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和譽-B(02256.HK):CDE批准開展依帕戈替尼(ABSK011)用於HCC患者的註冊性臨牀研究
格隆匯 12-16 17:33

格隆匯12月16日丨和譽-B(02256.HK)發佈公吿,公司的附屬公司上海和譽生物醫藥科技有限公司(“和譽醫藥”)今日宣佈其自主研發的高選擇性小分子FGFR4抑制劑依帕戈替尼(ABSK011)註冊性臨牀研究獲中國國家藥品監督管理局藥品審評中心(“CDE”)的批准。這項研究將作為支持依帕戈替尼潛在批准上市的關鍵依據,標誌着依帕戈替尼在晚期或不可切除肝細胞癌(“HCC”)治療領域達成了重要的里程碑。

此次獲批的註冊性臨牀研究(ABSK-011-205)是一項多中心、隨機、雙盲的研究,旨在評估依帕戈替尼聯合最佳支持性治療(“BSC”)與安慰劑聯合BSC在經免疫治療和多靶點酪氨酸激酶抑制劑(“mTKI”)治療的FGF19過表達的晚期或不可切除的肝細胞癌患者治療中的有效性和安全性。

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