“Hepatitis B Virus (HBV) Infection Pipeline Insight, 2026“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Hepatitis B Virus (HBV) Infection Market.
The Hepatitis B Virus (HBV) Infection Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.
Some of the key takeaways from the Hepatitis B Virus (HBV) Infection Pipeline Report:
Companies across the globe are diligently working toward developing novel Hepatitis B Virus (HBV) Infection treatment therapies with a considerable amount of success over the years.
Hepatitis B Virus (HBV) Infection companies working in the treatment market are Arbutus Biopharma, GSK/Ionis Pharmaceuticals, Vir Biotechnology, Dong-A ST Co., Ltd., Barinthus Biotherapeutics, GC Biopharma Corp, Brii Biosciences Limited, Vir Biotechnology, Inc., Arbutus Biopharma Corporation, Erasmus Medical Center, Daewoong Pharmaceutical Co., Ascletis Pharmaceuticals, Gilead Sciences, Fujian Akeylink Biotechnology, Chia Tai Tianqing Pharma, Janssen Research & Development, LLC, Hoffmann-La Roche, Chengdu Suncadia Medicine, Suzhou Ribo Life Science, Arbutus Biopharma Corporation, Ascentage Pharma Group, and others, are developing therapies for the Hepatitis B Virus (HBV) Infection treatment
Emerging Hepatitis B Virus (HBV) Infection therapies in the different phases of clinical trials are- AB-729, Bepirovirsen, Elebsiran, GSK3965193, DA-2803, ChAdOx1-HBV, Undiluted I.V.-Hepabig inj(GC5103), PEG-IFNα, VIR-3434, AB-729, ISA104, Vemliver tablet, ASC22, TAF, GST-HG131, TQA3605 tablets, JNJ-73763989, Nucleos(t)ide (NUC), HRS9950 tablets, RBD1016, Imdusiran, APG-1387, and others are expected to have a significant impact on the Hepatitis B Virus (HBV) Infection market in the coming years.
In October 2026, Aligos Therapeutics’ Phase II B-SUPREME study is evaluating once-daily oral ALG-000184 against tenofovir disoproxil fumarate in adults with chronic HBV infection who are untreated or not currently receiving treatment. The study includes both HBeAg-positive and HBeAg-negative participants. The trial was listed as active but not recruiting in its September 2026 update, with topline results anticipated in 2027.
In October 2026, bepirovirsen remains under FDA Priority Review for chronic HBV infection, with an assigned PDUFA target action date of October 26, 2026. The decision is expected to be an important regulatory milestone following positive Phase III B-Well trial results. The therapy has also received FDA Breakthrough Therapy Designation. The FDA decision should be verified before reporting any approval announcement.
In August 2026, Japan’s Ministry of Health, Labour and Welfare approved Hibsago (bepirovirsen) for chronic HBV infection in eligible adults. Developed by GSK, the antisense oligonucleotide became the first globally approved treatment specifically intended to achieve a functional cure for chronic hepatitis B. The approval was supported by the Phase III B-Well 1 and B-Well 2 trials and represents an important milestone in HBV drug development. This was a Japanese regulatory approval, not US FDA approval
In June 2026, Detailed Phase III results from B-Well 1 and B-Well 2 were published in The New England Journal of Medicine. The studies evaluated a 24-week course of bepirovirsen alongside standard nucleos(t)ide analogue therapy, followed by assessment of sustained response after treatment withdrawal in eligible participants. The findings strengthened the clinical evidence for a potential functional cure in a subset of patients with chronic HBV infection.
In May 2026, GSK and Ionis Pharmaceuticals announced positive results from the Phase III B-Well 1 and B-Well 2 trials of bepirovirsen in adults with chronic HBV infection. The studies demonstrated functional cure rates of 20% and 19%, respectively, compared with 0% in the placebo groups. Functional cure was assessed through sustained loss of hepatitis B surface antigen and undetectable HBV DNA after treatment cessation. These findings support bepirovirsen’s potential as a finite-duration treatment, although regulatory approval remained pending.
In April 2026, Aligos Therapeutics reported the first interim analysis from the Phase II B-SUPREME study. The independent Data Safety Monitoring Board recommended increasing enrollment in the HBeAg-negative cohort to improve statistical power. The study’s futility criteria were not met, and the treatment was reported to be well tolerated. Topline results remained anticipated in 2027.
In April 2026, GSK announced that the US FDA accepted its New Drug Application (NDA) for bepirovirsen under Priority Review and granted the investigational antisense oligonucleotide Breakthrough Therapy Designation for chronic HBV infection. The FDA assigned an October 26, 2026, target action date. The application was supported by results from the Phase III B-Well 1 and B-Well 2 trials.
In January 2026, Aligos Therapeutics reported progress in the Phase II B-SUPREME trial evaluating pevifoscorvir sodium in adults with chronic HBV infection. The company reported that 144 participants were enrolled across the study cohorts and anticipated interim analyses during 2026, with topline data expected in 2027. The investigational therapy is being evaluated for its potential to suppress HBV infection.
Hepatitis B Virus (HBV) Infection Overview
Hepatitis B Virus (HBV) Infection is a viral infection that affects the liver and can cause both acute and chronic liver disease. It spreads through contact with infected blood and bodily fluids, including during childbirth, and sharing contaminated needles. While acute HBV infection may resolve spontaneously, chronic infection can lead to serious complications such as liver cirrhosis, liver failure, and hepatocellular carcinoma. Preventive measures include vaccination, safe injection practices, and screening of high-risk populations. Treatment options for chronic HBV infection include antiviral medications such as tenofovir and entecavir, while ongoing research focuses on developing functional cures that achieve sustained viral control and improve long-term patient outcomes.
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Emerging Hepatitis B Virus (HBV) Infection Drugs Under Different Phases of Clinical Development Include:
AB-729: Arbutus Biopharma
Bepirovirsen: GSK/Ionis Pharmaceuticals
Elebsiran: Vir Biotechnology
GSK3965193: GlaxoSmithKline
DA-2803: Dong-A ST Co., Ltd.
ChAdOx1-HBV: Barinthus Biotherapeutics
Undiluted I.V.-Hepabig inj(GC5103): GC Biopharma Corp
PEG-IFNα: Brii Biosciences Limited
VIR-3434: Vir Biotechnology, Inc.
AB-729: Arbutus Biopharma Corporation
ISA104: Erasmus Medical Center
Vemliver tablet: Daewoong Pharmaceutical Co. LTD.
ASC22: Ascletis Pharmaceuticals
TAF: Gilead Sciences
GST-HG131: Fujian Akeylink Biotechnology
TQA3605 tablets: Chia Tai Tianqing Pharma
JNJ-73763989: Janssen Research & Development, LLC
Nucleos(t)ide (NUC): Hoffmann-La Roche
HRS9950 tablets: Chengdu Suncadia Medicine
RBD1016: Suzhou Ribo Life Science
Imdusiran: Arbutus Biopharma Corporation
APG-1387: Ascentage Pharma Group
Hepatitis B Virus (HBV) Infection Emerging Therapy Assessment:
Imdusiran (AB-729): Arbutus Biopharma
Imdusiran is an RNAi therapeutic specifically designed to reduce all HBV viral proteins and antigens, including HBsAg. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated NAcetylgalactosamine (GalNAc) delivery technology, enabling subcutaneous delivery.
GSK3228836 (bepirovirsen): GlaxoSmithKline
GSK3228836 (bepirovirsen) is a triple-action investigational Antisense Oligonucleotide (ASO), currently being evaluated in the B-Well phase III clinical trial programme for the treatment of CHB.
Hepatitis B Virus (HBV) Infection Route of Administration
Hepatitis B Virus (HBV) Infection pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
Oral
Parenteral
Intravenous
Subcutaneous
Topical
Hepatitis B Virus (HBV) Infection Molecule Type
Hepatitis B Virus (HBV) Infection Products have been categorized under various Molecule types, such as
Monoclonal Antibody
Peptides
Polymer
Small molecule
Gene therapy
Hepatitis B Virus (HBV) Infection Pipeline Therapeutics Assessment
Hepatitis B Virus (HBV) Infection Assessment by Product Type
Hepatitis B Virus (HBV) Infection By Stage and Product Type
Hepatitis B Virus (HBV) Infection Assessment by Route of Administration
Hepatitis B Virus (HBV) Infection By Stage and Route of Administration
Hepatitis B Virus (HBV) Infection Assessment by Molecule Type
Hepatitis B Virus (HBV) Infection by Stage and Molecule Type
DelveInsight’s Hepatitis B Virus (HBV) Infection Report covers around 90+ products under different phases of clinical development like
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
Route of Administration
Further Hepatitis B Virus (HBV) Infection product details are provided in the report. Download the Hepatitis B Virus (HBV) Infection pipeline report to learn more about the emerging Hepatitis B Virus (HBV) Infection therapies
Some of the key companies in the Hepatitis B Virus (HBV) Infection Therapeutics Market include:
Key companies developing therapies for Hepatitis B Virus (HBV) Infection are – Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, Vir Biotechnology, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Gilead Sciences, Dong-A ST Co., Ltd., Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, and others.
Hepatitis B Virus (HBV) Infection Pipeline Analysis:
The Hepatitis B Virus (HBV) Infection pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Hepatitis B Virus (HBV) Infection with aggregate therapies developed by each company for the same.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hepatitis B Virus (HBV) Infection Treatment.
Hepatitis B Virus (HBV) Infection key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Hepatitis B Virus (HBV) Infection Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hepatitis B Virus (HBV) Infection market.
The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
Download Sample PDF Report to know more about Hepatitis B Virus (HBV) Infection drugs and therapies
Hepatitis B Virus (HBV) Infection Pipeline Market Drivers
High prevalence of chronic HBV infection, increasing Research and development in Chronic Hepatitis B are some of the important factors that are fueling the Hepatitis B Virus (HBV) Infection Market.
Hepatitis B Virus (HBV) Infection Pipeline Market Barriers
However, high cost of treatment, limited access to the diagnosis of hepatitis B and other factors are creating obstacles in the Hepatitis B Virus (HBV) Infection Market growth.
Scope of Hepatitis B Virus (HBV) Infection Pipeline Drug Insight
Coverage: Global
Key Hepatitis B Virus (HBV) Infection Companies: Arbutus Biopharma, GSK/Ionis Pharmaceuticals, Vir Biotechnology, Dong-A ST Co., Ltd., Barinthus Biotherapeutics, GC Biopharma Corp, Brii Biosciences Limited, Vir Biotechnology, Inc., Arbutus Biopharma Corporation, Erasmus Medical Center, Daewoong Pharmaceutical Co., Ascletis Pharmaceuticals, Gilead Sciences, Fujian Akeylink Biotechnology, Chia Tai Tianqing Pharma, Janssen Research & Development, LLC, Hoffmann-La Roche, Chengdu Suncadia Medicine, Suzhou Ribo Life Science, Arbutus Biopharma Corporation, Ascentage Pharma Group, and others
Key Hepatitis B Virus (HBV) Infection Therapies: AB-729, Bepirovirsen, Elebsiran, GSK3965193, DA-2803, ChAdOx1-HBV, Undiluted I.V.-Hepabig inj(GC5103), PEG-IFNα, VIR-3434, AB-729, ISA104, Vemliver tablet, ASC22, TAF, GST-HG131, TQA3605 tablets, JNJ-73763989, Nucleos(t)ide (NUC), HRS9950 tablets, RBD1016, Imdusiran, APG-1387, and others
Hepatitis B Virus (HBV) Infection Therapeutic Assessment: Hepatitis B Virus (HBV) Infection current marketed and Hepatitis B Virus (HBV) Infection emerging therapies
Hepatitis B Virus (HBV) Infection Market Dynamics: Hepatitis B Virus (HBV) Infection market drivers and Hepatitis B Virus (HBV) Infection market barriers
Request for Sample PDF Report for Hepatitis B Virus (HBV) Infection Pipeline Assessment and clinical trials
Table of Contents
1. Hepatitis B Virus (HBV) Infection Report Introduction
2. Hepatitis B Virus (HBV) Infection Executive Summary
3. Hepatitis B Virus (HBV) Infection Overview
4. Hepatitis B Virus (HBV) Infection- Analytical Perspective In-depth Commercial Assessment
5. Hepatitis B Virus (HBV) Infection Pipeline Therapeutics
6. Hepatitis B Virus (HBV) Infection Late Stage Products (Phase II/III)
7. Hepatitis B Virus (HBV) Infection Mid Stage Products (Phase II)
8. Hepatitis B Virus (HBV) Infection Early Stage Products (Phase I)
9. Hepatitis B Virus (HBV) Infection Preclinical Stage Products
10. Hepatitis B Virus (HBV) Infection Therapeutics Assessment
11. Hepatitis B Virus (HBV) Infection Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Hepatitis B Virus (HBV) Infection Key Companies
14. Hepatitis B Virus (HBV) Infection Key Products
15. Hepatitis B Virus (HBV) Infection Unmet Needs
16 . Hepatitis B Virus (HBV) Infection Market Drivers and Barriers
17. Hepatitis B Virus (HBV) Infection Future Perspectives and Conclusion
18. Hepatitis B Virus (HBV) Infection Analyst Views
19. Appendix
20. About DelveInsight
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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