Hepatitis B Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Hepatitis B Virus (HBV) Infection Pipeline Insight, 2025" report provides comprehensive insights about 80+ companies and 90+ pipeline drugs in Hepatitis B Virus (HBV) Infection pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Explore our comprehensive Hepatitis B Pipeline Pipeline Report to stay informed about the latest advancements. Download copy now @ Hepatitis B Pipeline Pipeline Outlook- https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Key Takeaways from the Hepatitis B Pipeline Pipeline Report
• In March 2025, GlaxoSmithKline announced a study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from other approved adjuvant systems and from an aluminum-based adjuvant.
• In January 2025, Janssen Research & Development LLC announced a study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.
• DelveInsight's Hepatitis B pipeline report depicts a robust space with 80+ active players working to develop 90+ pipeline therapies for Hepatitis B treatment.
• The leading Hepatitis B Companies such as 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 Pharmaceuticals, PharmaEssentia, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, Zhimeng Biopharma, Dicerna Pharmaceuticals, Altimmune, Viravaxx, Aligos Therapeutics, GC Biopharma, Immunocore, Huahui Health, PRISM Pharma, Hepion Pharmaceuticals, Hepatera, Virion Therapeutics and others.
• Promising Hepatitis B Pipeline Therapies such as SB 9200, Tenofovir, Entecavir, GSK3965193, Bepirovirsen, Ledipasvir 90 MG, Sofosbuvir 400 MG Oral Tablet [Harvoni], EngerixTM-B and others.

Discover how the Hepatitis B treatment paradigm is evolving. Access DelveInsight's in-depth G Hepatitis B Pipeline Analysis for a closer look at promising breakthroughs @ Hepatitis B Clinical Trials and Studies- https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Hepatitis B Emerging Drugs Profile

• Bepirovirsen: GSK
Bepirovirsen is an investigational antisense oligonucleotide (ASO) designed to specifically recognise the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens (proteins) which facilitate chronicity of the disease by helping to avoid clearance by the immune system. The ASO recruits the liver's own enzymes to eliminate the RNA by digesting it to an inactive form. The subsequent reduction in the levels of the RNA results in a decrease in both the virus and the production of viral antigen (HBsAg) by the hepatocytes, which can be measured by a drop in the HBV DNA and antigen levels in the circulating blood. Bepirovirsen has an additional property of stimulating immune responses via Toll-like receptor 8 (TLR8) which may help the immune system to achieve durable clearance of the virus from circulating blood.

Bepirovirsen (previously known as 'ISIS 505358 or IONIS-HBVRX') was discovered by and jointly developed with Ionis Pharmaceuticals. Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019. Currently, the drug is in the Phase III stage of its development for the treatment of Hepatitis B Virus Infection.

• VIR 2218: Vir Biotechnology
VIR-2218 is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. VIR-2218 is the first asset in the company's collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. Currently, the drug is in the Phase II stage of its development for the treatment of Hepatitis B Virus Infection.

• AB 729: Arbutus Biopharma
AB-729 is a subcutaneously-delivered RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient's immune system to respond to the virus. AB-729 targets hepatocytes using the novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology. AB-729 is currently being evaluated in a Phase IIa randomized, open-label, proof-of-concept clinical trial in combination with ongoing standard-of-care nucleos(t)ide analog therapy and short courses of Peg-IFNα-2a in 40 patients with chronic HBV infection.

• AHB-137: Ausper Biopharma
AHB-137 is an unconjugated antisense oligonucleotide (ASO) with the potential to be a backbone for the functional cure of CHB. In June 2023, AusperBio announced that the Center for Drug Evaluation (CDE) of China has approved the Investigational New Drug (IND) application of AHB-137 to treat chronic hepatitis B (CHB) aiming for functional cure. AHB-137's highly potent antiviral activity in preclinical studies, along with its favorable pharmacokinetics and safety profile, garnered significant attention and recognition. Currently, the drug is in the Phase I stage of its development for the treatment of Hepatitis B Virus Infection.

The Hepatitis B Pipeline Report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Hepatitis B 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 Treatment.
• Hepatitis B Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Hepatitis B 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 market.

Get a detailed analysis of the latest innovations in the Hepatitis B pipeline. Explore DelveInsight's expert-driven report today! @ Hepatitis B Unmet Needs- https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Hepatitis B 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 Pharmaceuticals, PharmaEssentia, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, Zhimeng Biopharma, Dicerna Pharmaceuticals, Altimmune, Viravaxx, Aligos Therapeutics, GC Biopharma, Immunocore, Huahui Health, PRISM Pharma, Hepion Pharmaceuticals, Hepatera, Virion Therapeutics and others.

Hepatitis B Virus 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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Hepatitis B Products have been categorized under various Molecule types such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Download DelveInsight's latest report to gain strategic insights into upcoming Hepatitis B Therapies and key Hepatitis B Developments @ Hepatitis B Market Drivers and Barriers, and Future Perspectives- https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the Hepatitis B Pipeline Report
• Coverage- Global
• Hepatitis B 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 Pharmaceuticals, PharmaEssentia, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, Zhimeng Biopharma, Dicerna Pharmaceuticals, Altimmune, Viravaxx, Aligos Therapeutics, GC Biopharma, Immunocore, Huahui Health, PRISM Pharma, Hepion Pharmaceuticals, Hepatera, Virion Therapeutics and others.
• Hepatitis B Pipeline Therapies- SB 9200, Tenofovir, Entecavir, GSK3965193, Bepirovirsen, Ledipasvir 90 MG, Sofosbuvir 400 MG Oral Tablet [Harvoni], EngerixTM-B and others.
• Hepatitis B Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Hepatitis B Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in Hepatitis B drug development? Find out in DelveInsight's exclusive Hepatitis B Pipeline Report-access it now! @ Hepatitis B Emerging Drugs and Major Companies- https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Content
1. Introduction
2. Executive Summary
3. Hepatitis B Virus Infection: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Hepatitis B Virus Infection- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Bepirovirsen: GSK
9. Drug profiles in the detailed report.....
10. Mid Stage Products (Phase II)
11. VIR 2218: Vir Biotechnology
12. Drug profiles in the detailed report.....
13. Early Stage Products (Phase I)
14. AHB-137: Ausper Biopharma
15. Drug profiles in the detailed report.....
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report.....
19. Inactive Products
20. Hepatitis B Virus Infection Key Companies
21. Hepatitis B Virus Infection Key Products
22. Hepatitis B Virus Infection- Unmet Needs
23. Hepatitis B Virus Infection- Market Drivers and Barriers
24. Hepatitis B Virus Infection- Future Perspectives and Conclusion
25. Hepatitis B Virus Infection Analyst Views
26. Hepatitis B Virus Infection Key Companies
27. Appendix

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