智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，JSKN003获得国家药品监督管理局药品审评中心突破性疗法认定，用于治疗铂耐药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌，且不限人表皮生长因子受体2 表达水平。
此次获突破性疗法认定，是基于JSKN003-101及JSKN003-102两项临床研究的汇总分析结果。JSKN003-101为一项于澳大利亚晚期╱转移性实体瘤患者中开展的首次人体、开放性标签和多中心的I期临床研究，分为剂量递增阶段和剂量扩展阶段。JSKN003-102为一项于中国晚期实体瘤患者中开展的I期(剂量递增及剂量扩展)及II期(队列扩展)临床研究。JSKN003在该适应症的III期临床研究正处于入组阶段，目前正在顺利进行中。
JSKN003作为新型双特异性抗体偶联药物，利用酶催化和点击化学反应的协同作用机制，提高血清稳定性和旁观者杀伤效应的同时，展现出更加优异的疗效。此次获得突破性疗法认定，有望加快JSKN003的临床开发和审评审批速度，早日使更多PROC患者获益。
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