云顶新耀(01952.HK)宣布中国台湾地区药政部门正式受理维长宁®(艾曲莫德)用于治疗中重度活动性溃疡性结肠炎的新药上市许可申请

智通财经
Aug 14
【云顶新耀(01952.HK)宣布中国台湾地区药政部门正式受理维长宁®(艾曲莫德)用于治疗中重度活动性溃疡性结肠炎的新药上市许可申请】智通财经APP获悉,云顶新耀(01952.HK)是一家专注于创新药研发、临床开发、制造和商业化的生物制药公司,近日宣布中国台湾地区药政主管部门(TFDA)已正式受理维长宁®(艾曲莫德,中国台湾地区商品名:维长宁®)用于治疗中重度活动性溃疡性结肠炎(UC)患者的新药上市许可申请(NDA)。此次受理标志着艾曲莫德继中国澳门、新加坡和中国香港获批和韩国NDA获正式受理之后,其在亚洲市场的准入取得重要进展。中国国家药品监督管理局也于2024年12月正式受理艾曲莫德(维适平®)的新药上市申请,预计今年年底或明年年初获批。

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