Hepatitis B Virus Infection - Pipeline Insight, 2024

This “Hepatitis B Virus Infection - Pipeline Insight, 2024” report provides comprehensive insights about 80+ companies and 90+ pipeline drugs in Hepatitis B Virus 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.

Geography Covered

• Global coverage

Hepatitis B Virus Infection: Understanding

Hepatitis B Virus Infection: 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. The incubation period of HBV infection is typically between 30 and 180 days, and while recovery is common in immunocompetent patients, a small percentage can progress to a chronic state, serologically defined as the presence of HBsAg for greater than six months. HBsAg is transmitted via blood contact or body secretions, and the risk of acquiring hepatitis B is considerably higher in individuals with close contact with HBsAg-positive patients.

The pathogenesis of liver disease in HBV infection is mainly immune-mediated, and in some circumstances, HBV can cause direct cytotoxic injury to the liver. HBsAg and other nucleocapsid proteins that are present on cell membranes promote T cells-induced cellular lysis of HBV-infected cells. Cytotoxic T cell response to HBV-infected hepatocytes is relatively ineffective; a significant majority of HBV DNA is cleared from the hepatic system prior to maximal T cell infiltration, suggesting that the immune response is likely more robust in the early stages of infection. The immune response may not be the sole etiology behind hepatic injury in hepatitis B patients. Hepatitis B-associated injury is also seen in post-liver transplant patients with hepatitis B that are on immunosuppressant therapy. The histological pattern that follows from this infection is termed fibrosing cholestatic hepatitis and is thought to be associated with an overwhelming exposure to HBsAg. This lends credence to the idea that hepatitis B may possess pathogenicity regardless of the immune system’s response.

Initial symptoms are nonspecific and may include anorexia, nausea, vomiting, abdominal pain, and jaundice. In cases of severe liver damage, patients can develop jaundice, hepatic encephalopathy, ascites, and gastrointestinal bleeding secondary to esophageal varices, coagulopathy, or infections. Diagnosis is based on serologic blood tests in patients with suspected signs and symptoms and associated risk factors for viral hepatitis.

The diagnosis of Hepatitis B is based on proper history taking, physical examination, laboratory works, and imaging. The diagnosis of hepatitis B relies on the appropriate history/physical and evaluation of serum or viral biomarkers. Viral serology of hepatitis B is usually detectable 1-12 weeks after initial infection with the primary viral marker being hepatitis B surface antigen (HBsAg). The presence of HBsAg rarely persists beyond 6 months after infection and typically precedes detectable quantities of the corresponding antibody to surface antigen (Anti-HBsAg). The period of time between the disappearance of HBsAg and the appearance of Anti-HBsAg is termed “the window period” or “serological gap.” During the window period, other viral serology could also be undetectable. HBsAg is the first virological marker to be detected thanks to its exposure on the viral surface and is indicative of an acute infection. All patients with chronic hepatitis B should be treated with antiviral medications and regularly monitored for efficient treatment. The current treatment is based on nucleostide analogs and pegylated interferons that save lives by decreasing liver cancer death, liver transplant, slow or reverse the progression of liver disease as well as the virus infectivity.

Hepatitis B Virus Infection- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hepatitis B Virus Infection pipeline landscape is provided which includes the disease overview and Hepatitis B Virus Infection treatment guidelines. The assessment part of the report embraces, in depth Hepatitis B Virus Infection commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Hepatitis B Virus Infection collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Hepatitis B Virus Infection R&D. The therapies under development are focused on novel approaches to treat/improve Hepatitis B Virus Infection.

Hepatitis B Virus Infection Emerging Drugs Chapters

This segment of the Hepatitis B Virus Infection report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Hepatitis B Virus Infection Emerging Drugs

Bepirovirsen: GSKBepirovirsen 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 si RNA 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 BVirusInfection.

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-IFNa-2a in 40 patients with chronic HBVinfection.

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 VirusInfection.

Hepatitis B Virus Infection: Therapeutic Assessment

This segment of the report provides insights about the different Hepatitis B Virus Infection drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Hepatitis B Virus Infection

• There are approx. 80+ key companies which are developing the therapies for Hepatitis B Virus Infection. The companies which have their Hepatitis B Virus Infection drug candidates in the most advanced stage, i.e. phase III include, GSK.

Phases

This report covers around 90+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

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

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Hepatitis B Virus Infection: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hepatitis B Virus Infection therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Hepatitis B Virus Infection drugs.

Hepatitis B Virus Infection Report Insights

• Hepatitis B Virus Infection Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Hepatitis B Virus Infection Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Hepatitis B Virus Infection drugs?
• How many Hepatitis B Virus Infection drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hepatitis B Virus Infection?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hepatitis B Virus Infection therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hepatitis B Virus Infection and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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
• Pharma Essentia
• 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

Key Products

• VIR 2218
• AB 729
• NCO-48
• Pradefovir
• DA 2802
• Selgantolimod
• ATI-2173
• ASC42
• Hepalatide
• Antroquinonol
• HEC121120
• APG-1387
• GSK3228836
• JNJ-73763989
• JNJ-56136379
• T101
• BRII-179
• PA1010
• P1101
• HRS5091, EDP-514, CKD-388, LP-128, ZM-H1505R, ISA104, RG6346, Hep Tcell,VVX001,
• ALG-000184
• GC5103
• IMC-I109V
• Myrcludex B
• HH-003
• CRV431
• PRI-724
• VRON-0200

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