中国批准了 " Libevitug " ,这是Huhahui Health开发的对慢性D型肝炎的首例治疗。 China approved Libevitug, a first-of-its-kind treatment for chronic hepatitis D, developed by Huahui Health.

中国已经批准了Libevitug, 这是由北京华辉健康公司开发的首个针对慢性D型肝炎的单克隆抗体治疗方案。 China has approved Libevitug, a first-of-its-kind monoclonal antibody treatment for chronic hepatitis D, developed by Beijing-based Huahui Health. 国家医疗产品管理局对患有这种疾病的成年人,包括有补偿性肾硬化症的成年人,给予有条件的批准。 The National Medical Products Administration granted conditional approval for adults with the disease, including those with compensated cirrhosis. 在乙型肝炎病毒和D型肝炎病毒上阻断了Pres1域的药物,防止肝细胞进入临界点,因为HDV依赖HBV复制。 The drug blocks the PreS1 domain on the hepatitis B and D virus, preventing liver cell entry—critical since HDV depends on HBV to replicate. 临床试验显示,48周的综合反应率为44.1%,病毒反应率为60%。 Clinical trials showed a 44.1% combined response rate and 60% virological response at 48 weeks. 这一发展植根于2012年发现的病毒受体,反映了从基础科学到市场的一个罕见的全链创新旅程。 The development, rooted in a 2012 discovery of the virus receptor, reflects a rare full-chain innovation journey from basic science to market. 这项批准是中国于2025年批准的创纪录的76种创新药物的一部分,其中多数现在由国家偿还,表明国内生物制药发展能力不断提高。 The approval is part of a record 76 innovative drugs approved in China in 2025, most now covered by national reimbursement, signaling growing domestic capabilities in biopharmaceutical development.