次新追踪 | 荣昌生物-B盘中一度涨超12%,抗体药获美国临床试验许可
uSMART盈立智投11月16日消息,周一港股早盘,荣昌生物-B高开高走,截至11:39分,荣昌生物-B盘中一度涨超12%,触及75.7港元,股价创上市以来新高。
11月12日港股盘后,荣昌生物-B(09995.HK)宣布,公司自主研发的抗体药物偶联("ADC")新药注射用维迪西单抗(disitamabvedotin)(RC48)近日获得美国食品和药物管理局("FDA")针对晚期或转移性胃癌以及胃食管结合部腺癌的临床试验许可(IND),FDA还授予了维迪西单抗胃癌适应症快速审批通道认定("FTD")。
FDA的快速审批通道(FTD)专案旨在加速或促进用於治疗当前并无有效治疗方案的严重或危及生命的疾病或病情、且展示出有满足这一疾病当前未被满足的医疗需求潜力的新药的评审过程。有快速审批通道资格的候选药物可有资格与FDA进行更频繁的沟通、优先评审(如果符合相关标准)及新药申请(NDA)的滚动评审,加快相关药物的开发及上市进程。
此次维迪西单抗获美国FDA临床试验许可及快速审批通道认定为维迪西单抗在美国开展胃癌II期临床试验创造了条件。这是继该产品在2020年9月获得FDA授予治疗HER2表达二线尿路上皮癌治疗的突破性疗法之後的在国际市场的又一项重大进展。
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