Chronic Hepatitis B Virus Pipeline: 50+ Companies Driving Next-Generation Therapies and Disease Management | DelveInsight

The therapeutic landscape for Chronic Hepatitis B Virus (HBV) infection, a globally prevalent and potentially life-threatening liver disease, is rapidly evolving with innovative treatment candidates from leading pharmaceutical and biotechnology companies. Major industry players, including Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, and Antios Therapeutics, are spearheading the development of novel antiviral and immune-modulating therapies designed to achieve functional cure and long-term viral suppression.

DelveInsight's "Chronic Hepatitis B Virus - Pipeline Insight, 2025" offers an in-depth analysis of the current clinical development pipeline, encompassing investigational drugs from early discovery to late-stage clinical trials. This comprehensive report examines mechanisms of action targeting viral replication, cccDNA elimination, and immune system restoration, as well as therapeutic modalities including small molecules, therapeutic vaccines, and RNA interference agents.

Providing a 360° perspective, the report details drug profiles, clinical trial phases, delivery routes, and expected timelines for regulatory approval and market launch. It also highlights unmet medical needs, strategic collaborations, regulatory milestones such as fast-track and orphan designations, and evolving market dynamics that are set to transform the management and prognosis of Chronic Hepatitis B infection.

Interested in learning more about the current treatment landscape and the key drivers shaping the chronic hepatitis B virus pipeline? Click here: https://www.delveinsight.com/report-store/chronic-hepatitis-b-virus-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Chronic Hepatitis B Virus Pipeline Report
• DelveInsight's chronic hepatitis B virus pipeline analysis depicts a strong space with 50+ active players working to develop 55+ pipeline drugs for Chronic Hepatitis B Virus treatment.
• The leading chronic hepatitis B virus companies include Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, 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, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, and others are evaluating their lead assets to improve the chronic hepatitis B virus treatment landscape.
• Key chronic hepatitis B virus pipeline therapies in various stages of development include Pradefovir, DA 2802, VIR-2218, AB-729, Selgantolimod, ATI-2173, ASC42, Hepalatide, QL-007, Antroquinonol, HEC121120, APG-1387, GSK3228836, JNJ-73763989, JNJ-56136379, Vonafexor, T101, BRII-179, aVTP-300, PA1010, P1101, NCO-48, HRS5091, EDP-514, CKD-388, LP-128, VNRX 9945, ZM-H1505R, ISA104, RG6346, HepTcell, RO7049389, RO7020531, and others.
• In April 2025, Precision BioSciences (Nasdaq: DTIL) announced that the FDA granted Fast Track designation to PBGENE-HBV, its lead in vivo gene editing therapy aimed at curing chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA.
• In March 2025, Precision BioSciences announced FDA clearance of its IND application for PBGENE-HBV, a meganuclease-edited in vivo therapy aimed at curing chronic hepatitis B.
• In January 2025, Bluejay Therapeutics, a clinical-stage biopharmaceutical company, announced that its lead drug candidate, brelovitug (BJT-778), received Breakthrough Therapy Designation from the US FDA. Brelovitug targets chronic hepatitis delta (CHD), a serious viral liver disease.
• In December 2024, Vir Biotechnology, Inc. announced that tobevibart and elebsiran received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of chronic hepatitis delta (CHD).

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Chronic Hepatitis B Virus Overview
Hepatitis B virus (HBV) infection is a serious global health issue, causing potentially life-threatening liver disease. It spreads primarily through contact with infected body fluids such as blood, semen, and vaginal secretions. While over 95% of healthy adults can naturally clear the virus, infection may range from acute symptomatic illness to an asymptomatic state detected during routine screening. Clinical symptoms vary widely: acute infection can present as mild or severe hepatitis, including rare cases of fulminant hepatitis, while chronic infection may lead to an asymptomatic carrier state, ongoing liver inflammation, cirrhosis, or liver cancer. Transmission occurs through percutaneous exposure or mucosal contact with infectious fluids.

Find out more about chronic hepatitis B virus medication @ https://www.delveinsight.com/report-store/chronic-hepatitis-b-virus-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Chronic Hepatitis B Virus Treatment Analysis: Drug Profile
Pradefovir: Ligand Pharmaceuticals
Pradefovir is an oral prodrug that targets the liver and converts into adefovir, an HBV DNA polymerase/reverse transcriptase inhibitor. It is being developed using Ligand's HepDirect technology and is currently in Phase III trials for treating chronic hepatitis B.

RG6346: Dicerna Pharmaceuticals
RG6346 is an investigational GalXCTM RNA interference (RNAi) therapy being developed in collaboration with Roche for chronic HBV infection. It works by selectively silencing genes responsible for HBV mRNA production and viral entry into liver cells. Preclinical studies showed over 99.9% reduction in circulating HBsAg in mouse models. Unlike existing treatments that mainly suppress the virus, RG6346 aims to provide a functional cure. It is currently in Phase II clinical trials in adults with chronic HBV.

Learn more about the novel and emerging chronic hepatitis B virus pipeline therapies @ https://www.delveinsight.com/report-store/chronic-hepatitis-b-virus-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Chronic Hepatitis B Virus Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

By Molecule Type
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Scope of the Chronic Hepatitis B Virus Pipeline Report
• Coverage: Global
• Key Chronic Hepatitis B Virus Companies: Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, 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, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, and others.
• Key Chronic Hepatitis B Virus Pipeline Therapies: Pradefovir, DA 2802, VIR-2218, AB-729, Selgantolimod, ATI-2173, ASC42, Hepalatide, QL-007, Antroquinonol, HEC121120, APG-1387, GSK3228836, JNJ-73763989, JNJ-56136379, Vonafexor, T101, BRII-179, aVTP-300, PA1010, P1101, NCO-48, HRS5091, EDP-514, CKD-388, LP-128, VNRX 9945, ZM-H1505R, ISA104, RG6346, HepTcell, RO7049389, RO7020531, and others.

Dive deep into rich insights for drugs used for chronic hepatitis B virus treatment; visit @ https://www.delveinsight.com/report-store/chronic-hepatitis-b-virus-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Chronic Hepatitis B Virus Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Chronic Hepatitis B Virus Pipeline Therapeutics
6. Chronic Hepatitis B Virus Pipeline: Late-Stage Products (Phase III)
7. Chronic Hepatitis B Virus Pipeline: Mid-Stage Products (Phase II)
8. Chronic Hepatitis B Virus Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.