百濟神州(688235.SH):百悦澤®(澤布替尼膠囊)獲歐洲藥品管理局人用藥品委員會積極意見
格隆匯10月14日丨百濟神州(688235.SH)公佈,歐洲藥品管理局(EMA)人用藥品委員會(CHMP)近日發佈其推薦公司產品百悦澤®(澤布替尼膠囊)獲得上市許可的積極意見,建議批准百悦澤®用於治療慢性淋巴細胞白血病(CLL)成人患者。
百悦澤®(澤布替尼膠囊)是一款由公司科學家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。
百濟神州的願景是致力於提供可負擔的創新藥物。獲得CHMP的積極意見,使得百悦澤?有望獲得批准併為CLL成人患者帶來新的治療選擇,有助於進一步提升該藥物的可及性。
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