基石藥業(02616.HK)艾伏尼布新藥上市申請獲中國受理
基石藥業(02616.HK)公布,艾伏尼布(TIBSOVO,ivosidenib片劑)在中國的註冊研究CS3010-101研究達到預期終點,在攜帶易感異檸檬酸脫氫(酉每)-1(「IDH1」)突變的中國復發或難治性急性髓系白血病(「R/R AML」)患者中,艾伏尼布顯示了明確的療效和可控的安全性,且與之前發佈的全球研究人群中的療效和安全性數據基本一致。
同時公司宣布,中國國家藥品監督管理局已受理艾伏尼布的新藥上市申請(「NDA」),用於治療攜帶IDH1易感突變的成人R/RAML患者並擬納入優先評審。
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