Overcoming Barriers in Hepatitis B Drug Development: Customized Pilot Models Accelerate Preclinical Evaluation

01. Service Overview

Jennio provides customized HBV model construction services that stably simulate the pathological state of persistent HBV infection in vivo. These models are applicable to anti-HBV drug screening and preclinical efficacy evaluation, delivering precise and reliable integrated technical support for anti-hepatitis B drug research and development (R&D), and supporting clients to accelerate the R&D progress of innovative antiviral drugs.

02. Core Characteristics of the Model

• Short modeling cycle: A stable chronic HBV infection state can be established within 4–8 weeks.
• No reliance on transgenic animals: Convenient modeling with wide applicability.
• Highly mimics the pathological features of persistent HBV infection in humans.
• Excellent batch consistency and outstanding experimental repeatability.

03. Technology Platform and Advantages

Technology Platform

• A stable HBV model building system: AAV virus infection can be accurately predicted with an infection success rate of >90%.
• Fake virus packaging platform: Supports safety research on high-risk channels such as SARS-CoV-2 (BSL-2 certified).

Infrastructure

• SPF-grade animal facility + ABSL-2 laboratory: capable of conducting high-risk research, equipped with in vivo imaging systems, various hematological testing instruments (for detecting multiple viral monitoring indicators), ventilators and other equipment to support real-time treatment.
• Titer detection: High viral titers are used to ensure model stability.

Differentiation advantages

• Comprehensive coverage: A platform that supports full-chain assessment of bacteria, viruses, and fungi.
• Clinical relevance: The effectiveness of this model has been validated by a variety of detection methods, including histopathology (HE staining), biochemical indicators, and virological indicators.

04. Quality Control and Compliance

• Certifications: SPF animal facility certification, laboratory animal use permit.
• Quality control measures: double-blind data review, third-party cross-validation (e.g., comparing HBsAg detection with commercial kits).
• Compliance standards: Adhere to FDA/EMA guidelines for anti-infective drugs; data is traceable to original records.

05. Service Process

• Communication is required: Customize solutions based on the target type, the challenging infection site, and assessment metrics.
• Model execution and monitoring: Real-time sharing of model build details (e.g., DAI score, monthly burden).
• Data delivery (7-14 days): Provide GLP-compliant reports, including raw data, statistical analysis, and pathological slides.

06. Case Studies

HBV Model Efficacy Evaluation Services

The rAAV-HBV mouse model is adopted. Drug intervention is implemented after 6 weeks of stable model induction to assess the anti-HBV efficacy of test articles in each dose group. Meanwhile, entecavir (ETV), a classic marketed nucleoside analog positive control drug, is utilized for parallel efficacy comparison. Distinct anti-HBV activity and a favorable dose-effect relationship of the test article can be observed.

Detection Indicators

Comprehensive detection and evaluation can be performed simultaneously on serological virological indicators, hepatic viral nucleic acid and protein indicators, as well as indicators related to the overall safety of animals.

07. Comprehensive Advantages

• Standardized construction process: Strictly complies with the universal construction paradigm of the rAAV-HBV mouse model to ensure stable and controllable experiments.
• One-stop full-process service: Covers model construction, dosing regimen design, sample detection and statistical analysis.
• Professional positive control setup: Clinical first-line drugs such as entecavir and tenofovir can be selected for simultaneous control to objectively evaluate the efficacy of test articles.
• Compliant data management: Implemented in accordance with non-clinical research guidelines of NMPA and ICH, supporting project initiation, internal assessment and subsequent IND compliance.
• Full lifecycle support: From early screening to IND application treatment data packages.
• Efficient delivery: The delivery cycle for standard models is 30% faster than the industry average.
• Resource integration: It has a supply library of more than 1,000 varieties, covering a wide range of varieties and special imported varieties, which can quickly meet the research needs of specific varieties.

08. Application Scenarios

1. Preclinical in vivo screening and preliminary efficacy evaluation of innovative anti-HBV small-molecule compounds and candidate drugs.
2. Efficacy comparison and dosing optimization of nucleoside and nucleotide derivative candidate drugs.
3. In vivo efficacy evaluation of novel anti-HBV candidate drugs such as small nucleic acids and peptides.
4. In vivo antiviral effect verification of novel delivery vectors and formulations for hepatitis B.
5. Comprehensive assessment of the efficacy and safety of candidate drugs, providing data support for project initiation, regimen optimization and subsequent compliant non-clinical studies.

09. Clientele Served

We provide professional HBV model construction and efficacy evaluation technical services for biopharmaceutical enterprises, biotechnology companies, new drug R&D institutions and vaccine R&D-related enterprises engaged in the R&D of innovative anti-hepatitis B drugs and formulations.

In addition to antiviral drug efficacy evaluation, we also provide supporting technical services for hepatitis B mRNA vaccine R&D, launching hepatitis B mRNA vaccine animal model, ELISPOT T-cell detection services, covering the entire process of vaccine immunogenicity evaluation.

Customized immunized animal models for hepatitis B mRNA vaccines can be constructed to optimize immunization regimens and systematically evaluate immunogenicity. The ELISPOT technique is used to quantitatively detect the intensity of antigen-specific T-cell immune response, evaluating the ability of vaccines to activate the body’s specific cellular immunity. We provide full-process support from animal immunization, sample processing to detection analysis and result summary, which is suitable for immunogenicity screening, formulation optimization and preliminary efficacy evaluation of hepatitis B mRNA vaccines and therapeutic vaccines.

10. Laboratory Highlights

This Class 10,000 clean animal facility can house high-risk animals and has a daily sample processing capacity of over 100.

This isolation platform ensures the sterility of viral preparations and meets GMP standards.

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13. Contact Us

Inquire now:

• 3691125803@qq.com
• Telephone: +86 18802035152
• Online Forms: Get Free Customized Solutions

Resource download:

• Anti-infection model technology PDF
• GLP-compliant experimental procedure manual