Chronic hepatitis B virus (HBV) is a long-term liver infection caused by the hepatitis B virus, leading to severe complications such as cirrhosis and liver cancer. It accounts for around 257 million cases globally (3.2%), with 1.5 million new cases annually. Better therapies and the growing focus on functional cures are driving advancements in disease therapeutics. The chronic hepatitis B virus pipeline analysis by the publisher focuses on various treatment options for this disease. Recent developments include RNA-based therapies, immune modulators, and gene editing techniques. Increasing research, improved diagnostics, and innovative treatments are expected to fuel the growth of chronic hepatitis B virus drug candidates in the coming years.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to chronic hepatitis B virus therapeutics.
Chronic Hepatitis B is managed with antiviral medications that suppress viral replication and reduce liver damage. Nucleos(t)ide analogues like entecavir and tenofovir are first-line treatments, while pegylated interferon is used in select cases. Emerging therapies aim to achieve functional cure by targeting HBV replication and immune response. Regular monitoring and liver health management remain crucial for disease control and prevention of complications. In February 2024, GSK announced that the US FDA has granted fast track designation for Bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B, expediting its development as a potential functional cure for millions worldwide.
In the chronic hepatitis B virus pipeline, most candidates are in Phase II with 41.84% of the projects, followed by 27.55% in Phase I and 19.39% in Phase IV. Additionally, 8.16% are in Phase III and 3.06% are in Early Phase I, demonstrating a broad spectrum of development stages and diverse progress toward potential treatments.
Capsid assembly modulators (CAMs) are emerging as promising agents in the chronic hepatitis B virus pipeline. For example, HAP18, a small molecule assembly agonist, disrupts the HBV core protein dimer’s hydrogen bonding while stabilizing capsids. This dual action results in empty, defective capsids and impedes viral genome release, reducing the formation of new infectious particles.
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Report Coverage
The Chronic Hepatitis B Virus Pipeline Insight Report by the publisher gives comprehensive insights into chronic hepatitis B virus therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for chronic hepatitis B virus therapeutics. The chronic hepatitis B virus therapeutics report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The chronic hepatitis B virus therapeutics pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with chronic hepatitis B virus therapeutics treatment guidelines to ensure optimal care practices.The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to chronic hepatitis B virus therapeutics.
Chronic Hepatitis B Virus Pipeline Outlook
Chronic hepatitis B virus (cHBV) is a long-term liver infection caused by the hepatitis B virus (HBV). It occurs when the immune system fails to clear the virus after acute infection, leading to persistent viral replication. Transmission happens through infected blood, unprotected sex, or from mother to child at birth, increasing the risk of liver damage, cirrhosis, and liver cancer.Chronic Hepatitis B is managed with antiviral medications that suppress viral replication and reduce liver damage. Nucleos(t)ide analogues like entecavir and tenofovir are first-line treatments, while pegylated interferon is used in select cases. Emerging therapies aim to achieve functional cure by targeting HBV replication and immune response. Regular monitoring and liver health management remain crucial for disease control and prevention of complications. In February 2024, GSK announced that the US FDA has granted fast track designation for Bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B, expediting its development as a potential functional cure for millions worldwide.
Chronic Hepatitis B Virus Epidemiology
Hepatitis B continues to be a major global health challenge. In 2022, an estimated 257 million people were living with HBV worldwide, with approximately 1.5 million new cases reported annually. In the United States, chronic infections range between 880,000 and 1.89 million cases. The United Kingdom reports an estimated 268,000 cases, while Japan has nearly 1 million. India recorded the second-highest number of hepatitis B and C cases in 2022.Chronic Hepatitis B Virus - Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of chronic hepatitis B virus drug candidates based on several segmentations, including:By Phase
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
By Drug Class
- Small Molecules
- RNA-based Therapies
- Peptides
- Biologics
- Gene Editing Therapies
By Route of Administration
- Oral
- Parenteral
- Others
Chronic Hepatitis B Virus - Pipeline Assessment Segmentation, By Phases
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to analysis, phase II covers a major share of the total chronic hepatitis B virus clinical trials.In the chronic hepatitis B virus pipeline, most candidates are in Phase II with 41.84% of the projects, followed by 27.55% in Phase I and 19.39% in Phase IV. Additionally, 8.16% are in Phase III and 3.06% are in Early Phase I, demonstrating a broad spectrum of development stages and diverse progress toward potential treatments.
Chronic Hepatitis B Virus - Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the chronic hepatitis B virus pipeline analysis include small molecules, RNA-based therapies, peptides, biologics, and gene editing therapies. The chronic hepatitis B virus report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for chronic hepatitis B virus.Capsid assembly modulators (CAMs) are emerging as promising agents in the chronic hepatitis B virus pipeline. For example, HAP18, a small molecule assembly agonist, disrupts the HBV core protein dimer’s hydrogen bonding while stabilizing capsids. This dual action results in empty, defective capsids and impedes viral genome release, reducing the formation of new infectious particles.
Chronic Hepatitis B Virus Clinical Trials - Key Players
The report for the chronic hepatitis B virus pipeline analysis covers the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in chronic hepatitis B virus clinical trials:- GlaxoSmithKline
- Tune Therapeutics, Inc.
- Brii Biosciences Limited
- Vir Biotechnology, Inc.
- Assembly Biosciences
- Ascentage Pharma Group Inc.
- Vaxine Pty Ltd.
- Epigenic Therapeutics, Inc.
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Ausper Biopharma Co., Ltd.
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Chronic Hepatitis B Virus - Emerging Drugs Profile
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for chronic hepatitis B virus. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of chronic hepatitis B virus drug candidates.Drug: Bepirovirsen
Bepirovirsen, developed by GlaxoSmithKline, is an investigational antisense oligonucleotide (ASO) designed for the treatment of chronic hepatitis B (CHB). It works by targeting and degrading hepatitis B virus RNA, inhibiting viral DNA replication, reducing hepatitis B surface antigen (HBsAg) levels, and stimulating the immune response. The drug candidate is a part of a Phase III study, which aims to confirm its efficacy, safety, and durability in nucleos(t)ide analogue-treated patients.Drug: VIR
VIR-2218, VIR-3434, and PEG-IFNa are being evaluated in a Phase II study sponsored by Vir Biotechnology, Inc. The study aims to assess their safety, tolerability, and efficacy in chronic hepatitis B virus (HBV) infection. VIR-3434, a monoclonal antibody, targets HBV surface antigen (HBsAg), while VIR-2218, a small interfering RNA (siRNA), reduces HBV replication.Drug: ABI-4334
ABI-4334 is undergoing clinical development to target chronic hepatitis B virus (cHBV). In this Phase I study, sponsored by Assembly Biosciences, researchers are evaluating its safety, pharmacokinetics, and antiviral activity. ABI-4334 disrupts HBV capsids in the cytoplasm, preventing viral entry into the nucleus and blocking the formation of covalently closed circular DNA (cccDNA), essential for HBV replication.Reasons To Buy This Report
The Chronic Hepatitis B Virus Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for chronic hepatitis B virus. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into chronic hepatitis B virus collaborations, regulatory environments, and potential growth opportunities.Key Questions Answered in the Chronic Hepatitis B Virus Pipeline Analysis Report
- Which companies/institutions are leading the chronic hepatitis B virus drug development?
- What is the efficacy and safety profile of chronic hepatitis B virus pipeline drugs?
- Which company is leading the chronic hepatitis B virus pipeline development activities?
- What is the current chronic hepatitis B virus commercial assessment?
- What are the opportunities and challenges present in the chronic hepatitis B virus pipeline landscape?
- What is the efficacy and safety profile of chronic hepatitis B virus pipeline drugs?
- Which company is conducting major trials for chronic hepatitis B virus drugs?
- Which companies/institutions are involved in chronic hepatitis B virus collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in chronic hepatitis B virus?
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Table of Contents
1 Preface
3 Overview of Chronic Hepatitis B Virus
4 Patient Profile: Chronic Hepatitis B Virus
5 Chronic Hepatitis B Virus: Epidemiology Snapshot
6 Chronic Hepatitis B Virus: Market Dynamics
7 Chronic Hepatitis B Virus: Key Facts Covered
8 Chronic Hepatitis B Virus, Drug Pipeline Assessment
9 Drug Pipeline Comparative Analysis
10 Chronic Hepatitis B Virus Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
11 Chronic Hepatitis B Virus Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
12 Chronic Hepatitis B Virus Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
13 Chronic Hepatitis B Virus Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
14 Chronic Hepatitis B Virus, Key Drug Pipeline Companies
