港股异动 | 同源康医药-B(02410)早盘涨超5% 公司正在准备TY-9591附条件上市NDA申请

智通财经
Dec 12, 2025

智通财经APP获悉,同源康医药-B(02410)早盘涨超5%,截至发稿, 涨3.73%,报13.35港元,成交额2154.6万港元。

消息面上,在今年9月份的世界肺癌大会上,同源康医药发布的艾多替尼片针对非小细胞肺癌脑转移关键Ⅱ期临床试验引起同行高度关注。据悉,艾多替尼片(TY-9591)是同源康医药针对EGFR经典突变开发的高选择性小分子抑制剂,公司已于2024年11月完成附条件批准上市资格的224例患者入组,并已于2025年4月提交预上市(Pre-NDA)申请,预计2025年4季度正式提交附条件上市申请。

公司在中期业绩会上表示,目前正在准备TY-9591附条件上市NDA申请,将其用于表皮生长因子受体(EGFR)突变肺癌脑转移的一线治疗,以及正在中国进行TY-9591单药治疗的注册性III期临床试验,将其用于EGFRL858R突变的局部晚期(IIIb至IV期)或转移性NSCLC的一线治疗。

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