智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，公司自主研发的靶向表皮生长因子受体(EGFR)╱人表皮生长因子受体3(HER3)的双抗双载荷偶联药物(ADC(s))JSKN021新药临床试验(IND)申请，已获国家药监局药品审评中心(CDE)正式受理。
公司计划开展JSKN021用于治疗晚期恶性实体瘤的I期临床研究，旨在评估其在该等患者人群中的安全性、耐受性、药代动力学及抗肿瘤活性，并确定最大耐受剂量及╱或推荐II期剂量。
于2025年美国癌症研究协会年会发布的临床前数据显示，JSKN021能有效抑制 ER3阳性、EGFR阳性或双阳性肿瘤细胞的生长。此外，在多种CDX模型中， JSKN021的肿瘤抑制效果显著优于单载荷ADC药物。
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