葛兰素史克（GSK）的反义寡核苷酸药物bepirovirsen于美国当地时间10月20日获得美国FDA批准，用于治疗无肝硬化的慢性乙型肝炎患者1。这一批准标志着乙肝治疗进入功能性治愈商业化阶段，继该药物在日本获批后的又一重要进展1。
功能性治愈是指停止治疗后至少24周内，乙肝病毒DNA和表面抗原在血液中无法被检出1。根据B-WELL三期临床试验数据，在HBsAg≤3000 IU/ml的患者中，该药物的功能性治愈率达到19%，远超现有标准治疗方案的不足1%水平1。患者经过六个月的治疗疗程后有机会实现功能性治愈，并可自行给药1。
在中国市场方面，bepirovirsen已被纳入优先审评审批程序，预计2027年获批1。中国生物制药子公司正大天晴于今年5月获得该药物在中国的代理权1。同时，国内也有多个乙肝功能性治愈管线正在推进，包括恒瑞医药的HRS-5635、浩博医药的AHB-137和广生堂的GST-HG141等1。
GlaxoSmithKline (GSK) announced on October 20 that its antisense oligonucleotide drug bepirovirsen has received formal approval from the U.S. Food and Drug Administration for treating chronic hepatitis B in patients without cirrhosis 1. This milestone marks the entry of hepatitis B treatment into the commercial stage of functional cure, following the drug's approval in Japan in August 2024 1.
The Phase III clinical trial B-WELL demonstrated that among patients with hepatitis B surface antigen (HBsAg) levels of 3,000 IU/ml or lower, the functional cure rate reached 19%, substantially exceeding the less than 1% cure rate typically achieved with standard therapy after one year of treatment 1. Functional cure is defined as the absence of detectable hepatitis B virus DNA and surface antigen in the blood for at least 24 weeks after stopping treatment 1. Patients have the potential to achieve functional cure following a six-month treatment course and can self-administer the medication 1.
In China, bepirovirsen has been included in the priority review and approval program, with approval anticipated in 2027 1. China Biologic Products, a subsidiary of GSK, received exclusive rights to the drug in China in May 1. Meanwhile, multiple domestic Chinese competitors are advancing their own functional cure pipelines, including Hengrui Pharmaceuticals' HRS-5635, Highvoe Pharma's AHB-137, and Guangsheng Pharma's GST-HG141 1.
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