Hepatitis B Virus Clinical Trials and Research: EMA, PMDA, FDA Approval, Mechanism of Action, ROA, NDA, IND, and Company

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DelveInsight's "Hepatitis B Virus (HBV) Infection Pipeline Insights" report provides a comprehensive overview of over 80 companies and 90+ pipeline drugs in the Hepatitis B Virus (HBV) Infection pipeline landscape. It provides detailed insights into the HBV pipeline drug

 

 

Stay ahead in the competitive pharmaceutical industry with in-depth insights into the Hepatitis B pipeline. See the latest advancements, the leading Hepatitis B companies driving innovation, and the most promising new drugs shaping the future of treatment. Download our comprehensive report now to explore the clinical-stage developments and strategic collaborations that are transforming the industry. @Hepatitis B Pipeline Outlook Report

Key Takeaways from the Hepatitis B Virus Pipeline Market

  • March 2025: Shanghai-based Yoltek Therapeutics announces promising results from the ongoing investigator-initiated clinical trial of YOLT-203 for patients with primary hyperoxaluria type 1 (PH1).

  • DelveInsight's Hepatitis B Virus pipeline report highlights a robust landscape, with over 80 active players developing over 90 pipeline treatments for Hepatitis B Virus.

  • Major companies in the Hepatitis B virus include:
    Vir Biotechnology, Arbutus Biopharma, Nucorion Pharmaceuticals, Xian Xintong Pharmaceutical Research, Dong-A ST Co. Ltd., Gilead Sciences, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Zhejiang Palo Alto Pharmaceutical, Pharma Essentia, Jiangsu Hengrui Pharmaceutical, Enanta Pharmaceutical, Zhongkundan Pharmaceutical, Guangzhou Luxeon Pharmaceutical, Zhimeng Biopharma, Dicerna Pharmaceutical, Altimmune, Viravax, Aligos Therapeutics, GC Biopharma, Immunocore, Huahui Health, Prism Pharma, Hepion Pharmaceutical, Hepatera, Virion Therapeutics, and others.

  • Promising Hepatitis B virus treatments include: tenofovir disoproxil fumarate, HBVAXPRO 5µg, pegylated interferon alfacon-2, bepirovirsen, daproxiran/tomurigisiran dose level 1, and many more.

Uncover Hepatitis B Virus groundbreaking developments in the drug pipeline in our latest report. Get exclusive insights into Hepatitis B Virus clinical trials, regulatory updates, and emerging medicines across multiple therapeutic areas. Learn how leading Hepatitis B Virus companies are positioning themselves for success in the evolving pharmaceutical market. Access the full report now!" @Evaluation of clinical trials for hepatitis B virus

New Drug Profile for Hepatitis B Virus

Bepirovirsen – GSK

Bepirovirsen is an investigational antisense oligonucleotide (ASO) designed to specifically recognize HBV RNA, prevent replication, and reduce viral antigens (proteins) that maintain chronic infection. ASO recruits liver enzymes that degrade viral RNA, leading to reduced infectivity of HBV DNA and antigen levels in the bloodstream. Bepirovirsen also stimulates an immune response via Toll-like receptor 8 (TLR8), potentially allowing for long-term viral clearance.

VIR-2218 - for biotechnology

VIR-2218 is a subcutaneously administered HBV-targeting siRNA with potential immune stimulatory and antiviral activity. Leveraging Enhanced Stabilization Chemistry Plus (ESC+) technology, it provides increased stability and minimizes off-target activity. Currently in Phase II trials, VIR-2218 is the first siRNA from Vir Biotechnology in partnership with Alnylam Pharmaceuticals to participate in clinical trials.

AB-729 - Arbutus Biopharma

AB-729 is an RNA interference (RNAi) therapy designed to reduce all HBV viral antigens, including Hepatitis B surface antigen (HBsAg), which is key to restoring an immune response. Using N-acetylgalactosamine (GalNAc) conjugation technology, AB-729 targets liver cells. It is currently being tested in a Phase IIa trial in combination with nucleoside analog therapy and Peg-IFNα-2a in chronic HBV patients.

AHB-137 - Osper Biopharma

AHB-137 is designed as a non-binding antisense oligonucleotide (ASO) as a potential backbone for the functional cure of chronic hepatitis B (CHB). In June 2023, the China Center for Drug Evaluation (CDE) approved it for the Investigational New Drug (IND) application. With high antiviral potency, good pharmacokinetics, and a strong safety profile, AHB-137 is currently in Phase I trials.

Hepatitis B Virus Pipeline Insights

The report provides:

  • Detailed insights into companies developing HBV treatments.

  • Segment treatment candidates into early, mid, and late stages of development.

  • HBV companies evaluate active and inactive (dormant/discontinued) projects.

  • HBV drugs are classified as follows: stage of development, route of administration, target receptor, monotherapy/combination therapy, mechanism of action, and type of molecule.

  • Analyzing the collaborations, licensing agreements, and financial investments shaping the future of HBV drug development.

Explore the dynamic world of drug development with our latest Hepatitis B Virus Pipeline Insights report. From early-stage research to late-stage Hepatitis B Virus clinical trials, our analysis covers leading Hepatitis B Virus companies, innovative treatment approaches, and the next wave of novel medicines. Don't miss out! Download now to stay up to date. @Hepatitis B Virus Treatment

Hepatitis B virus companies

Vir Biotechnology, Arbutus Biopharma, Nucorion Pharmaceuticals, Xian Xintong Pharmaceutical Research, Dong-A ST Co. Ltd., Gilead Sciences, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Zhejiang Palo Alto Pharmaceutical, Pharma Essentia, Jiangsu Hengrui Pharmaceutical, Enanta Pharmaceutical, Zhongkundang Pharmaceutical, Guangzhou Luxeon Pharmaceutical, Zhimeng Biopharma, Dicerna Pharmaceutical, Altimmune, Viravax, Aligos Therapeutics, GC Biopharma, Immunocore, Huahui Health, Prism Pharma, Hepion Pharmaceutical, Hepatera, Virion Therapeutics, and many more!

Evaluation of Hepatitis B Virus Therapy by Route of Administration

  • Oral

  • Intravenous

  • Subcutaneous

  • Parenteral

  • Hot Topic

Treatment evaluation of hepatitis B virus by molecular type

  • Recombinant fusion proteins

  • Low molecular weight

  • Monoclonal antibodies

  • peptide

  • polymer

  • Gene Therapy

The future of healthcare is rapidly evolving! Get detailed insights into ongoing Hepatitis B Virus clinical trials, leading companies driving innovation, and the most promising new drugs in the pipeline. Stay up to date with the latest Hepatitis B Virus pipeline insights. Download the report to take a closer look at the next generation of treatments. @Hepatitis B Virus Market Drivers, Barriers, and Future Outlook

 

Hepatitis B Virus Pipeline Market Scope

  • Scope – Global

  • Hepatitis B Virus Company -Vir Biotechnology, Arbutus Biopharma, Nucorion Pharmaceuticals, Xian Xintong Pharmaceutical Research, Dong-A ST Co. Ltd., Gilead Sciences, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Zhejiang Palo Alto Pharmaceutical, Pharma Essentia, Jiangsu Hengrui Pharmaceutical, Enanta Pharmaceutical, Zhongkundan Pharmaceutical, Guangzhou Lupeng Pharmaceutical, Zhimeng Biopharma, Dicerna Pharmaceutical, Altimune, Virabax, Aligos Therapeutics, GC Biopharma, Immunocore, Huahui Health, Prism Pharma, Hepion Pharmaceutical, Hepatella, Virion TherapeuticsAnd more.

  • Hepatitis B Virus Treatment -Tenofovir disoproxil fumarate, HBVAXPRO 5µg, peginterferon alfacon-2, bepirovirsen, daprsiran/tomurigisiran dose level 1,others.

  • Hepatitis B Virus Treatment Evaluation by Product Type: Mono, Combination, and Mono/Combination

  • Hepatitis B virus therapy evaluation by clinical phase: discovery, preclinical, phase I, phase II, phase III

Which new Hepatitis B Virus drugs will revolutionize the treatment landscape? Which Hepatitis B Virus companies are leading the way in drug discovery? Find the answers in our latest Hepatitis B Virus Pipeline Insights report, which offers in-depth coverage of clinical trials, regulatory developments, and upcoming breakthroughs. Download now and stay at the forefront of pharmaceutical innovation!" @New Hepatitis B Drugs and Companies

 

 

table of contents

  1. introduction

  2. executive summary

  3. Hepatitis B virus infection: an overview

  4. Pipeline Therapeutics

  5. Therapeutic evaluation

  6. Hepatitis B Virus Infection – A DelveInsight Analytical Perspective

  7. Late Stage Products (Phase III)

  8. Bepirovirsen: GSK

  9. Drug profile in detailed report…..

  10. Mid-stage products (Phase II)

  11. FOR 2218: For Biotechnology

  12. Drug profile in detailed report…..

  13. Early Stage Products (Phase I)

  14. AHB-137: Ausper Biopharmaceuticals

  15. Drug profile in detailed report…..

  16. Preclinical and Discovery Stage Products

  17. Drug name: Company name

  18. Drug profile in detailed report…..

  19. Inactive Products

  20. Hepatitis B Virus Infection Major Companies

  21. Key products for Hepatitis B virus infection

  22. Hepatitis B virus infection – an unmet need

  23. Hepatitis B Virus Infection-Market Drivers and Barriers

  24. Hepatitis B virus infection - prospects and conclusions

  25. Hepatitis B virus infection analyst's view

  26. Hepatitis B Virus Infection Major Companies

  27. appendix

 

About Us

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