港股异动 | 云顶新耀-B(01952)涨超9% 通用型肿瘤疫苗EVM14获批美国FDA临床试验

智通财经
24 Mar

智通财经APP获悉,云顶新耀-B(01952)涨超9%,截至发稿,涨8.7%,报68.1港元,成交额9991.85万港元。

消息面上,云顶新耀今早宣布,其通用型的现货肿瘤治疗性疫苗EVM14注射液的新药临床试验申请(IND)获美国食品药品监督监督管理局(FDA)的批准。EVM14不仅是云顶新耀首个获得FDA IND批准的自主研发新药和首款进入国际临床阶段的mRNA肿瘤治疗性疫苗,也是国产首款获得FDA IND批准的通用型的现货mRNA肿瘤疫苗。云顶新耀将于近期向中国国家药品监督管理局药品审评中心递交EVM14的临床试验申请。

云顶新耀基于自研mRNA技术平台开发的三款核心管线产品,即通用型的现货肿瘤治疗性疫苗 EVM14、已进入临床阶段的个性化肿瘤治疗性疫苗EVM16以及自体生成CAR-T产品,已成为公司在肿瘤及自身免疫疾病领域创新战略的三大核心支点,共同实现公司自研AI+mRNA技术平台的巨大价值。

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