康方生物(09926.HK)旗下新药获准纳入突破性治疗药物品种
康方生物(09926.HK)公布,公司核心自主研发的、全球首创的新型肿瘤免疫治疗双特异性抗体新药PD-1/CTLA-4(研发代号:AK104)用於治疗复发或转移性宫颈鳞癌,获得中国国家药品监督管理局药品审评中心(CDE)审核同意,纳入「突破性治疗药物品种」,并在其官网公示。
对纳入突破性治疗药物程序的药物,CDE将优先配置资源进行沟通交流,并加强指导并促进药物研发。另外,经评估符合相关条件的药物,也可以在申请药品上市许可时,提出附条件批准申请和优先审评审批申请。公司相信相关程序将有助於AK104加速药物研发和产品上市。
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