2026年8月27日，同源康医药-B（02410）发布自愿公告称，其自主研发的新一代EGFR-TKI创新药甲磺酸氘申艾替尼片（TY-9591片）已获得中国国家药品监督管理局附条件上市批准。该药适用于携带表皮生长因子受体外显子19缺失（19DEL）或外显子21（L858R）置换突变，并伴有中枢神经系统转移的局部晚期或转移性非小细胞肺癌成人患者的一线治疗。
甲磺酸氘申艾替尼片为高选择性、不可逆口服EGFR-TKI，是在奥希替尼基础上进行氘代改造的差异化新品种。通过独特结构优化，该药可减少毒性代谢产物生成，并表现出更优的药代动力学特征。公告显示，在EGFR 19DEL及L858R突变并伴脑转移的肺癌患者中，该药展现出突出临床疗效和安全性优势。
公司目前已围绕该产品布局多项单药及联合用药临床研究，覆盖晚期非小细胞肺癌的多类细分适应症。
同源康医药-B提醒，尚无法保证甲磺酸氘申艾替尼片最终能够成功商业化，投资者买卖公司股份时需审慎行事。
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