和黄医药指中国药监局已受理索凡替尼之新药上市申请
和黄医药公布,中国药监局已受理索凡替尼(surufatinib)用於治疗晚期非胰腺神经内分泌瘤的新药上市申请,是次新药上市申请是基於成功的SANET-ep临床研究数据。SANET-ep是一项关於索凡替尼以晚期非胰腺神经内分泌瘤为适应症的III 期关键性研究,而这些患者目前尚无有效治疗方法。该项研究的阳性结果早前在2019年9月29日举行的欧洲肿瘤内科学会(ESMO)年会上以口头报告的形式公布。
和黄医药首席执行官贺隽(Christian Hogg)表示,提交新药上市申请意味着索凡替尼有望在中国获批及上市,为治疗方法选择非常有限的众多患者带来一种新的治疗选择。为了尽可能在让索凡替尼在获批後惠及更多患者,公司目前正在组建自己的肿瘤药物商业化团队,并期望在索凡替尼上市之时便准备就绪,覆盖中国所有相关的医院及诊所。
和黄医药现时拥有索凡替尼在全球范围内的所有权利,索凡替尼正在中国、美国及欧洲作为单药治疗或与其他肿瘤免疫疗法联合治疗开展针对多种实体瘤的研究。
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