HKeyBio

HKeyBio is a China-based, globally-focused preclinical Contract Research Organization (CRO) specializing exclusively in autoimmune and allergic diseases. The company's mission is to accelerate drug development by providing highly predictive, IND-enabling preclinical data. HKeyBio maintains R&D bases in Suzhou Industrial Park and Guangxi, China, with additional business offices in Boston, Massachusetts, and San Francisco, USA.

HKeyBio offers a comprehensive suite of in vivo pharmacology services, including efficacy assessment, mechanism-of-action research, and translational biomarker analysis. Its core offerings include an industry-leading portfolio of over 50 non-human primate (NHP) models and more than 300 rodent models, covering over 50 disease subtypes across six major systems such as skin, joint, and digestive. The company also utilizes human tissue culture, ex vivo modeling, and organ-on-a-chip platforms to elucidate drug mechanisms and pharmacological effects. HKeyBio supports biotech and pharmaceutical companies throughout the drug discovery process, from early screening to IND filing.

In recent developments, HKeyBio launched its "NHP Fast-PoC" program in June 2026, designed to provide cost-effective pharmacokinetic/pharmacodynamic (PK/PD) and developability data using cynomolgus monkeys. Also in June 2026, the company introduced new preclinical disease model platforms for Autoimmune Hepatitis (AIH), Primary Biliary Cholangitis (PBC), and IgA Nephropathy (IgAN). Earlier in 2026, HKeyBio unveiled the HKEY-NHP-onChip™ 1.1, described as the world's first NHP in vitro model for autoimmune and allergic diseases, and the world's first NHP Hidradenitis Suppurativa (HS) model. The company's facilities are certified under ISO 9001, adhere to GLP principles, and hold AAALAC accreditation, ensuring global regulatory acceptance of its data.