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和譽-B(02256.HK):泛FGFR抑制劑ABSK091(AZD4547)針對尿路上皮癌臨牀二期試驗完成首例患者給藥
格隆匯 12-02 07:39

格隆匯12月2日丨和譽-B(02256.HK)發佈公吿,2021年12月2日,和譽醫藥宣佈其在研的泛FGFR抑制劑ABSK091(AZD4547)治療尿路上皮癌的臨牀二期試驗完成首例受試者給藥。

根據披露,本次完成首例患者入組的臨牀試驗(ABSK091-201,NCT05086666),是一項在中國開展的二期、多中心、單臂、開放性的臨牀試驗,旨在評估ABSK091 (AZD4547)治療存在FGFR2/3基因改變(包括突變和╱或融合)的局部晚期或轉移性尿路上皮癌患者的有效性及安全性。

該研究的主要研究者、復旦大學附屬腫瘤醫院葉定偉教授表示:“尿路上皮癌是泌尿系統常見的惡性腫瘤,其中20-30%的患者伴有FGFR基因異常,目前在中國針對這部份病人缺乏有效的治療手段,仍有大量未滿足的臨牀需求。因此我很期待這一新療法的臨牀試驗,為患者帶來更好的治療選擇。”

和譽醫藥首席醫學官嵇靖博士表示:“ABSK091(AZD4547)是全球範圍內最早開發的泛FGFR抑制劑之一。二期臨牀第一例患者的入組,是我們在這個公司核心產品上取得的又一個重要里程碑事件。我們將和研究者一起,全力推進臨牀研究進程,爭取為患者提供更多更好的治療選擇。”

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