智通财经APP讯，同源康医药-B(02410)公布，公司自主研发的TY-9591(商品名：卡达沙®)对比奥希替尼(商品名：泰瑞沙®)作为一线治疗EGFR突变肺癌脑转移的关键 II期临床试验根据研究者数据显示具有统计学显著意义和重大临床获益。主要研究终点颅内客观缓解率(iORR)达到预期目的，TY-9591对比奥希替尼显示出统计学显著意义和临床意义的明显改善，无论在全人群还是在不同亚组人群(包括基因分型、颅内病灶个数、ECOG评分等)中均具有明显统计学差异。
公司计划于近期向国家药品监督管理局药品审评中心(CDE)提交NDA (New Drug Application)上市申请。
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