BOSTON and SUZHOU, China, June 3, 2026 /PRNewswire/ — HkeyBio announced today the launch of preclinical disease model platforms covering Autoimmune Hepatitis (AIH), Primary Biliary Cholangitis (PBC), and IgA Nephropathy (IgAN). This platform integrates standardized rodent models with continuously developing non-human primate (NHP) research capabilities. It aims to support global innovative drug R&D institutions in conducting efficacy evaluation, mechanistic studies, biomarker development, and cross-species translational research.

As the treatment field of autoimmune diseases continues to be a critical direction for global pharmaceutical innovation, R&D institutions are seeing an increasing demand for disease models with clinical relevance and translational predictive capabilities. Particularly in the fields of autoimmune liver diseases and immune-mediated nephropathies, disease heterogeneity, long-term disease courses, and complex immune mechanisms pose significant challenges to preclinical research.

News Summary

• Launches standardized preclinical disease model platforms for AIH, PBC, and IgAN.
• Supports efficacy evaluation, mechanistic studies, and biomarker development.
• Builds a research system covering both rodents and non-human primates (NHP).
• Focuses on translational medicine research in the fields of autoimmune and inflammatory diseases.
• Supports the translation of innovative drugs from the drug discovery phase to the IND application phase.

Global Autoimmune Disease R&D Enters the Era of Translational Efficiency Competition

Over the past decade, global R&D in autoimmune diseases has continued to grow. In addition to the traditional TNF-α, IL-17, and IL-23 pathways, new mechanisms such as APRIL, BAFF, the complement system, FcRn, TYK2, and the reconstruction of immune tolerance are becoming R&D hotspots.

An increasing number of R&D projects are beginning to adopt the “One Molecule, Multiple Indications” strategy. This covers diseases of multiple organ systems, including liver, kidney, intestinal, and skin tissues, through shared immune mechanisms.

At the same time, industry research indicates that a significant translational gap still exists between preclinical research results and clinical benefits. How to improve the translational predictive capability of drug candidates is becoming a crucial subject in innovative drug R&D.

In recent years, the FDA, EMA, and ICH have continuously encouraged the improvement of clinical predictive capabilities and R&D efficiency through biomarkers, pharmacologically relevant models, and translational research strategies. They encourage the development of research models that can better reflect human disease characteristics, thereby increasing drug R&D efficiency and clinical success rates.

Management Perspective

The management of HkeyBio stated:

“As autoimmune disease drug R&D gradually shifts from single indications toward cross-organ immune mechanism research, the demand from R&D teams for high-translational-value disease models continues to rise. More and more innovative therapies are simultaneously focusing on the interactions among the liver, kidneys, intestines, and the systemic immune system. Traditional single-disease models can no longer fully satisfy the needs of complex mechanism research and clinical translation.

We hope that by building a research platform covering both rodents and non-human primates, we can provide global partners with more clinically relevant efficacy evaluations and translational medicine support. This will help R&D teams identify the potential and risks of drug candidates earlier in the preclinical stage, improve R&D decision-making efficiency, and propel innovative therapies into clinical development more efficiently.”

AIH: The Continuously Growing Burden of Autoimmune Liver Disease

Autoimmune Hepatitis (AIH) is a chronic inflammatory liver disease caused by an imbalance in immune tolerance.

A global systematic review published in The Lancet Gastroenterology & Hepatologyshows that the global prevalence of AIH is approximately 15.65 per 100,000 people, showing a continuous upward trend over the past decades.

Although glucocorticoids combined with azathioprine remain the first-line treatment recommended by international guidelines, issues such as long-term relapse risks, drug toxicity, and insufficient response in some patients still persist.

Currently, novel therapeutic strategies centered on B cell regulation, T cell immune tolerance reconstruction, and inflammatory pathway modulation are continuously advancing.

PBC: Fibrosis Reversal Remains an Important R&D Direction

Primary Biliary Cholangitis (PBC) is a chronic cholestatic autoimmune liver disease.

In recent years, innovative therapies such as PPAR agonists and FXR modulators have successively received regulatory approval, providing patients with new treatment options.

However, disease progression, bile duct injury, liver fibrosis, and symptom control remain significant challenges in current drug R&D.

IgA Nephropathy: The Era of Mechanism-Directed Therapy is Approaching

IgA Nephropathy (IgAN) is one of the most common primary glomerular diseases globally.

The currently widely accepted “Multi-Hit Hypothesis” posits that the formation of galactose-deficient IgA1 (Gd-IgA1) and the deposition of its immune complexes constitute the core mechanism of disease onset and progression.

Recently, sustained progress has been made in APRIL inhibitors, BAFF modulators, complement inhibitors, and intestinal mucosal immunomodulatory therapies. This has made IgAN one of the most active fields in global kidney disease R&D.

Translational Challenges Faced by Preclinical Research

Despite the continuous development of organoids, organs-on-chips, and AI-assisted R&D, animal models remain a crucial bridge connecting basic research and clinical development.

• AIH models face the problem of difficulty in stably reproducing chronic disease progression.
• PBC models still have limitations in simulating disease heterogeneity and fibrosis.
• IgAN models are impacted by the structural differences in IgA between humans and rodents.

Therefore, establishing a disease model system that is stable, reproducible, and clinically relevant has become an important foundation for improving the efficiency of autoimmune drug R&D.

HkeyBio Disease Model Platform

In response to the above challenges, HkeyBio has established a standardized disease model system covering AIH, PBC, and IgAN.

The platform focuses heavily on:

• Optimization of animal strain selection.
• Optimization of disease induction protocols.
• Establishment of pathological evaluation systems.
• Construction of biomarker systems.
• Standardization of experimental quality control.
• Conducting systematic research.

Currently, the platform can support:

• Drug candidate screening.
• Pharmacodynamic evaluation.
• Mechanistic studies.
• Biomarker development.
• Dose exploration.
• Combination therapy research.

Advancing the Construction of Non-Human Primate Research Capabilities

In addition to the rodent platform, HkeyBio is continuously advancing the development of NHP research systems related to AIH, PBC, and IgAN.

Because non-human primates share high similarity with humans in immune system composition, genomic structure, and pharmacokinetic profiles, they possess significant translational value in the development of innovative biologics.

In the future, the relevant platforms are expected to support:

• PK/PD evaluation.
• Humanized antibody research.
• Biomarker monitoring.
• Immunogenicity evaluation.
• Clinical dose prediction.
• IND-enabling studies.

Building a Translational Medicine Platform Covering Drug Discovery to IND Phase

By integrating the rodent model platform with NHP research capabilities, HkeyBio is building a complete R&D chain spanning: Target Validation -> Candidate Molecule Screening -> Efficacy Evaluation -> Mechanistic Studies -> Biomarker Development -> Translational Research -> IND Support

The company hopes that by improving the translational predictive capability of preclinical research, it can help partners optimize R&D decision-making, reduce development risks, and drive innovative therapies into the clinical phase more efficiently.

About HkeyBio

HkeyBio is a preclinical Contract Research Organization (CRO) focused on autoimmune and inflammatory diseases, dedicated to providing in vivo efficacy evaluation and translational medicine research services to global biotechnology companies, pharmaceutical enterprises, and research institutions.

The company possesses capabilities encompassing rodent models, non-human primate research platforms, pharmacodynamic evaluations, biomarker analysis, and IND-enabling studies, continuously driving the translation of innovative drugs from basic research to clinical development stages.

Media & Business Inquiry:

• Website: www.hkeybio.com
• Email: tech@hkeybio.com
• LinkedIn: HKEYBIO (禾开生物)

References

• Hahn JW, Yang HR, Moon JS, et al. Global incidence and prevalence of autoimmune hepatitis, 1970–2022: a systematic review and meta-analysis.EClinicalMedicine. 2023;65:102280.
• Mack CL, Adams D, Assis DN, et al. Diagnosis and Management of Autoimmune Hepatitis.Hepatology. 2020;72(2):671–722.
• European Association for the Study of the Liver (EASL). EASL Clinical Practice Guidelines: Autoimmune hepatitis.Journal of Hepatology. 2015;63(4):971–1004.
• Lindor KD, Bowlus CL, Boyer J, et al. Primary Biliary Cholangitis: 2018 Practice Guidance.Hepatology. 2019;69(1):394–419.
• KDIGO Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases.Kidney International. 2021;100(4S):S1–S276.
• Suzuki H, Kiryluk K, Novak J, et al. The pathophysiology of IgA nephropathy.Journal of the American Society of Nephrology. 2011;22(10):1795–1803.
• International Council for Harmonisation (ICH). ICH S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.

 

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SOURCE HKeyBio