石藥(01093.HK)附屬治療胰腺癌在研藥獲美國藥監局孤兒藥資格認定
石藥集團(01093.HK)公布,公司附屬石藥中奇製藥技術自主研發的抗體藥物偶聯物(ADC)SYSA1801獲得美國食品藥品監督管理局(FDA)頒發針對治療胰腺癌的孤兒藥資格認定。
集團指,SYSA1801是一種抗claudin-18.2全人源單克隆抗體-MMAE藥物偶聯物,臨床前體外和體內的動物實驗顯示SYSA1801能有效通過抗claudin-18.2抗體靶向腫瘤細胞並發生內吞,將MMAE毒素帶入腫瘤細胞而起到治療胰腺癌的作用。
該孤兒藥資格認定將使集團可與美國藥監局密切溝通,並加快SYSA1801的臨床開發、註冊及上市速度。
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