中国生物制药:IDH1抑制剂TQB3454胆道癌III期临床达优效终点

南方财经网
Mar 12

  南财智讯3月12日电,中国生物制药(01177.HK)发布自愿公告,公告基本信息:公司附属正大天晴自主研发的国家1类创新药TQB3454(IDH1抑制剂)治疗伴IDH1突变晚期胆道癌的III期临床研究(NCT05987358)完成预设期中分析,独立数据监查委员会(IDMC)确认主要终点无进展生存期(PFS)和总生存期(OS)均达到方案预设优效界值;主要内容:该研究为随机、双盲、安慰剂对照、多中心III期试验,入组既往含吉西他滨和氟尿嘧啶类联合方案治疗失败的伴IDH1突变晚期胆道癌患者,结果显示TQB3454显著降低疾病进展或死亡风险,延长PFS与OS,安全性良好、未见新风险信号;背景与说明:胆道癌全球年新发超20万例,5年生存率不足5%,高度侵袭且缺乏有效靶向治疗,目前国内尚无IDH1抑制剂获批,临床需求迫切;TQB3454已于2023年4月被国家药监局药品审评中心(CDE)纳入突破性治疗药物程序;影响与展望:公司已获CDE书面同意递交上市申请,预计近期提交,该成果系全球第2个、国内首个IDH1抑制剂在胆道癌领域达成阳性III期结果,有望加速上市并填补国内治疗空白,提升公司在肿瘤精准治疗领域的竞争力。

(文章来源:南方财经网)

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