港股异动 | 君实生物(01877)涨超5% 抗PD-1单抗联合疗法纳入CDE突破性治疗品种名单

智通财经
10 Feb

智通财经APP获悉,君实生物(01877)涨超5%,截至发稿,涨5.37%,报12.16港元,成交额1805.43万港元。

消息面上,君实生物近日宣布,由公司自主研发的抗PD-1单抗药物特瑞普利单抗(商品名:拓益®)联合迈威生物自主研发的靶向Nectin-4抗体偶联药物(ADC)创新药(研发代号:9MW2821)近日被国家药品监督管理局(NMPA)药品审评中心(CDE)纳入突破性治疗品种名单。本次纳入的适应症为特瑞普利单抗联合9MW2821用于治疗既往未经系统治疗的、不可手术切除的局部晚期或转移性尿路上皮癌。

此外,2月5日晚,君实生物公布,公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,AWT020注射用无菌粉末(项目代号“JS213”)的临床试验申请获得批准。据悉,JS213是PD-1和白细胞介素-2(IL-2)双功能性抗体融合蛋白,主要用于晚期恶性肿瘤的治疗。临床前研究表明,JS213在多个动物模型中显示出了显著的抑瘤作用。此外,JS213具有良好、可接受的安全性和耐受性。

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