港股异动 | 中慧生物-B(02627)涨超7% 重组呼吸道合胞病毒疫苗IND申请中美双报获批

智通财经
Aug 18

智通财经APP获悉,中慧生物-B(02627)涨超7%,截至发稿,涨7.25%,报50.6港元,成交额1364.46万港元。

消息面上,中慧生物公告,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药品监督管理局(FDA)的批准。

公告指出,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。在集团的临床前研究中,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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