智通财经APP讯，君实生物(688180.SH)公告，近日，公司收到国家药品监督管理局(简称“国家药监局”)核准签发的《药品补充申请批准通知书》，特瑞普利单抗(商品名：拓益®，产品代号：JS001)用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗的适应症获得国家药监局同意，由附条件批准转为常规批准。
附条件批准上市审评审批政策旨在鼓励以临床价值为导向的药物创新，加快具有突出临床价值的临床急需药品上市。2018年12月17日，基于一项多中心、单臂、开放标签的II期临床研究(POLARIS-01研究，NCT03013101)，特瑞普利单抗获得国家药监局附条件上市批准，用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗，成为我国批准上市的首个国产以PD-1为靶点的单抗药物。此次获得常规批准，意味着特瑞普利单抗按监管部门要求完成了必要的验证性临床试验，并证明了其在目标人群中的有效性和安全性。
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