新诺威(300765.SZ):SYS6041(叶酸受体ADC)获得药物临床试验批准

智通财经
Jun 15

智通财经APP讯,新诺威(300765.SZ)发布公告,公司的控股子公司石药集团巨石生物制药有限公司(以下简称“巨石生物”)于近日收到国家药品监督管理局核准签发关于SYS6041(叶酸受体ADC)的《药物临床试验批准通知书》,将于近期开展临床试验。

SYS6041是一种靶向叶酸受体α(FRα)的抗体-药物偶联物。其FRα抗体部分与肿瘤细胞表面的FRα结合,通过内吞作用进入到肿瘤细胞后,经组织蛋白酶特异性剪切连接子,释放小分子毒素——拓扑异构酶Ⅰ抑制剂,从而杀伤肿瘤细胞,且可发挥旁观效应非特异性杀伤周围肿瘤组织细胞。SYS6041的潜在适应症为妇科肿瘤和肺癌等实体瘤。临床I期试验的现有数据显示,SYS6041在同类产品中具有竞争力。本次获批的SYS6041联合用药临床试验探索研究,将进一步拓展SYS6041的临床应用场景。

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