中,特异性IgG抗体滴度、真病毒中和抗体效价以及特异性T细胞免疫均显著高于国际上市的对照疫苗,显示出其研发成果的竞争力。

  呼吸道合胞病毒是导致婴儿和老年人呼吸道感染的重要病原体,目前全球尚无针对该病毒的获批抗病毒特效药,因此接种疫苗成为预防重症感染的有效手段。公司作为中国最早开发mRNA疫苗的企业之一,已建立成熟的研发体系和符合GMP标准的生产车间,能够快速实现疫苗的产业化。随着该疫苗的上市,公司有望迎来新的业绩增长点。

(文章来源:财中社)

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