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亞盛醫藥-B(06855.HK)APG-1387聯合化療治療晚期胰腺癌的Ib/II期臨牀試驗在中國獲批
格隆匯 02-24 17:06

格隆匯2月24日丨亞盛醫藥-B(06855.HK)公告,公司在研原創1類新藥APG-1387日前獲得國家藥品監督管理局(NMPA)藥物審評中心(CDE)批准,將在中國開展其聯合化療在晚期胰腺癌患者中的Ib/II期臨牀研究。

APG-1387為新一代凋亡蛋白抑制因子(IAP)高效特異性抑制劑,也是中國首個進入臨牀階段的IAP抑制劑。此次獲批的研究是一項多中心、開放性的Ib期劑量探索研究以及II期療效探索研究,旨在評價APG-1387聯合白蛋白紫杉醇及吉西他濱治療晚期胰腺癌的安全性、PK特徵及初步的療效。

據悉,APG-1387已在中國和澳大利亞完成針對晚期實體瘤的I期研究,臨牀顯示耐受性良好。同時,該產品在美國進行的I期臨牀研究初期數據以壁報形式發表於2019年美國臨牀腫瘤學會(ASCO)年會。該研究發現,APG-1387單藥對於既往多線治療失敗的晚期胰腺癌患者,顯示出一定的抗腫瘤活性,10例單藥治療的晚期胰腺癌患者中,有4例獲得疾病穩定(SD),其中1例SD超過9個治療週期。

胰腺癌是一種惡性程度很高的消化系統腫瘤。由於預後較差,其發病率約等於死亡率。2015年統計數據顯示中國胰腺癌患者的5年生存率為7.2%,是中國生存率最低的腫瘤。目前胰腺癌的治療方案及藥物選擇仍非常有限。公司將盡快推進APG-1387的臨牀試驗,爭取為罹患該疾病的患者提供新的治療選擇。

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