2026年8月16日，康希诺生物股份公司（06185）公告称，其自主开发的吸附无细胞百（五组分）白破联合疫苗（6岁及以上人群用）（简称“青少年及成人用Td5cp”）的新药上市申请（NDA）已获国家药品监督管理局出具的受理通知书。
青少年及成人用Td5cp用于6岁及以上人群，可作为百白破加强免疫接种。目前国内尚无获批的青少年及成人用百白破加强疫苗，该产品若成功上市将填补市场空白。
与公司已于2026年4月获得NDA批准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”）相比，青少年及成人用Td5cp新增两种百日咳抗原组分，为五组分百白破疫苗。公告称，该设计可使各抗原独立纯化并按确定比例配制，提升批间一致性和产品质量稳定性。
此外，青少年及成人用Td5cp已被国家药品监督管理局药品审评中心纳入优先审评程序。
公司提醒投资者在买卖公司股份时保持审慎。
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