港股异动 | 再鼎医药(09688)逆市涨超7% 近日Zoci获欧洲药品管理局孤儿药资格认定

智通财经
Jun 18

智通财经APP获悉,再鼎医药(09688)逆市涨超7%,截至发稿,涨6.27%,报14.4港元,成交额7254.49万港元。

消息面上,近日,据再鼎医药官微消息,公司宣布,欧洲药品管理局已授予具有同类首创潜力的靶向Delta样配体3(DLL3)的抗体药物偶联物(ADC)zocilurtatug pelitecan(zoci,前称ZL-1310)孤儿药资格认定,用于治疗来源于肺的神经内分泌癌。此前,美国FDA已授予zoci用于治疗小细胞肺癌的快速通道资格认定(FTD)及孤儿药资格认定。FDA近期还授予了zoci用于治疗肺外神经内分泌癌的FTD。

Zoci是一款靶向DLL3的新型ADC。DLL3是一种经过验证的治疗靶点,在包括小细胞肺癌(SCLC)和肺外神经内分泌癌(epNECs)在内的多种神经内分泌肿瘤中过度表达,通常与不良临床预后相关。Zoci有望成为再鼎医药首个全球上市的抗肿瘤产品,计划到2026年底开展三项注册性研究,涉及二线及以上SCLC、一线SCLC以及肺外神经内分泌癌。

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