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石藥集團(01093.HK):抗體藥物偶聯物“SYSA1801”獲中國臨牀試驗批准
格隆匯 06-16 18:11

格隆匯6月16日丨石藥集團(01093.HK)發佈公吿,集團開發的抗體藥物偶聯物(Antibody-Drug Conjugate) “SYSA1801”已獲得中國國家藥品監督管理局批准,可開展於中國的臨牀研究。該產品在國內外已提交多件專利申請。

根據披露,SYSA1801是一個抗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其能有效通過抗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治療腫瘤作用。本次獲批臨牀試驗的適應症為Claudin 18.2表達實體瘤。臨牀前試驗顯示,SYSA1801對胃癌、胰腺癌以及肺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的治療效果。中國是胃癌和肺癌高發國家,胰腺癌的病死率也呈上升趨勢,對新治療靶點和新藥物具有巨大需求。集團將全力以赴推進該產品的臨牀研究工作,力爭該產品儘快上市。 

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