康辰药业(603590.SH):KC1036治疗晚期胸腺癌的关键性Ⅲ期临床研究获得CDE批准

智通财经
Mar 18

智通财经APP讯,康辰药业(603590.SH)发布公告,公司自主研发的KC1036片(简称“KC1036”)获得国家药品监督管理局药品审评中心(以下简称“CDE”)批准开展“评估KC1036对比研究者选择的化疗单药治疗既往至少一线含铂化疗失败的晚期复发或转移性胸腺癌的随机、开放、多中心Ⅲ期临床研究”。

KC1036是公司自主研发的化学药品1类创新药,公司拥有该产品的全球知识产权。KC1036通过抑制VEGFR2、AXL等多靶点实现抗肿瘤活性。KC1036具有较强的VEGFR血管靶向,抑制肿瘤细胞生长;通过抑制AXL,可以改善宿主的抗肿瘤免疫应答,从而避免肿瘤的免疫逃逸。

目前KC1036针对消化系统肿瘤、胸腺肿瘤、儿童尤文肉瘤等多个适应症正在开展临床研究,截至目前,已有超过350例受试者入组KC1036临床研究,现有临床研究结果显示了突出的抗肿瘤活性与安全性。

II期临床研究结果显示,KC1036在晚期复发或转移性胸腺癌中展现突出的抗肿瘤疗效且安全性可控。公司于近日获得CDE批准开展KC1036治疗晚期胸腺癌的关键性Ⅲ期临床研究,这是继三线治疗晚期食管鳞癌Ⅲ期临床研究之后,KC1036第2个获批开展关键性Ⅲ期临床研究的适应症。

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