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亞盛醫藥(06855.HK):在研原創新藥APG-2575分別在中國、美國獲批三項Ib/II期臨牀試驗
格隆匯 03-09 18:09

格隆匯3月9日丨亞盛醫藥(06855.HK)宣佈,公司在研原創新藥Bcl-2選擇性抑制劑APG-2575日前分別在美國及中國獲批針對三種不同的血液腫瘤適應症開展Ib/II期臨牀研究。

APG-2575是公司開發的新型口服Bcl-2選擇性小分子抑制劑,目前在美國和澳大利亞進行I期臨牀研究,同時也是中國首個進入臨牀研究的國產Bcl-2選擇性抑制劑。試驗迄今未觀察到任何劑量限制性毒性(DLT)以及Bcl-2抑制劑常見的腫瘤溶解綜合徵(TLS),顯示APG2575可能具有良好的安全性。療效方面,截至2019年8月13日,已有一例CLL/SLL患者達到部分緩解(PR)標準;另有三例CLL患者在治療第一週期內,外周血絕對淋巴細胞計數(ALC)即恢復到正常範圍。

美國食品藥品監督管理局(FDA)批准的兩項臨牀試驗分別為APG-2575作為單藥或聯合利妥昔單抗(Rituximab)/Acalabrutinib治療復發/難治慢性淋巴細胞白血病(r/r CLL)/小淋巴細胞淋巴瘤(r/r SLL)的Ib/II期研究,以及APG2575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。中國國家藥品監督管理局(NMPA)藥物審評中心(CDE)批准的一項臨牀試驗為APG2575單藥或聯合治療復發/難治性急性髓系白血病(r/rAML)的Ib期研究。

公司深信,APG2575連續獲得三項Ib/II期臨牀試驗批准,乃是基於該藥物良好的臨牀前數據及早期臨牀數據。公司將積極推進該產品在全球範圍的臨牀試驗,爭取早日上市造福患者。

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