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亞盛醫藥(06855.HK)治療黑色素瘤藥物獲美國授予快速通道資格
阿思達克 09-23 09:07
亞盛醫藥(06855.HK)公布,其在研原創新藥MDM2-p53抑制劑alrizomadlin(APG-115)獲得美國食品和藥品監督管理局(FDA)授予的快速通道資格(FTD),用於經腫瘤免疫治療後的復發/難治性不可切除/轉移性黑色素瘤患者。 此前,APG-115已獲得FDA授予的5項孤兒藥資格認證(ODD),其中一項適應症為IIB-IV期黑色素瘤。 APG-115是亞盛醫藥自主的一種口服、高選擇性的小分子MDM2抑制劑,對MDM2具有高度結合親和力,通過阻斷MDM2-p53相互作用從而恢復p53腫瘤抑制活性。
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