翰森制药(03692):HS-20093治疗骨肉瘤III期临床研究达到主要终点

智通财经
Jul 28

智通财经APP讯,翰森制药(03692)公布,该集团自研B7-H3靶向抗体-药物偶联物(ADC)HS-20093,在用于既往接受过至少二线系统治疗后进展或复发的骨肉瘤患者的关键性III期临床试验(ARTEMIS-011)中达到主要终点。与化疗相比,HS-20093在独立评审委员会 (IRC)评估的无进展生存期(PFS)方面,显示出具有统计学显著性和临床意义的改善,包括总生存期(OS)和研究者评估PFS在内的次要临床终点亦观察到一致的获益。安全性特征与既往研究结果一致,未发现新的安全性信号。

基于以上积极结果,集团将于近期启动与相关监管机构的沟通,开展推进在中国的新药上市申请准备工作。ARTEMIS-011研究详细数据预计未来在国际肿瘤学术大会上予以公布。

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