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信達生物(01801.HK):IBI-306(抗PCSK-9單抗)治療中國雜合子型家族性高膽固醇血癥III期臨牀研究達到主要研究終點
格隆匯 08-12 07:35

格隆匯8月12日丨信達生物(01801.HK)發佈公吿,由公司自主研發的重組全人源抗前蛋白轉化酶枯草溶菌素9(“PCSK-9”)單克隆抗體注射液(研發代號:IBI-306)治療中國雜合子型家族性高膽固醇血癥(“HeFH”)III期臨牀研究(研究代號為CREDIT-2)達到主要研究終點。

分析顯示,在接受他汀和╱或依折麥布治療的中國雜合子型家族性高膽固醇血癥患者中使用IBI-306連續治療12周後,與安慰劑相比,低密度脂蛋白膽固醇(“LDL-C”)水準獲得顯著改善。整個研究期間,IBI-306總體安全性良好,與其他已上市PCSK-9抑制劑已報導的安全性特徵相似。

根據披露,中國家族性高膽固醇血癥患者人數位居全球前列,其中雜合子患者發病年齡早,血清總膽固醇(“TC”)及LDL-C水準升高顯著,病情進展迅速危害大,患者在青中年就可出現嚴重動脈粥樣硬化性心血管疾病(“ASCVD”)甚至死亡。PCSK-9抑制劑是近年來針對此疾病的有效治療,已經被美國,歐盟及國內指南推薦在家族性高膽固醇血癥患者中應用,但目前中國HeFH人羣中應用的高等級臨牀證據依然空白。

公司欣喜地看到,作為中國獨立自主智慧財產權的創新型抗PCSK-9單克隆抗體IBI-306的關鍵註冊研究之一的CREDIT-2達到主要研究終點。這是中國研究者首次利用隨機、雙盲及對照的研究方法證實了抗PCSK-9單克隆抗體在中國HeFH患者中可顯著降低LDL-C水準且總體安全性良好。此研究為中國HeFH人羣提供了新的高品質的臨牀證據。

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