Chronic Hepatitis B Virus Pipeline 2025: MOA And ROA Insights, Clinical Trials Status, And Key Companies Involved By Delveinsight Ascletis Pharma, Shanghai HEP Pharma, Romark Lab, Qilu Pharma

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(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Chronic Hepatitis B Virus pipeline constitutes 50+ key companies continuously working towards developing 55+ Chronic Hepatitis B Virus treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

“Chronic Hepatitis B Virus Pipeline Insight, 2025 " report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Chronic Hepatitis B Virus Market.

The Chronic Hepatitis B Virus 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 Chronic Hepatitis B Virus Pipeline Report:

• Companies across the globe are diligently working toward developing novel Chronic Hepatitis B Virus treatment therapies with a considerable amount of success over the years.

• Chronic Hepatitis B Virus 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 Chronic Hepatitis B Virus treatment

• Emerging Chronic Hepatitis B Virus 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 Chronic Hepatitis B Virus market in the coming years.

• In June 2025, TherVacB, an innovative therapeutic vaccine for chronic hepatitis B developed by Helmholtz Munich in partnership with the German Center for Infection Research (DZIF), began its first clinical trial in patients. After a successful Phase Ia trial in healthy volunteers, which showed a favorable safety profile and induced the intended immune responses, the study has advanced to a multi-center Phase Ib/IIa trial, with the first patient enrolled in June 2025.

• In May 2025, interim data from a Phase 2b clinical trial showed that AHB-137, Ausperbio's investigational therapy, safely and effectively suppressed the hepatitis B virus (HBV) in individuals with chronic hepatitis B. These encouraging results, consistent with earlier findings from an ongoing Phase 1/2a trial (NCT06115993), were presented during a poster session at the annual European Association for the Study of the Liver Congress.

• In May 2025, Vir Biotechnology's combination therapy aimed at a“functional cure” for hepatitis B did not meet efficacy endpoints in a Phase II trial. Data from the 24-week mark of the ongoing MARCH Phase II study (NCT04856085) showed that only 17% (3/18) of patients receiving tobevibart and elebsiran alone, and 21% (3/14) of those receiving the combination with peginterferon, achieved undetectable hepatitis B surface antigen (HBsAg) among patients with baseline HBsAg <1,000 IU/mL. Functional cure was attained in just 11% and 15% of patients, respectively, for the two treatment regimens.

• In March 2025, Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical-stage gene editing company utilizing its ARCUS® platform to develop in vivo therapies for diseases with high unmet needs, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PBGENE-HBV. This lead program focuses on curing chronic hepatitis B by eliminating cccDNA, the main source of HBV replication, and inactivating integrated HBV DNA in liver cells. Precision is preparing U.S. trial sites for patient enrollment in the ELIMINATE-B trial, which addresses over one million people living with chronic hepatitis B in the U.S. The study is already enrolling patients in Moldova, Hong Kong, and New Zealand, with Phase 1 clinical activities soon to begin in the U.S. at the Liver Center, Massachusetts General Hospital.

• In February 2025, Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical-stage gene editing firm leveraging its ARCUS® platform to develop in vivo therapies for diseases with high unmet needs, has reported initial data from the first dosing of PBGENE-HBV in cohort 1 of the ELIMINATE-B trial, which represents the lowest dose group. The study aims to assess PBGENE-HBV across multiple escalating dose levels, with three administrations per level, in HBeAg-negative chronic Hepatitis B patients.

• In October 2024, Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical-stage gene editing company leveraging its proprietary ARCUS® platform to develop in vivo gene editing therapies for complex gene modifications, announced that it has received Clinical Trial Application (CTA) approval in Moldova for its lead candidate, PBGENE-HBV. PBGENE-HBV is Precision's exclusive in vivo gene editing program aimed at curing chronic hepatitis B by eliminating cccDNA, a key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in hepatocytes. The company has launched the Phase 1 clinical program and is preparing to begin patient dosing.

• In October 2024, Barinthus Biotherapeutics plc (NASDAQ: BRNS) , a clinical-stage biopharmaceutical company focused on developing innovative immunotherapeutic candidates to direct T cells in disease control, has announced the completion of enrollment for two clinical trials: HBV003, a Phase 2b trial of VTP-300 in adults with chronic hepatitis B (CHB), and PCA001, a Phase 1 trial of VTP-850 in men with rising prostate-specific antigen (PSA) following definitive local therapy for prostate cancer (i.e., biochemical recurrence).

Chronic Hepatitis B Virus Overview

Chronic Hepatitis B Virus (HBV) infection is a long-term, persistent infection caused by the hepatitis B virus. Hepatitis B is a virus that primarily affects the liver and can lead to both acute and chronic forms of hepatitis.

Get a Free Sample PDF Report to know more about Chronic Hepatitis B Virus Pipeline Therapeutic Assessment-

Emerging Chronic Hepatitis B Virus 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

Chronic Hepatitis B Virus Route of Administration

Chronic Hepatitis B Virus 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

Chronic Hepatitis B Virus Molecule Type

Chronic Hepatitis B Virus Products have been categorized under various Molecule types, such as

• Monoclonal Antibody

• Peptides

• Polymer

• Small molecule

• Gene therapy

Chronic Hepatitis B Virus Pipeline Therapeutics Assessment

• Chronic Hepatitis B Virus Assessment by Product Type

• Chronic Hepatitis B Virus By Stage and Product Type

• Chronic Hepatitis B Virus Assessment by Route of Administration

• Chronic Hepatitis B Virus By Stage and Route of Administration

• Chronic Hepatitis B Virus Assessment by Molecule Type

• Chronic Hepatitis B Virus by Stage and Molecule Type

DelveInsight's Chronic Hepatitis B Virus Report covers around 55+ 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 Chronic Hepatitis B Virus product details are provided in the report. Download the Chronic Hepatitis B Virus pipeline report to learn more about the emerging Chronic Hepatitis B Virus therapies

Some of the key companies in the Chronic Hepatitis B Virus Therapeutics Market include:

Key companies developing therapies for Chronic Hepatitis B Virus 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.

Chronic Hepatitis B Virus Pipeline Analysis:

The Chronic Hepatitis B Virus pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Chronic Hepatitis B Virus 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 Chronic Hepatitis B Virus Treatment.

• Chronic Hepatitis B Virus key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Chronic Hepatitis B Virus 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 Chronic Hepatitis B Virus 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 Chronic Hepatitis B Virus drugs and therapies

Chronic Hepatitis B Virus 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 Chronic Hepatitis B Virus Market.

Chronic Hepatitis B Virus Pipeline Market Barriers

• However, high cost of treatment, limited access to the diagnosis of hepatitis B and other factors are creating obstacles in the Chronic Hepatitis B Virus Market growth.

Scope of Chronic Hepatitis B Virus Pipeline Drug Insight

• Coverage: Global

• Key Chronic Hepatitis B Virus 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 Chronic Hepatitis B Virus 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

• Chronic Hepatitis B Virus Therapeutic Assessment: Chronic Hepatitis B Virus current marketed and Chronic Hepatitis B Virus emerging therapies

• Chronic Hepatitis B Virus Market Dynamics: Chronic Hepatitis B Virus market drivers and Chronic Hepatitis B Virus market barriers

Request for Sample PDF Report for Chronic Hepatitis B Virus Pipeline Assessment and clinical trials

Table of Contents

1. Chronic Hepatitis B Virus Report Introduction

2. Chronic Hepatitis B Virus Executive Summary

3. Chronic Hepatitis B Virus Overview

4. Chronic Hepatitis B Virus- Analytical Perspective In-depth Commercial Assessment

5. Chronic Hepatitis B Virus Pipeline Therapeutics

6. Chronic Hepatitis B Virus Late Stage Products (Phase II/III)

7. Chronic Hepatitis B Virus Mid Stage Products (Phase II)

8. Chronic Hepatitis B Virus Early Stage Products (Phase I)

9. Chronic Hepatitis B Virus Preclinical Stage Products

10. Chronic Hepatitis B Virus Therapeutics Assessment

11. Chronic Hepatitis B Virus Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Chronic Hepatitis B Virus Key Companies

14. Chronic Hepatitis B Virus Key Products

15. Chronic Hepatitis B Virus Unmet Needs

16 . Chronic Hepatitis B Virus Market Drivers and Barriers

17. Chronic Hepatitis B Virus Future Perspectives and Conclusion

18. Chronic Hepatitis B Virus 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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