南京新百(600682.SH):上海丹瑞Sipuleucel-T注射液获批临试
格隆汇8月5日丨南京新百(600682.SH)宣布,公司控股子公司上海丹瑞生物于近日获得了国家药品监督管理局颁发的《药物临床试验批准通知书》。药物名称为Sipuleucel-T注射液;受理号为CXSL2000098。
根据《中华人民共和国药品管理办法》及有关规定,经审查,2020年5月6日受理的Sipuleucel-T注射液符合药品注册的有关要求,同意按照提交的临床试验方案开展“评价Sipuleucel-T注射液在中国无症状或轻微症状的转移性去势抵抗性前列腺癌患者中的安全性和产品参数的单臂、多中心、开放性临床研究”。
美国Dendreon Pharmaceuticals LLC.的Sipuleucel-T细胞注射液(商品名Provenge),主要用于治疗成年男性的无症状或轻微症状的转移性去势抵抗性前列腺癌(mCRPC)。2010年4月,Provenge获美国FDA(食品药品监督管理局)批准于美国上市,是全球首个获批上市的治疗实体瘤的细胞免疫治疗药物。2013年9月,Provenge获欧洲EMA(欧洲药品管理局)批准于欧洲上市。2015年5月,出于运营策略考虑,Provenge从欧洲撤市。
截至目前,Provenge仍为全球唯一用于治疗前列腺癌的已上市细胞免疫治疗药物,中国境内尚无同类药物获批上市。
上海丹瑞生物已获得与该产品相关的全部知识产权授权,现拟于中国境内(不包括港澳台地区)进行申报上市。
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