亞盛醫藥-B(06855.HK)抗耐藥白血病新藥奧瑞巴替尼臨牀進展第三次入選美國血液學會年會口頭報告
格隆匯 11 月 9日丨亞盛醫藥-B(06855.HK)發佈公告,公司的原創1類新藥新型BCR-ABL抑制劑HQP1351(擬定中文通用名:奧瑞巴替尼)的關鍵性註冊II期臨牀研究結果入選第62屆美國血液學會(American Society of Hematology (ASH))年會的口頭報告。北京大學人民醫院血液科黃曉軍教授和江倩教授是本研究的主要研究者,江倩教授將在會議期間作此報告。這是繼2018、2019年之後, HQP1351的臨牀進展第三次入選ASH年會口頭報告。連續三年入選,充分顯示了國際血液學界對HQP1351療效和安全性的認可。
HQP1351是亞盛醫藥在研原創1類新藥,為新型的第三代酪氨酸激酶抑制劑(TKI),用於治療對一代、二代TKI耐藥的慢性髓性白血病(CML)患者。本次入選口頭報告的臨牀進展為HQP1351在針對伴有T315I突變的TKI耐藥的CML患者中進行的兩項關鍵性註冊II期臨牀研究結果。截至2020年3月23日,關鍵性註冊 II期臨牀研究HQP1351-CC201共納入41例慢性髓性白血病慢性期(CML-CP)患者;截至2020年2月11日,關鍵性註冊II期臨牀研究HQP1351-CC202共納入23例慢性髓性白血病加速期(CML-AP)患者。這兩項研究數據顯示,HQP1351在伴有T315I 突變的TKI耐藥的CML-CP及CML-AP患者中均具有良好的療效及耐受性。
基於兩項關鍵性註冊II期臨牀研究的結果,亞盛醫藥今年已在中國遞交HQP1351的新藥上市申請(NDA),用於治療伴有T315I突變的CML-CP及CML-AP患者,並已被納入優先審評。
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