中慧生物-B(02627):中国药审中心批准MRNA RSV疫苗IND申请

智通财经
May 08

智通财经APP讯,中慧生物-B(02627)发布公告,继集团于2025年11月7日获美利坚合众国食品药品监督管理局批准其于美国提交的新药临床试验申请后,国家药品监督管理局药品审评中心已批准集团自主研发的mRNA RSV疫苗候选产品的IND申请。

RSV是一种导致呼吸道感染的常见病毒,尤其是在老年人和慢性病患者等易感染人群中,可能发展成细支气管炎或肺炎等严重病例。目前在中国,RSV感染的治疗仍依赖广谱抗病毒药物及对症治疗。因此,迫切需要开发一种有效的RSV疫苗。mRNA疫苗已在临床研究中显示出诱导强烈的细胞免疫反应及持久的体液免疫,使其成为保护老年人及免疫功能低下人群免受RSV引起的严重下呼吸道感染的一项具前景选择。

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