亞盛醫藥-B(06855.HK):Bcl-2選擇性抑制劑APG-2575中國關鍵註冊II期臨牀試驗完成首例患者給藥
格隆匯3月15日丨亞盛醫藥-B(06855.HK)發佈公吿,公司在研原創1類新藥Bcl-2 選擇性抑制劑APG-2575治療復發╱難治性慢性淋巴細胞白血病╱小淋巴細胞淋巴瘤(R/R CLL/SLL)的中國關鍵註冊II期臨牀試驗(APG2575CC201)已完成首例患者給藥,是全球第2個進入註冊臨牀階段的Bcl-2抑制劑。
根據披露,APG2575CC201是一項在R/R CLL/SLL患者中進行的單臂、開放性關鍵註冊II期臨牀研究,用於評估APG-2575的有效性和安全性。該研究的主要終點指標為總緩解率(ORR)。基於APG-2575目前已獲得的安全性、有效性數據,國家藥品監督管理局藥物審評中心(CDE)已同意APG2575CC201的研究結果將支持未來適應症R/R CLL/SLL的上市申請。
APG-2575是亞盛醫藥在研的新型口服Bcl-2選擇性小分子抑制劑,通過選擇性抑制Bcl-2蛋白來恢復腫瘤細胞程序性死亡機制(細胞凋亡),從而誘導腫瘤細胞凋亡,達到治療血液腫瘤和實體瘤的目的。APG-2575是首個在中國進入臨牀階段的、本土研發的Bcl-2選擇性抑制劑,也是全球第2個進入註冊臨牀階段的 Bcl-2抑制劑。APG-2575目前已在中國、美國、澳大利亞、歐洲等全球多地開展包括CLL/SLL在內的多種血液腫瘤和實體瘤的臨牀研究。
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