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　　康宁杰瑞制药-B（09966）发布公告，JSKN033（HER2双特异性抗体偶联药物（ADC）与PD-L1免疫检查点抑制剂的高浓度皮下注射复方制剂）的一项 I/II期临床试验（研究编号：JSKN033-102）已获得国家药品监督管理局（国家药监局）药品审评中心（CDE）新药临床试验申请（IND）批准。

　　JSKN033-102是一项开放、多中心、I/II期临床试验，旨在评估JSKN033在晚期转移性恶性肿瘤患者中的安全性、耐受性、药代动力学/药效学及抗肿瘤活性，并确定最大耐受剂量及/或推荐II期剂量。

　　在澳大利亚进行的首次人体I/II期临床研究（JSKN033-101）表明JSKN033安全性良好，在多线治疗后疾病进展的患者中具有令人鼓舞的抗肿瘤活性，详细的临床研究数据已在2024年癌症免疫治疗学会年会上公布，并可参考本公司2024年11月10 日的自愿性公告。

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