10月20日，康宁杰瑞制药（09966）发布公告，JSKN003再次获得CDE突破性疗法认定，用于治疗既往经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的HER2+晚期CRC患者。
此前，JSKN003已于2025年3月获得CDE突破性疗法认定，用于治疗PROC，且不限HER2表达水平。中国CRC的发病率仅次于肺癌，每年新发病例数超过50万，患者群体面临巨大的未被满足的临床需求。
公告中提到，JSKN003在临床研究中显示出显著疗效和良好的安全性。在一项汇总分析中，HER2高表达CRC患者的客观缓解率（ORR）为61.9%，疾病控制率（DCR）为95.2%，中位无进展生存期（mPFS）为13.77个月。安全性方面，43例接受II期推荐剂量的患者中，仅6例（14%）发生3级及以上治疗相关不良事件（TRAEs）。JSKN003的开发与上海津曼特生物科技有限公司合作进行，预计将推动其在中国市场的商业化进程。
（文章来源：财中社）
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