中慧生物CHO细胞新药临床试验获中美当局批准

格隆汇
Aug 17

中慧生物(2627.HK)公布,集团自主研发的重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂)的新药临床试验(IND)申请已经获得中国国家药品监督管理局药品审评中心(CDE)批准。此外,该款疫苗在美国的IND申请亦已获得美国食品及药物管理局(FDA)的批准。 呼吸道合胞病毒(RSV)作为一种高传染性RNA病毒,是导致婴儿、老年人和免疫功能不全者呼吸道感染的重要病原体之一。由于目前临床缺乏特效治疗药物,主要依靠支持性护理应对急性感染,疫苗接种成为RSV防控的优选临床解决方案。 集团的重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂)利用CHO细胞研制而成,可表达经修饰的pre-F蛋白。集团经广泛筛选获得了能够稳定表达pre-F蛋白的高产量单克隆细胞系。在临床前研究中,它表现出比已上市重组RSV疫苗更高的pre-F表达水平、更好的热稳定性和优异的免疫原性。

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