港股异动 | 亚盛医药-B(06855)涨超6% 耐立克®POLARIS-1研究获美国FDA和欧洲EMA批准

智通财经
Dec 05

智通财经APP获悉,亚盛医药-B(06855)涨超6%,截至发稿,涨5.67%,报64.2港元,成交额1993.31万港元。

消息面上,12月5日,亚盛医药-B发布公告,公司原创1类新药奥雷巴替尼(商品名:耐立克®)联合化疗治疗新诊断费城染色体阳性(Ph+)急性淋巴细胞白血病(ALL)患者的全球注册III期临床研究(POLARIS-1,NCT06051409)获美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)同意开展。作为耐立克®在欧美监管机构获批的第二个全球注册III期研究,POLARIS-1研究在多国家多中心同步入组,将加速耐立克®全球特别是欧美市场的上市进程。

值得一提的是,POLARIS-1研究的最新进展也将在即将召开的2025年美国血液学会( American Society of Hematology,ASH)年会上亮相,这是该研究数据的首次公布。目前已披露的摘要数据显示:在耐立克®联合低强度化疗治疗的初治Ph+ ALL患者中,三周期分子MRD(微小残留病)阴性率、分子MRD阴性CR(完全缓解)率均可达65%左右,较国外同类产品在同样条件下的疗效明显提升;即使是对一些高危亚型如携带IKZF1plus基因变异的患者也达到了很好的疗效。同时,该联合方案的安全性表现优异,副作用发生率低且可控制。

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