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亞盛醫藥-B(06855.HK)在研晚期胰腺癌新藥獲批展開Ib/II期臨床研究
阿思達克 02-24 17:06
亞盛醫藥-B(06855.HK)公布,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期臨床研究。 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床階段的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。
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