赛诺菲(SNY.US)长效RSV单抗新适应症申报上市

智通财经08-07

智通财经APP获悉，8月7日，CDE官网公示，赛诺菲(SNY.US)尼塞韦单抗注射液一项新适应症上市申请获得受理，注册分类为3.1类。根据公开信息和临床试验进展，Insight数据库推测本次申报适应症为预防以下婴幼儿呼吸道合胞病毒(RSV)引起的下呼吸道感染：即将进入或在第二个RSV感染季期间出生的新生儿和婴儿。

截图来源：CDE官网

尼塞韦单抗是赛诺菲和阿斯利康联合开发的一种单剂量长效抗体疫苗，只需一剂，即可通过抗体提供快速保护，帮助预防由RSV引起的下呼吸道疾病，而无需激活免疫系统。

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