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基石藥業-B(02616.HK)在2021年ESMO公佈艾伏尼布在攜帶易感IDH1突變的復發/難治性急性髓系白血病(R/RAML)患者的中國註冊橋接研究臨牀數據
格隆匯 09-21 08:04

格隆匯9月21日丨基石藥業-B(02616.HK)發佈公吿,基石藥業在2021年歐洲腫瘤內科學會(“ESMO”)年會上以優選口頭報吿形式(proffered paper presentation)公佈了同類首創藥物艾伏尼布中國註冊橋接研究CS3010-101的臨牀數據。

CS3010-101中國橋接研究是一項正在中國進行的I期、多中心、單臂研究。該研究旨在評估艾伏尼布口服治療攜帶易感IDH1突變的中國成人R/RAML患者的藥代動力學(“PK”)特徵、藥效動力學(“PD”)特徵、安全性和臨牀療效,並作為全球關鍵性研究AG120-C-001的橋接研究,提供中國R/RAML患者數據。

CS3010-101研究主要研究者、中國醫學科學院血液病醫院王建祥教授表示:“現有的針對IDH1突變的AML患者的治療手段有限,5年生存率較低,患者生活品質較差。艾伏尼布作為一款針對IDH1突變癌症的強效口服靶向抑制劑,我們很高興看到其中國橋接研究達到了預期的結果,展現了良好的療效與安全性,期待其能儘快造福中國的AML患者。”

基石藥業首席醫學官楊建新博士表示:“我們高興地看到艾伏尼布治療中國R/RAML患者的優異數據在ESMO年會上以優選口頭報吿的形式展示,這是國際學術界對於艾伏尼布的高度認可。我們會與NMPA密切協作,期待繼普吉華?和泰吉華?後早日把第三款同類首創新藥帶給中國患者。”

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