HKeyBio is a globally focused preclinical CRO headquartered in Suzhou, China, with additional presence in the United States, supporting pharmaceutical and biotechnology companies in early drug development. The company is dedicated exclusively to autoimmune and allergic diseases, positioning itself as a specialist partner in these complex therapeutic areas.

The organisation provides end-to-end preclinical and translational research services, helping clients move from target discovery through to IND submission and clinical trial readiness. It has supported more than 500 successful IND filings globally, reflecting its strong experience in regulatory-aligned preclinical development.

HKeyBio’s core strength lies in its advanced non-human primate (NHP) model platforms and extensive disease model libraries, which are designed to closely replicate human disease biology and improve clinical predictability. The company has developed a large database of autoimmune and allergy models, enabling more accurate evaluation of drug efficacy, safety and mechanism of action.

In addition to in vivo capabilities, HKeyBio is expanding into integrated in vitro platforms such as organ-on-chip systems and organoid models, supporting high-throughput screening and translational research. This dual in vitro–in vivo approach helps reduce development risk and accelerate decision-making in early drug development.

The company serves a global client base, including emerging biotech firms and large pharmaceutical companies, and operates under quality systems aligned with ISO standards, GLP principles and international research compliance frameworks.

Key products and services

Preclinical research and IND-enabling studies

• Pharmacology, pharmacokinetics (PK) and toxicology studies
• IND-enabling data generation and regulatory support
• Preclinical trial design and execution

Autoimmune and allergic disease models

• Extensive model library covering hundreds of disease types
• Non-human primate (NHP) disease models for high translational relevance
• Rodent and multi-species model systems

Translational research platforms

• HKEY-AIDMD™ model database for autoimmune diseases
• HKEY-NHP-onChip™ organ-on-chip platform
• Integrated in vitro–in vivo research strategies

Bioanalytical and laboratory services

• ELISA, flow cytometry, PCR and immunoassays
• Biomarker analysis and mechanism-of-action studies
• Histopathology and clinical pathology testing

Custom model development and screening

• Disease model design and validation (3–6 month timelines)
• High-throughput compound screening and lead optimisation
• Biomarker discovery and single-cell omics analysis

By combining deep expertise in autoimmune biology with advanced translational platforms and high-fidelity disease models, HKeyBio enables pharmaceutical and biotechnology companies to de-risk drug development and accelerate progression to clinical trials. Its focus on predictive preclinical data, integrated research capabilities and global delivery model positions the company as a specialised CRO partner for next-generation therapies in immunology and allergy.