智通财经APP讯，康希诺生物(06185)发布公告，公司为其吸附无细胞百(五组分)白破联合疫苗(6岁及以上人群用)(青少年及成人用Td5cp)的新药上市申请(NDA)获得中国国家药品监督管理局药品审评中心纳入优先审评。根据国家优先审评审批的规定，国家药监局药品审评中心对纳入优先审评审批的NDA，将优先配置资源进行审评。
青少年及成人用Td5cp适用于6岁及以上人群，为青少年及成人的百白破加强疫苗。尽管主要发达国家已将该疫苗纳入常规的疫苗接种计划，但目前国内并无获批的青少年及成人用百白破加强疫苗。因此，该产品若成功上市，将解决国内市场现有空白。公司的婴幼儿用吸附无细胞百(三组分)白破联合疫苗(2岁以下)(婴幼儿用DT3cP)已于2026年4月获得NDA批准。青少年及成人用Td5cp较婴幼儿用DT3cP增加另外两种百日咳抗塬组分，为一款五组分百白破疫苗，每种百日咳抗塬可以单独纯化，以确定的比例配制，从而可以确保产品质量批间一致性，使产品的质量更加稳定。
公司正在准备青少年及成人用Td5cp的NDA递交工作
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