智通财经APP讯，同源康医药-B(02410)发布公告，本公司自主研发的新一代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(NMPA)批准附条件上市，适应症为具有表皮生长因子受体(EGFR)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(CNS)转移的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的一线治疗。
甲磺酸氘申艾替尼片是本公司自主研发的新一代高选择性、不可逆口服 EGFR-TKI，为奥希替尼差异化氘代创新品种。药物通过独特的结构优化，有效减少毒性代谢产物生成，具备更优的药代动力学特征，在EGFR 19del和L858R敏感突变肺癌脑转人群中展现出突出的临床疗效与安全性优势。目前本公司已围绕该产品布局多项单药及联合用药临床研究，全面覆盖晚期非小细胞肺癌各类细分适应症。
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