亚盛医药-B(06855.HK)抗耐药白血病新药奥瑞巴替尼临床进展第三次入选美国血液学会年会口头报告
格隆汇 11 月 9日丨亚盛医药-B(06855.HK)发布公告,公司的原创1类新药新型BCR-ABL抑制剂HQP1351(拟定中文通用名:奥瑞巴替尼)的关键性注册II期临床研究结果入选第62届美国血液学会(American Society of Hematology (ASH))年会的口头报告。北京大学人民医院血液科黄晓军教授和江倩教授是本研究的主要研究者,江倩教授将在会议期间作此报告。这是继2018、2019年之后, HQP1351的临床进展第三次入选ASH年会口头报告。连续三年入选,充分显示了国际血液学界对HQP1351疗效和安全性的认可。
HQP1351是亚盛医药在研原创1类新药,为新型的第三代酪氨酸激酶抑制剂(TKI),用于治疗对一代、二代TKI耐药的慢性髓性白血病(CML)患者。本次入选口头报告的临床进展为HQP1351在针对伴有T315I突变的TKI耐药的CML患者中进行的两项关键性注册II期临床研究结果。截至2020年3月23日,关键性注册 II期临床研究HQP1351-CC201共纳入41例慢性髓性白血病慢性期(CML-CP)患者;截至2020年2月11日,关键性注册II期临床研究HQP1351-CC202共纳入23例慢性髓性白血病加速期(CML-AP)患者。这两项研究数据显示,HQP1351在伴有T315I 突变的TKI耐药的CML-CP及CML-AP患者中均具有良好的疗效及耐受性。
基于两项关键性注册II期临床研究的结果,亚盛医药今年已在中国递交HQP1351的新药上市申请(NDA),用于治疗伴有T315I突变的CML-CP及CML-AP患者,并已被纳入优先审评。
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