百濟神州(688235.SH):NICE推薦百悦澤®(澤布替尼膠囊)用於治療既往接受過至少一種治療的華氏巨球蛋白血癥患者
格隆匯9月20日丨百濟神州(688235.SH)公佈,英國衞生技術評估機構英國國家衞生與臨牀優化研究所(NICE)發佈最終評估文件,推薦公司產品百悦澤®(澤布替尼膠囊)用於治療既往接受過至少一種治療且適用於苯達莫司汀-利妥昔單抗聯合用藥的華氏巨球蛋白血癥(WM)成人患者。
百悦澤®(澤布替尼膠囊)是一款由公司自主研發的布魯頓氏酪氨酸激酶(BTK)小分子抑制劑,目前正在全球進行廣泛的臨牀試驗項目,作為單藥和與其他療法進行聯合用藥治療多種B細胞惡性腫瘤。由於新的BTK會在人體內不斷合成,百悦澤®的設計通過優化生物利用度、半衰期和選擇性,實現對BTK蛋白靶向、持續的抑制。憑藉與其他獲批BTK抑制劑存在差異化的藥代動力學,百悦澤®能在多個疾病相關組織中抑制惡性B細胞增殖。
NICE發佈最終評估文件,推薦百悦澤®用於治療既往接受過至少一種治療且適用於苯達莫司汀-利妥昔單抗聯合用藥的華氏巨球蛋白血癥(WM)成人患者。在此次評估中,NICE認為百悦澤®可被視為WM治療的一項“重大進步”。臨牀證據顯示,與標準療法相比,接受百悦澤®治療的WM患者生存期更長,且生活質量更高。NICE認為百悦澤®具有成本優勢,其每個質量調整生命年(QALY)的治療費用最低僅為2萬英鎊至3萬英鎊。
公司表示,百濟神州的願景是致力於提供可負擔的創新藥物。NICE的決定標誌着百悦澤®成為英格蘭和威爾士地區首個也是唯一一個被推薦用於治療WM的常規藥物,有助於進一步提升該藥物的可及性。
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