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▎药明康德内容团队报道

今日(4月16日),中国国家药监局药品审评中心(CDE)官网最新公示,康弘药业全资子公司康弘生物申报的1类新药注射用KH815获批临床,拟开发治疗晚期实体瘤。公开资料显示,这是康弘生物研发的一种具有抗耐药潜力的靶向滋养层细胞表面抗原2(TROP2)的新型双载荷(dual-payload)抗体偶联药物(ADC)。该产品于今年3月在澳大利亚获批1期临床研究。本次是该产品首次在中国获批临床。

截图来源:CDE官网

TROP2是一种广泛表达的糖蛋白抗原,可促进肿瘤细胞增殖、侵袭、转移扩散等过程,其高表达与肿瘤患者生存期缩短及不良预后密切相关。

公开资料显示,KH815由人源化的IgG1抗体(hRS7)组成,该抗体直接针对TROP2,结合拓扑异构酶I抑制剂(TOP1i)和RNA聚合酶II抑制剂(RNAPOLIIi)。KH815的双载荷使其能够同时抑制RNA合成和诱导DNA双链断裂,具有双效协同机制。此外其还能降低P-gp和HSP70蛋白的表达,克服耐药,增加细胞对化疗药物的敏感性。

根据美国癌症研究协会(AACR)年会官网公布的临床前研究结果,体外药效研究显示,KH815对TROP2不同表达水平的肿瘤细胞均具有纳摩尔级别的杀伤活性。体内药效研究显示,KH815在多个瘤种的CDX模型和PDX型中均表现出剂量依赖的抑制肿瘤生长作用,并且在多个喜树碱类ADC耐药的CDX和PDX模型中也显示出抗肿瘤作用。双载荷设计有望使KH815具有较高的人体抗肿瘤应答率,且对单喜树碱类ADC耐药患者具有治疗潜力。

参考资料:

[1] 中国国家药监局药品审评中心(CDE)官网. RetrievedApr16,2025,Fromhttps://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]1586/2-KH815,anoveldual-payloadTROP2-directedantibody-drugconjugate,showspotentantitumorefficacyinpre-clinicaltumormodel.Retrieved Apr28,2025,from https://www.abstractsonline.com/pp8/#!/20273/presentation/7136

[3]康弘药业关于子公司收到澳大利亚HREC批准的公告. RetrievedMar27,2025,From http://www.cninfo.com.cn/new/disclosure/detail?plate=szse&orgId=9900022951&stockCode=002773&announcementId=1222911145&announcementTime=2025-03-27

免责声明:药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的,文中观点不代表药明康德立场,亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导,请前往正规医院就诊。

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