葛兰素史克:RSV疫苗Arexvy在华注册申请获受理预计2027年获批

格隆汇
Feb 10

葛兰素史克2月10日宣布,其重组呼吸道合胞病毒(RSV)疫苗Arexvy的注册申请已获中国国家药品监督管理局药品审评中心受理,预计将于2027年获批。葛兰素史克此前于上月底披露,其RSV疫苗在中国针对60岁及以上成人进行的免疫原性和安全性评估的三期试验(NCT06551181)中取得积极的主要结果。所有主要终点均已达成,疫苗耐受性良好,安全性数据符合预期。葛兰素史克表示,如果获批,预计其RSV疫苗将成为中国国家药品监督管理局批准的首款用于60岁及以上成人预防由RSV引发的下呼吸道疾病(LRTD)的疫苗。

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