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石藥集團(01093.HK):抗體藥物偶聯物"SYSA1801"獲美國臨牀試驗批准
格隆匯 07-16 16:41

格隆匯7月16日丨石藥集團(01093.HK)宣佈,集團研發的抗體藥物偶聯物(Antibody-Drug Conjugate)"SYSA1801"的試驗性新藥(IND)申請已獲美國食品藥品監督管理局(FDA)批准,可開展Claudin 18.2陽性表達的晚期胰腺癌的臨牀試驗。此I期臨牀試驗將會評估SYSA1801的安全性、耐受性、藥代動力學特性及初步療效。

SYSA1801是一種創新(同類首創)的抗Claudin 18.2單克隆抗體藥物偶聯物。臨牀前體外和體內的動物試驗顯示該產品能有效通過抗Claudin 18.2抗體靶向腫瘤細胞併發生內吞,將小分子毒素帶入腫瘤細胞而起到抗腫瘤作用。臨牀前研究顯示,該產品對胰腺癌具有優異的體內外活性和良好的安全性,極有希望在臨牀試驗中展現出良好治療效果。

該產品已於2021年獲美國FDA頒發針對治療胰腺癌的孤兒藥資格認定。集團將全力推進該產品的臨牀試驗,力爭該產品儘快上市。

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