金吾财讯 | 再鼎医药(ZLAB)周一宣布，其自研靶向DLL3的抗体偶联药物(ADC)Zoci(zocilurtatugpelitecan，原ZL-1310)获美国FDA授予快速通道资格，用于治疗经一线标准治疗后进展的肺外神经内分泌癌(epNECs)。据悉，epNECs为侵袭性强、预后差的恶性肿瘤，全球约10万人患病，无获批靶向疗法与标准治疗方案，存在巨大未满足医疗需求。此前2025年5月，Zoci已获FDA快速通道资格，用于广泛期小细胞肺癌(ES-SCLC)治疗。此外，2026年AACR年会公布的Ib/II期注册研究显示，Zoci用于多线治疗失败的epNEC患者，客观缓解率(ORR)达38.2%，且安全性可控，仅中性粒细胞减少为唯一≥3级且多例出现的治疗相关不良反应。目前Zoci的epNEC临床项目正推进注册，已与药监部门沟通注册计划。截至发稿，再鼎医药美股股价盘前上扬4.84%，最新报19.50美元。
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