Bepirovirsen Sodium

2026年乙肝药物研发呈现“里程碑突破”与“早期管线淘汰”并存的复杂格局。一方面，GSK的bepirovirsen先后获日本及美国FDA批准，成为全球首个以“功能性治愈”为目标的乙肝新药，关键数据显示其停药后72周治愈率显著优于安慰剂，为特定患者带来希望。另一方面，中国创新药企进展迅猛，正大天晴的两款1类创新药TQ-A3334及TQA3605因在功能性治愈和低病毒血症方面的潜力，被纳入突破性治疗药物程序；智翔金泰的双特异性抗体GR2302也获临床试验批准。尽管多款早期管线因安全或战略原因终止，凸显研发高风险，但整体而言，随着新机制药物的涌现与审批加速，乙肝功能性治愈正从概念走向现实，行业在残酷筛选中迎来实质性进展。

Hibsago was reviewed under Health Canada's Priority Review policy, reflecting its innovation and potential to address a disease with high unmet medical need Approval is based on data from Phase III B-Well trials which demonstrated significant and clinically meaningful functional cure rates An estimated 262,000 people in Canada live with chronic hepatitis B 1 , a leading cause of liver cancer 2 MISSISSAUGA, ON , Nov. 3, 2026 /CNW/ -- GSK announced today that Health Canada has approved Hibsago (bepirovirsen) as a finite treatment to achieve functional cure of chronic hepatitis B (CHB) virus infection in non-cirrhotic adult patients who have been on nucleos(t)ide analogue therapy for at least 6 months and with HBV DNA <90 IU/mL, and have hepatitis B surface antigen (HBsAg) levels ≤3,000 IU/mL. Clinical efficacy is higher with lower baseline HBsAg levels, especially in patients with baseline HBsAg levels ≤1,000 IU/mL. 3 Hibsago is an antisense oligonucleotide (ASO) and the first and only therapy in Canada with an indication to achieve functional cure in CHB . " Hibsago's authorization in Canada represents an important step forward for people living with CHB, a serious, progressive liver disease," says Dr. Michelle Horn, Country Medical Director, GSK Canada. "The possibility of a functional cure delivered through a finite course of therapy changes expectations from lifelong management to the prospect of stopping treatment and supporting long-term liver health. CHB remains an area of high unmet need, and GSK remains committed to advancing hepatology to help address this gap for Canadians living with this disease." Approval in Canada was supported by results from the B-Well phase III trials showing unprecedented functional cure rates of 19% in adults with ≤3000 IU/ml baseline HBsAg and 26% in adults with baseline HBsAg ≤1000 IU/ml, compared with 0% functional cure in the placebo (standard-of-care alone) group. 4 Functional cure occurs when the hepatitis B virus DNA and viral protein – HBsAg – are undetectable for at least 24 weeks after stopping all hepatitis B treatment. This indicates the disease is controlled by the immune system without medication. "For many people in Canada living with CHB, the diagnosis comes with years of worry about liver damage and the impact on work, family and future plans, and it can still carry stigma and misunderstanding in their communities," added Jennifer Nebesky, CEO, Liver Canada. "New options like Hibsago can offer people living with CHB greater confidence about their liver health and help us tackle the ongoing challenges that still affect the CHB community across Canada." CHB is a long-term viral infection, which affects an estimated 262,000 people in Canada. 1 It often goes undetected for years because many people have few or no symptoms, but over time it can lead to serious liver damage, including cirrhosis and liver cancer. 2 Hibsago's approval in Canada was granted under Health Canada's Priority Review policy, reflecting its innovation and potential to address a disease with high unmet medical need. It follows authorizations in Japan and the United States. Hibsago supply is anticipated to become available in Canada to eligible patients in early 2027. About chronic hepatitis B Hepatitis B is a viral infection that can cause both acute and chronic liver disease. Chronic hepatitis B occurs when the immune system is unable to clear the virus, resulting in long-lasting infection that affects an estimated 262,000 people in Canada. The disease causes approximately 1.1 million deaths each year globally. 1 In people with chronic hepatitis B, a loss in hepatitis B surface antigen is associated with up to an 89% reduction in risk of liver cancer and a 62% reduction in risk of all-cause mortality. 5 Many patients require lifelong antiviral therapy for viral suppression, making functional cure a critical goal in disease management. The Canadian Association for the Study of the Liver (CASL) and the Association of Medical Microbiology and Infectious Disease Canada (AMMI) updated guidelines identify functional cure as the optimal goal of treatment. 6 About Hibsago (bepirovirsen) Hibsago (bepirovirsen) is an antisense oligonucleotide (ASO) designed to recognise and inhibit the production of the genetic components (i.e. RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person's immune system to regain control. Hibsago reduces the production of RNA and viral proteins associated with HBV, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulates the immune system to increase the chances of a durable and sustained response. GSK licensed Hibsago (bepirovirsen) from Ionis Pharmaceuticals and collaborated with them on its development. Please consult the Hibsago product monograph at gsk.ca for complete safety information. The product monograph is also available by calling 1-800-387-7374. About B-Well Clinical trial programs B-Well 1 and B-Well 2 trials are global multi-centre, randomised, double-blind, placebo-controlled trials conducted in 29 countries. They assessed the efficacy, safety, pharmacokinetic profile, and the durability of functional cure in nucleos(t)ide analogue (NA)-treated participants with CHB and baseline surface antigen (HBsAg) ≤3000 IU/ml. The primary endpoint assessed the proportion of participants achieving functional cure in patients with baseline surface antigen (HBsAg) ≤3000 IU/ml. Functional cure in patients with baseline HBsAg ≤1000 IU/ml was a key secondary endpoint. Functional cure was defined as sustained suppression (24 weeks or longer) of HBV DNA (