亞盛醫藥-B(06855.HK)：APG-2575治療復發╱難治性慢性淋巴細胞白血病╱小淋巴細胞淋巴瘤關鍵註冊II期中國臨牀研究獲CDE批准
格隆匯12月13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lisaftoclax(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)的關鍵註冊II期臨牀研究(APG2575CC201)獲得中國國家藥品監督管理局藥物審評中心(CDE)批准。
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，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，達到治療腫瘤的目的。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。APG-2575已在美國、中國、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。在今年的2021年美國血液學會年會上，APG-2575在中國治療血液腫瘤的最新研究數據被首次公佈，展現出良好的耐受性及治療潛力，無任何腫瘤溶解綜合症(TLS)發生。針對接受200mg及以上劑量治療的6例CLL受試者，獲得100% ORR，並呈現1例完全緩解(CR)。
全球CLL/SLL治療領域仍存在巨大的未被滿足的治療需求。對於復發難治的CLL/SLL患者而言，尤其是免疫化療及BTK抑制劑治療失敗或不耐受的CLL/SLL人羣，疾病進展快速，目前尚無有效治療手段因而迫切需要一種新的治療方法。
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