君实生物(01877.HK)单抗药物新适应症上市申请获批准
君实生物(01877.HK)公布,收到国家药监局核准签发的《药品注册证书》,特瑞普利单抗(商品名:拓益,产品代号:JS001)用於含铂化疗失败包括新辅助或辅助化疗12个月内进展的局部晚期或转移性尿路上皮癌的治疗的新适应症上市申请获得附条件批准。
特瑞普利单抗是中国首个批准上市的以PD-1为靶点的国产单抗药物,至今已在中、美等多国开展了覆盖超过15个适应症的30多项临床研究。
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