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信達生物-B(01801.HK)PEMIGATINIB治療晚期膽管癌患者完成中國首例給藥
格隆匯 03-04 07:37

格隆匯3月4日丨信達生物-B(01801.HK)公佈,公司成纖維細胞生長因數受體1/2/3抑制劑pemigatinib(IBI-375)的2期關鍵性註冊臨牀研究完成中國首例患者給藥。本研究的目的是評估pemigatinib在既往至少接受過一線系統治療、成纖維細胞生長因數受體2(FGFR2)基因融合或重排的中國晚期膽管癌患者中的有效性和安全性。本研究結果將用於pemigatinib在中國的新藥上市申請。

膽管癌缺乏有效的治療手段,預後性差,存在很大未被滿足的醫學需求。本研究取得的進展是pemigatinib進入中國市場重要的里程碑事件。基於前期臨牀研究所展現出的顯着療效和安全性資料,公司相信,本研究在中國臨牀試驗的開展將會使更多膽管癌患者獲益,為臨牀醫生帶來更多治療選擇。

Pemigatinib是一種針對FGFR亞型1/2/3的強效選擇性口服抑制劑,在臨牀前研究中已證實該藥物對FGFR基因突變的腫瘤細胞具有選擇性的藥理學活性。此前,pemigatinib已獲得FDA突破性療法認定,用於治療既往經治的晚期╱轉移性或不可切除的FGFR2基因易位型膽管癌。此外,FDA還授予pemigatinib孤兒藥認定,用於治療膽管癌。這類認定一般授予計劃用於安全有效地治療、診斷或預防影響20萬人以下的罕見疾病的研究化合物。

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