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Therakos 在欧洲获 MDR 批准,为对皮质类固醇反应不足的患者提供免疫相关不良事件治疗

都柏林 2026年10月22日 /美通社/ -- Therakos Development Limited 是通过体外光分离疗法(ECP)在床旁提供免疫调节治疗的全球先驱。公司今日宣布,其 THERAKOS™ CELLEX™ 光分离治疗系统已依据欧盟《医疗器械法规》(MDR)获得扩展适应证认证。该系统现已在欧洲获准用于治疗对皮质类固醇反应不足的成年患者因免疫检查点抑制剂(ICI)治疗而出现的免疫相关不良事件(irAE)。这是全球首个、也是唯一获批用于这一用途的疗法。 ICI 疗法通过调动免疫系统,产生持久的抗肿瘤反应,改变了癌症治疗。然而,同样的免疫激活作用也可能引发严重的 irAE,影响治疗的持续开展及患者预后。皮质类固醇仍是处理…

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