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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 05-07 16:34

格隆匯 5 月 7日丨石藥集團(01093.HK)宣佈,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)頒發針對治療胰腺癌的孤兒藥資格認定。

胰腺癌導致每年全球超過43萬人死亡,是惡性程度最高的腫瘤之一。美國癌症協會2019年統計資料顯示,其1年整體生存率僅約24%,5年整體生存率約9%,佔美國腫瘤相關死亡的第4位。胰腺癌的診斷和治療方法十分有限,90%的患者被診斷時已是局部晚期或轉移癌,轉移後的五年中位生存率不到6%,而目前胰腺癌的治療方法侷限於常規化療和手術切除,屬於高度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。

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