信达生物(01801.HK)旗下产品治疗晚期胆管癌患者完成中国首例给药
信达生物(01801.HK)公布,公司成纤维细胞生长因数受体1/2/3抑制剂pemigatinib(IBI-375)的2期关键性注册临床研究完成中国首例患者给药。该研究的目的是评估pemigatinib在既往至少接受过一线系统治疗、成纤维细胞生长因数受体2(FGFR2)基因融合或重排的中国晚期胆管癌患者中的有效性和安全性。研究结果将用於pemigatinib在中国的新药上市申请。Pemigatinib是一种针对FGFR亚型1/2/3的强效选择性口服抑制剂,在临床前研究中已证实该药物对FGFR基因突变的肿瘤细胞具有选择性的药理学活性。
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