港股异动 | 中国生物制药(01177)涨超4% 与GSK合作的Bepirovirsen将于EASL 2026公布两项III期临床数据

智通财经

May 29

智通财经APP获悉，中国生物制药(01177)涨超4%，截至发稿，涨3.95%，报5港元，成交额4.28亿港元。

消息面上，5月29日，中国生物制药发布公告，本集团附属公司正大天晴药业集团股份有限公司(正大天晴)与葛兰素史克(GSK)合作的Bepirovirsen，已公布其用于治疗慢性乙型肝炎(CHB)的积极关键数据。

两项三期临床试验B-Well 1(NCT05630807)和B-Well 2(NCT05630820)结果同时在《新英格兰医学杂志》(New England Journal of Medicine)发表，并在2026年欧洲肝病学会(EASL)上展示。在EASL的口头报告中还展示了地区亚组数据。其中，中国亚组数据显示，在HBsAg≤3000 IU/ml的受试者中，功能性治愈为24%;在HBsAg≤1000 IU/ml的受试者中，功能性治愈率达35%。

Bepirovirsen目前正在接受中国(已纳入突破性治疗药物、优先审评审批程序)、美国(已获得优先审评、突破性疗法、快速通道认定)、欧洲、日本(已获得SENKU认定)监管机构的审评审批。GSK预计2027年上半年收到中国国家药品监督管理局的监管决定，目前上市准备工作正在进行中。

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