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亞盛醫藥-B(06855.HK)三個在研新藥的六項研究進展入選第63屆美國血液學會年會口頭報吿和壁報展示
格隆匯 11-05 08:05

格隆匯11月5日丨亞盛醫藥-B(06855.HK)發佈公吿,公司共有三個在研新藥(奧雷巴替尼、APG-2575、APG-1252)的六項研究進展入選第63屆美國血液學會(American Society of Hematology,ASH)年會口頭報吿和壁報展示。其中,公司在研原創1類新藥奧雷巴替尼(Olverembatinib,HQP1351,曾用名耐克替尼、奧瑞巴替尼)共有三項臨牀進展入選第63屆美國血液學會(American Society of Hematology,ASH)年會壁報展示及一項獲口頭報吿。北京大學人民醫院血液科黃曉軍教授和江倩教授是該口頭報吿相關研究的主要研究者,江倩教授將在會議期間作此報吿。這是奧雷巴替尼的臨牀進展連續第四年入選ASH年會口頭報吿,充分顯示了國際血液學界對其療效和安全性的認可。此外,公司細胞雕亡品種在研原創1類新藥Bcl-2選擇性抑制劑Lisaftoclax (APG-2575)和Bcl-2/Bcl-xL 雙靶點抑制劑Pelcitoclax (APG-1252)以壁報展示形式,分別公佈了兩項臨牀數據和一項臨牀前研究結果。

根據披露,奧雷巴替尼是亞盛醫藥在研原創1類新藥,是新型的第三代BCR-ABL酪氨酸激酶抑制劑(Tyrosine Kinase Inhibitor,TKI),用於治療對一代、二代TKI耐藥的慢性髓性白血病(CML),特別是對T315I突變的CML患者具有很好的療效。截止該公吿日期,亞盛醫藥在中國遞交的奧雷巴替尼新藥上市申請(NDA)已在審評過程中,用於治療伴有T315I突變的CML慢性期(CML-CP)及加速期(CML-AP)患者,並已被納入優先審評。此外,奧雷巴替尼還獲中國國家藥品監督管理局(NMPA)新藥審評中心(CDE)納入突破性治療品種,擬治療一代和二代TKI耐藥和╱或不耐受的CML-CP患者。

此外,APG-2575治療血液腫瘤的多中心、開放標籤I期單藥研究的數據顯示,APG-2575具有良好的耐受性,無任何腫瘤溶解綜合徵(TLS)發生。截止數據分析截點(2021年7月27日),在25例至少完成了一次腫瘤評估的患者中(共入組31例),有9例獲得了完全緩解(CR)或部分緩解(PR)。接受200mg及以上劑量治療的6例慢性淋巴細胞白血病(CLL)受試者均獲益,為1例CR和5例PR。

每年一度的ASH年會是全球血液學領域規模最大、涵蓋最全面的國際學術盛會之一,匯聚該領域最新、最前沿的研發進展。第63屆ASH年會將於2021年12月11日至14日在美國亞特蘭大以綫下結合綫上的形式舉行。今年,亞盛醫藥共有三個在研新藥(奧雷巴替尼、APG-2575、APG-1252)的六項臨牀研究入選ASH年會展示及報吿。

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