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榮昌生物-B(09995.HK):維迪西單抗獲美國臨牀試驗許可及快速審批通道認定
格隆匯 11-12 20:40

格隆匯11月12日丨榮昌生物-B(09995.HK)宣佈,公司自主研發的抗體藥物偶聯("ADC")新藥注射用維迪西單抗(disitamabvedotin)(RC48)近日獲得美國食品和藥物管理局("FDA")針對晚期或轉移性胃癌以及胃食管結合部腺癌的臨牀試驗許可(IND),FDA還授予了維迪西單抗胃癌適應症快速審批通道認定("FTD")。

FDA的快速審批通道(FTD)專案旨在加速或促進用於治療當前並無有效治療方案的嚴重或危及生命的疾病或病情、且展示出有滿足這一疾病當前未被滿足的醫療需求潛力的新藥的評審過程。有快速審批通道資格的候選藥物可有資格與FDA進行更頻繁的溝通、優先評審(如果符合相關標準)及新藥申請(NDA)的滾動評審,加快相關藥物的開發及上市進程。

此次維迪西單抗獲美國FDA臨牀試驗許可及快速審批通道認定為維迪西單抗在美國開展胃癌II期臨牀試驗創造了條件。這是繼該產品在2020年9月獲得FDA授予治療HER2表達二線尿路上皮癌治療的突破性療法之後的在國際市場的又一項重大進展。

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