Press release
Hepatitis B Virus Infection Clinical Trial Pipeline Accelerates as 80+ Pharma Companies Rigorously Develop Drugs for Market Entry | DelveInsight
Discover the latest drugs and treatment options in the Hepatitis B Virus Infection Pipeline. Dive into DelveInsight's comprehensive report today! @ Hepatitis B Virus Infection Pipeline Outlook [https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Key Takeaways from the Hepatitis B Virus Infection Pipeline Report
* On December 17, 2025 - The U.S. Centers for Disease Control and Prevention (CDC) officially withdrew its long-standing recommendation for universal hepatitis B vaccination at birth. Under the updated guidance, parents of infants born to mothers who test negative for hepatitis B are now encouraged to consult with a healthcare provider before deciding whether to administer the first vaccine dose immediately after birth. The policy shift, proposed by an advisory committee, was formally approved on Tuesday by Acting CDC Director Jim O'Neill, thereby establishing it as official CDC guidance.
* On December 15, 2025- GlaxoSmithKline announced a study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48.
* On December 01, 2025, Gilead Sciences initiated a clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.
* DelveInsight's Hepatitis B Virus Infection pipeline report depicts a robust space with 80+ active players working to develop 90+ pipeline therapies for Hepatitis B Virus Infection treatment.
* The leading Hepatitis B Virus Infection 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 Virus Infection Pipeline Therapies such as Peginterferon Alfacon-2, Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni], Entecavir, Tenofovir disoproxil fumarate (TDF), Bepirovirsen and others.
Stay ahead with the most recent pipeline outlook for Hepatitis B Virus Infection. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Hepatitis B Virus Infection Treatment Drugs [https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
The Hepatitis B Virus Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Hepatitis B Virus Pipeline Report also highlights the unmet needs with respect to the Hepatitis B Virus.
Hepatitis B Virus Overview
Hepatitis B viral infection is a serious global healthcare problem. It is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). Hepatitis B virus is transmitted via percutaneous inoculation or through mucosal exposure with infectious bodily fluids. Oral-fecal transmission is possible but considerably rare.
Hepatitis B Virus Infection 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-IFN-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.
Explore groundbreaking therapies and clinical trials in the Hepatitis B Virus Infection Pipeline. Access DelveInsight's detailed report now! @ New Hepatitis B Virus Infection Drugs [https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Hepatitis B Virus Infection 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.
The Hepatitis B Virus Infection Pipeline Report Provides Insights into
* The report provides detailed insights about companies that are developing therapies for the treatment of Hepatitis B Virus 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 Infection Treatment.
* Hepatitis B Virus Infection Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Hepatitis B Virus 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 Infection market
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 Virus Infection Products have been categorized under various Molecule types such as
* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy
Unveil the future of Hepatitis B Virus Infection Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Hepatitis B Virus Infection Market Drivers and Barriers [https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Scope of the Hepatitis B Virus Infection Pipeline Report
* Coverage- Global
* Hepatitis B Virus Infection 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 Therapies- Peginterferon Alfacon-2, Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni], Entecavir, Tenofovir disoproxil fumarate (TDF), Bepirovirsen and others.
* Hepatitis B Virus Infection Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Hepatitis B Virus Infection Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Get the latest on Hepatitis B Virus Infection Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Hepatitis B Virus Infection Companies, Key Products and Unmet Needs [https://www.delveinsight.com/sample-request/hepatitis-b-virus-hbv-infection-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]
Table of Content
* Introduction
* Executive Summary
* Hepatitis B Virus Infection: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Hepatitis B Virus Infection- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Bepirovirsen: GSK
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* VIR 2218: Vir Biotechnology
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* AHB-137: Ausper Biopharma
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Hepatitis B Virus Infection Key Companies
* Hepatitis B Virus Infection Key Products
* Hepatitis B Virus Infection- Unmet Needs
* Hepatitis B Virus Infection- Market Drivers and Barriers
* Hepatitis B Virus Infection- Future Perspectives and Conclusion
* Hepatitis B Virus Infection Analyst Views
* Hepatitis B Virus Infection Key Companies
* Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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