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亞盛醫藥(06855.HK)Bcl-2抑制劑利生妥獲國家藥監局批準上市
阿思達克 07-10 17:00
亞盛醫藥(06855.HK)公佈,其自主研發的新型Bcl-2選擇性抑制劑利生妥(利沙託克拉)(APG-2575)獲國家藥監局附條件批準上市,用於既往經過至少包含布魯頓酪氨酸激(酉每)(BTK)抑制劑在內的一種系統治療的成人慢性淋巴細胞白血病╱小淋巴細胞淋巴瘤(CLL/SLL)患者,意味着國產原創利生妥成爲中國首個上市用於治療CLL/SLL的Bcl-2抑制劑,也是全球第二個上市的Bcl-2抑制劑。 公司指,利生妥是繼耐立克之後其第2個獲批上市、進入商業化階段的原創新藥。目前,公司正在開展利沙託克拉四項全球註冊III期臨牀研究,分別爲獲美國FDA許可的治療經治CLL/SLL患者的GLORA研究;治療初治CLL/SLL患者的GLORA-2研究;治療新診斷老年或體弱急性髓系白血病(AML)的GLORA-3研究;以及治療新診斷中高危骨髓增生異常綜合徵(MDS)患者的GLORA-4研究。
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