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亚盛医药-B(06855.HK):APG-2575连获两项中国Ib/II期临床试验许可
格隆汇 11-23 18:20

格隆汇 11 月 23日丨亚盛医药-B(06855.HK)发布公告,公司在研1类新药Bcl-2抑制剂APG-2575连续获得国家药品监督管理局(NMPA)药物审评中心(CDE)的两项临床试验许可,将分别开展作为单药或联合依鲁替尼(Ibrutinib)╱利妥昔单抗(Rituximab)治疗华氏巨球蛋白血症(WM)的Ib/II期研究;以及作为单药或联合来那度胺(Lenalidomide)╱地塞米松(Dexamethasone)治疗多发性骨髓瘤(MM)的Ib/II 期研究。

APG-2575单药或联合依鲁替尼(Ibrutinib)╱利妥昔单抗(Rituximab)治疗WM患者的Ib/II期研究为全球多中心、开放性Ib/II期剂量疗效探索研究,旨在评估APG2575单药或者联合依鲁替尼(Ibrutinib)╱利妥昔单抗(Rituximab)治疗WM患者的安全性、耐受性、药代动力学特征及初步的疗效观察。

WM是一种少见的惰性成熟B细胞淋巴瘤,在非霍奇金淋巴瘤(NHL)中所占比例少于2%。目前指引推荐的WM的治疗方案客观缓解率可达到80%,但是很好部分缓解(VGPR)以上的较深缓解率很低(20%左右或更低),较多患者最终会复发或病情加剧。同时,WM的中位发病年龄在70岁左右,患者身体状态常常不能够耐受强烈治疗。因此WM治疗效果的提高是临床迫切需要解决的问题 。

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