港股异动 | 亚盛医药-B(06855)高开逾4% 利生妥治疗中高危MDS III期临床研究获美国FDA和欧洲EMA批准

智通财经
Aug 18, 2025

智通财经APP获悉,亚盛医药-B(06855)高开逾4%,截至发稿,涨4.53%,报90港元,创历史新高,成交额1689.3万港元。

消息面上,亚盛医药公告,公司自主研发的Bcl-2选择性抑制剂利沙托克拉(商品名:利生妥;研发代码:APG-2575)联合阿扎胞苷(AZA)一线治疗新诊断的中高危骨髓增生异常综合症(HR-MDS)患者的全球注册III期临床研究(GLORA-4)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。作为利生妥在欧美监管机构获批的第二个全球III期研究,GLORA-4在多国家多中心同步入组,将加速新药上市进程。

据悉,利生妥是亚盛医药自主研发的新型口服Bcl-2选择性抑制剂,通过选择性抑制 Bcl-2蛋白,恢复癌细胞的正常凋亡过程,从而达到治疗肿瘤的目的。目前,该产品已在中国获批上市,用于既往经过至少包含布鲁顿酪氨酸激酶(BTK)抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病╱小淋巴细胞淋巴瘤(CLL/SLL)患者。利生妥为中国首个获批上市的国产原创Bcl-2抑制剂。截止本公告日期,利生妥也是国际上唯一正推进中高危MDS注册III期临床的Bcl-2抑制剂。

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