同源康医药TY-9591II期临床试验达到研究预期
3月9日，同源康医药-B（02410）发布公告，宣布其自主研发的TY-9591（商品名：卡达沙®）在对比奥希替尼（商品名：泰瑞沙®）作为一线治疗EGFR突变肺癌脑转移的关键II期临床试验中，达到了研究预期，具有统计学显著意义和重大临床获益。试验结果显示，主要研究终点即颅内客观缓解率(iORR)达到了预期目的，TY-9591在全人群及不同亚组人群中均显示出明显的统计学差异。
本次试验共入组224例受试者，其中19号外显子缺失和21号外显子L858R突变的比例分别为53.1%和46.9%。TY-9591组的总体安全性良好，未出现新的安全性信号。公司计划近期向国家药品监督管理局药品审评中心提交NDA（新药申请）上市申请，进一步推动TY-9591的商业化进程。
（文章来源：财中社）
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