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亞盛醫藥-B(06855.HK):APG-2575連獲兩項中國Ib/II期臨牀試驗許可
格隆匯 11-23 18:20

格隆匯 11 月 23日丨亞盛醫藥-B(06855.HK)發佈公告,公司在研1類新藥Bcl-2抑制劑APG-2575連續獲得國家藥品監督管理局(NMPA)藥物審評中心(CDE)的兩項臨牀試驗許可,將分別開展作為單藥或聯合依魯替尼(Ibrutinib)╱利妥昔單抗(Rituximab)治療華氏巨球蛋白血癥(WM)的Ib/II期研究;以及作為單藥或聯合來那度胺(Lenalidomide)╱地塞米松(Dexamethasone)治療多發性骨髓瘤(MM)的Ib/II 期研究。

APG-2575單藥或聯合依魯替尼(Ibrutinib)╱利妥昔單抗(Rituximab)治療WM患者的Ib/II期研究為全球多中心、開放性Ib/II期劑量療效探索研究,旨在評估APG2575單藥或者聯合依魯替尼(Ibrutinib)╱利妥昔單抗(Rituximab)治療WM患者的安全性、耐受性、藥代動力學特徵及初步的療效觀察。

WM是一種少見的惰性成熟B細胞淋巴瘤,在非霍奇金淋巴瘤(NHL)中所佔比例少於2%。目前指引推薦的WM的治療方案客觀緩解率可達到80%,但是很好部分緩解(VGPR)以上的較深緩解率很低(20%左右或更低),較多患者最終會復發或病情加劇。同時,WM的中位發病年齡在70歲左右,患者身體狀態常常不能夠耐受強烈治療。因此WM治療效果的提高是臨牀迫切需要解決的問題 。

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