石藥集團(01093.HK):同類首創在研產品SYSA1801獲美國藥監局頒發孤兒藥資格認定
格隆匯 11 月 24日丨石藥集團(01093.HK)發佈公告,公司附屬公司石藥集團中奇製藥技術(石家莊)有限公司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)頒發針對治療胃癌(包括胃食管交界處癌)的孤兒藥資格認定。
胃癌在美國屬於罕見病,但在中國、日本及南韓等亞洲國家發病率很高。胃癌在中國各種惡性腫瘤中發病率居首位,但進展期胃癌患者的總體臨牀治療效果仍然很差。在北美,約三分之二的胃癌患者被診斷為局部晚期或轉移癌,半數以上的患者在初次治療後局部復發或遠處轉移,且該病在轉移後的五年中位生存率不到10%。目前胃癌的治療藥物和療法十分有限,主要採用常規化療和手術切除等,屬於未被滿足的臨牀需求。SYSA1801是一種抗Claudin-18.2全人源單克隆抗體-MMAE藥物偶聯物,臨牀前體外和體內的動物實驗顯示 SYSA1801能有效通過抗Claudin-18.2抗體靶向腫瘤細胞併發生內吞,將MMAE毒素帶入腫瘤細胞而起到治療胃癌和胰腺癌的作用。
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的臨牀開發、註冊及上市速度。集團計劃於2021年提交該在研藥物於中國及美國的臨牀試驗申請。
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