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.

Our scientific team brings more than two decades of specialized expertise in autoimmune drug development, with members hailing from top-tier international pharmaceutical companies. We operate from strategically located R&D bases in Suzhou Industrial Park and Guangxi. These facilities are certified under the ISO 9001 quality system, adhere to GLP principles, and hold AAALAC accreditation, allowing us to combine profound biological insight with operational excellence.

HKeyBio's core offerings are built on a foundation of highly translatable disease models and an internationally compliant quality system. This creates a comprehensive solution suite for autoimmune and allergic disease research. We deliver not just animal models, but the critical capability to generate high-quality data that supports the entire drug development cycle from early discovery to IND filing.

With 50+ Non-Human Primate (NHP) models and 300+ rodent models, we precisely cover over 50 subtypes across six major disease areas (dermatology, rheumatology, gastroenterology, pulmonology, neurology, endocrinology), providing the most suitable tools for target validation, efficacy assessment, and translational research.

All studies are conducted in AAALAC-accredited facilities, in accordance with GLP principles, and adhere to the ISO 9001 quality management system. This ensures the data generated meets the review standards of major global regulators like the U.S. FDA and EMA.

Our product system ultimately serves “data-driven decision-making”. By integrating model development, efficacy evaluation, biomarker discovery, and IND filing support, we deliver not merely experimental reports, but a critical chain of evidence that de-risks R&D and accelerates clinical translation.

Obtained two authoritative certifications (AAALAC, ISO9001) and conduct studies in accordance with GLP principles, with experimental operations following FDA guidelines. Traceable and compliant data fully meets the IND filing review requirements of global regulatory authorities.

50+ NHP models + 300+ rodent models, covering 50+ subtypes across six disease systems (skin, joint, digestive, etc.), meeting the needs of the entire R&D cycle from target screening to IND filing.

Successfully supported over 500 IND filings for autoimmune new drugs, excelling at solving challenges such as model validation and data compliance during filing, significantly improving approval rates and efficiency.

Core team with over 20 years of autoimmune drug development experience, all project leaders holding master’s/PhD degrees. Most members are from international pharmaceutical companies, providing full-process professional technical support.