Autoimmune disease preclinical CRO, NHP disease models, IND-enabling CRO Manufacturer & Supplier

500⁺Successful

IND Submissions

We have supported over 500 IND applications for autoimmune drugs, including substantial experience with U.S. FDA filings, demonstrating deep regulatory expertise.
50 ⁺ High-Translation
NHP Disease Models

We possess an industry-leading portfolio of Non-Human Primate (NHP) models for autoimmune & allergic diseases, with high clinical relevance to bridge the translational gap.
The World's Most Diverse Autoimmune Model Data Matrix

We have built and are continuously expanding the world’s largest proprietary database, covering over 300+ autoimmune disease models with unparalleled diversity and depth.
Global Compliance Assurance & Comprehensive Data Sovereignty

Our facilities are certified under the ISO 9001 quality system, adhere to GLP principles, and hold AAALAC accreditation, ensuring global regulatory acceptance of data.

ABOUT US

HKeyBio is a China-based, globally-focused preclinical CRO dedicated exclusively to the fields of autoimmune and allergic diseases. With a track record of supporting over 500 successful IND filings, we have established ourselves as a trusted partner for biotech and pharmaceutical companies navigating the complex journey from drug discovery to clinical trials.

Our mission is to accelerate your drug development by delivering highly predictive, IND-enabling preclinical data. This is powered by our globally leading Non-Human Primate (NHP) model platform and the world's most diverse autoimmune model data matrix.

PROFESSIONAL CERTIFICATIONS & CLIENT RECOGNITION

Quality and credibility are the cornerstones of HKeyBio's development. We have not only established a rigorous quality management system but have also earned widespread recognition from both partners and the academic community.

PRODUCT CATEGORY

We provide a diverse product portfolio and excellent services

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Non-Human Primate (NHP) Models

Non-Human Primate (NHP) Models

50+ highly human-simulated NHP autoimmune disease models covering skin, joint, digestive, respiratory and other systems. Deliver preclinical data closest to human physiology, significantly improving drug translation efficiency.
Rodent Animal Models

Rodent Animal Models

500+ models covering 50+ disease subtypes such as rheumatoid arthritis, systemic lupus erythematosus, and psoriasis, catering to target validation, efficacy screening and mechanism research needs in different stages of new drug R&D.
Human Tissues & Ex Vivo Models

Human Tissues & Ex Vivo Models

We provide comprehensive target validation and efficacy services utilizing human tissue culture, ex vivo modeling, and organ-on-a-chip platforms. These services elucidate the mechanism of action (MOA) and pharmacological effects of drugs, delivering critical evidence for new drug initiation and clinical translation.
Integrated Efficacy Evaluation

Integrated Efficacy Evaluation

By integrating a multidimensional data matrix from rodent, NHP, and human ex vivo models, and leveraging multi-platform technologies including flow cytometry, pathological analysis, and cellular functional assays, we offer an end-to-end workflow from in vivo efficacy testing to biomarker detection. This ensures comprehensive, precise, and fully traceable data.
Translational Medicine & Biomarkers

Translational Medicine & Biomarkers

Leverage cutting-edge technologies such as proteomics, metabolomics and single-cell sequencing to bridge preclinical and clinical research. Discover and validate disease-related biomarkers, providing data support for clinical protocol design.
IND Filing Support

IND Filing Support

Based on 500+ autoimmune disease IND filing experiences, provide end-to-end services including study protocol design, experimental data collation, IND package compilation and problem-solving, ensuring compliant and efficient filing processes.

HOT PRODUCTS

We are more than a service provider; we are a science-driven extension of your team.

Systemic Lupus Erythematosus（SLE）

Myasthenia Gravis (MG)

Cutaneous Lupus Erythematosus（CLE）

Sjogren's Syndrome (SjS)

Rheumatoid Arthritis（RA）

DISEASE FIELD APPLICATIONS

We focus on autoimmune disease sub-fields, providing targeted preclinical research solutions for new drug R&D, covering model construction, efficacy evaluation and IND application support for various autoimmune diseases.

Cutaneous Autoimmune Diseases

Covering atopic dermatitis, psoriasis and other diseases, we provide rodent/NHP model construction, skin pathological tissue analysis, immune cell subset flow detection and other services, supporting efficacy verification and IND filing documentation for cutaneous autoimmune new drugs.
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Respiratory Autoimmune Diseases

Covering asthma, pulmonary fibrosis and other diseases, we provide efficacy evaluation services such as airway inflammation assessment and lung function testing. Combined with the clinical relevance of NHP models, we improve drug translation efficiency.
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Gastrointestinal Autoimmune Diseases

Focusing on inflammatory bowel disease (ulcerative colitis, Crohn’s disease) and other conditions, we provide intestinal pathological histology analysis, intestinal mucosal immune function detection and other services, adapting to R&D needs of different drug types such as small molecules and biological agents.
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Rheumatic Autoimmune Diseases

For rheumatoid arthritis, systemic lupus erythematosus and other diseases, relying on 50+ NHP models to replicate clinical characteristics, we provide in vivo efficacy evaluation and mechanism verification services for multi-target drugs to support R&D decision-making.
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Neurological Autoimmune Diseases

For diseases such as multiple sclerosis and myasthenia gravis, we provide dual-system models (rodent + NHP) with supporting services including neuropathological analysis, neurological function scoring, and immune cell infiltration detection, supporting mechanism research and IND filings for neurological autoimmune new drugs.
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Endocrine Autoimmune Diseases

Covering diseases such as type 1 diabetes mellitus and autoimmune thyroiditis, we provide disease model construction, endocrine function testing, and autoantibody screening services, adapting to efficacy verification and R&D needs of metabolic autoimmune new drugs.
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LATEST NEWS

Asthma and Allergy Drug Development Is Failing Too Often--A Translational Reset Is Needed: HKEY-AIRx™1.0

BOSTON and SUZHOU, China, Jan. 27, 2026 /PRNewswire/ -- HKeyBio, a preclinical CRO focused on autoimmune and allergic disease drug development, today announced a translational preclinical strategy, HKEY-AIRxTM1.0 designed to address one of the most persistent problems facing biotech leadership: why

2026-02-03

Company News

HKeyBio Launches The HKEY-AIDMD 3.0--a Next-Generation Platform To Crack The Toughest Challenge in Autoimmune And Allergy Drug Development: Multi-target Combination Strategy Optimization

The newly upgraded HKEY-AIDMD 3.0 model library features nearly 300 autoimmune and allergy-related disease models. For multiple major indications, HKeyBio has established four-dimensional (4D) model pools that simulate clinical heterogeneity, providing a mechanism-driven model selection platform for

2026-02-03

Company News

HKeyBio Lauched The Most Comprehesive Non-human Primate Autoimmune & Allergic Disease Model Matrix To Redefining Clinical Translation

BOSTON and SUZHOU, China, Sept. 23, 2025 /PRNewswire/ -- HKeyBio, a CRO specializing in preclinical and translational autoimmune-drug development, today announced the launch of HKEY-NHP-MATRIX2.0, a next-generation platform designed to improve the reliability of translating novel autoimmune and alle

2026-02-03

Company News

Welcome to Contact Us

We are committed to providing our clients with high-quality products and excellent services, aiming to establish long-term partnerships. We deeply understand the importance of efficient communication for global collaboration. Therefore, we pledge to provide an initial response within 24 hours and are flexible to schedule meetings at your convenience, accommodating time zones worldwide.

If you are interested in our products or services, please feel free to contact us at any time. We are dedicated to supporting you and contributing to the success of your projects.

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Asthma and Allergy Drug Development Is Failing Too Often--A Translational Reset Is Needed: HKEY-AIRx™1.0

HKeyBio Launches The HKEY-AIDMD 3.0--a Next-Generation Platform To Crack The Toughest Challenge in Autoimmune And Allergy Drug Development: Multi-target Combination Strategy Optimization

HKeyBio Lauched The Most Comprehesive Non-human Primate Autoimmune & Allergic Disease Model Matrix To Redefining Clinical Translation

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