港股异动 | 云顶新耀(01952)早盘涨超5% 维适平®由境外转移至境内生产的药品上市注册申请获受理

智通财经
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智通财经APP获悉,云顶新耀(01952)早盘涨超5%,截至发稿,涨3.49%,报27.24港元,成交额2702万港元。

消息面上,9月17日,据云顶新耀官微消息,公司宣布中国国家药品监督管理局(NMPA)药品审评中心(CDE)已受理维适平®(精氨酸艾曲莫德片,VELSIPITY®)由境外转移至境内生产的药品上市注册申请,并纳入优先审评审批程序。维适平®本地化生产有望于2027年正式投产,将进一步提升其在中国及亚太市场的供应能力,增强供应保障。此次获受理是维适平®商业化战略按计划推进的重要进展。

据介绍,2026年3月维适平®开出首张处方,正式进入中国临床应用阶段。在快速实现商业化落地的同时,维适平®积极参与国家医保目录谈判。在云顶新耀授权区域内,维适平®已在中国大陆、中国香港、中国澳门、新加坡及韩国获得新药上市批准,并有望于2026年下半年在中国台湾获批上市。

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