阿斯利康(AZN.US)、安进(AMGN.US)皮下注射TSLP 单抗国内报上市

智通财经
22 Nov 2024

智通财经APP获悉,11 月 22 日,CDE 官网显示,阿斯利康(AZN.US)和安进(AMGN.US)联合递交了 TSLP 单抗特泽利尤单抗注射液的上市申请。根据该药的临床研究进度,推测其本次申报的适应症可能是哮喘。在国内,特泽利尤单抗已完成一项治疗哮喘的 Ⅲ 期临床, 给药频率为每 4 周一次,皮下注射给药。

TSLP 是在与哮喘、慢性鼻窦炎伴鼻息肉、慢性阻塞性肺病、嗜酸性食管炎和其他疾病相关的多种触发因素的反应下释放的。这些患者的 TSLP 表达增加,并且与疾病严重程度相关。阻断 TSLP 可能会阻止免疫细胞释放促炎细胞因子,从而预防病情恶化并改善疾病控制。研究表明,针对气道上皮释放的 TSLP 可能是未来治疗下呼吸道疾病的潜在方法。

研究认为,对于患有严重、未控制哮喘的患者,与安慰剂相比,特泽利尤单抗治疗可增加实现完全临床反应和治疗期间临床缓解的可能性。

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