HKEY-AI2Vivo™ 1.0 supports the move from computational hypotheses to in vivo translational evidence in autoimmune and allergy research

BOSTON and SUZHOU, China, July 30, 2026 /PRNewswire/ -- HKeyBio has established HKEY-AI2Vivo™ 1.0, its AI Candidate In Vivo Validation Acceleration Program. The program supports AI drug-discovery teams in translating AI-generated targets, molecules and mechanism hypotheses into in vivo pharmacology, mechanism, PK/PD, biomarker and pre-IND translational evidence in autoimmune and allergy disease models.

HKEY-AI2Vivo™ 1.0 at a Glance

What it is: HKEY-AI2Vivo™ 1.0 is HKeyBio's in vivo validation service framework for AI-generated drug candidates.

Problem addressed: It helps evaluate whether computational candidates can generate interpretable pharmacology, mechanism and translational evidence in disease-relevant in vivo models.

Use cases: The service is designed for AI drug discovery, AI antibody design, AI protein design, overseas biotech programs and pre-IND strategy evaluation.

HKeyBio capability link: The framework draws on HKeyBio's autoimmune and allergy disease models, NHP translational research, pathology, immune assays, PK/PD and biomarker analysis.

AI-generated candidates still need disease-relevant in vivo validation

AI can accelerate target discovery, molecule generation and antibody design, but disease-relevant pharmacology remains a critical bottleneck before candidates can advance. For autoimmune and allergy programs, drug developers need interpretable evidence across in vivo efficacy, pathology, immune phenotyping, PK/PD and biomarkers.

HKEY-AI2Vivo™ 1.0 is structured around three validation needs

1. AI Candidate Quick Screen

Designed for early-stage triage to help teams determine whether a candidate or mechanism hypothesis warrants further in vivo evaluation.

2. AI Autoimmune PoC Package

Integrates efficacy evaluation, immune phenotyping, pathology, PK/PD and biomarker analysis for candidate selection, financing, business development and pre-IND strategy discussions.

3. AI-Designed Biologics NHP Fast-PoM

Supports small-scale NHP mechanism-of-action studies for AI-designed antibodies, bispecifics, multispecifics and engineered proteins before IND-enabling development.

HKeyBio provides a standardized path from intake to translational reporting

The program may include an AI Candidate Validation Intake Form, feasibility assessment, disease model recommendation, endpoint strategy, PK/PD planning, NHP necessity assessment and English-language translational evidence reporting.

"AI is accelerating drug discovery, but disease-relevant in vivo evidence remains a critical step before candidates can move forward," said the Head of Translational Medicine at HKeyBio. "HKeyBio aims to be the validation partner that helps AI-native biotech teams move from computational candidates to pharmacology, mechanism, PK/PD, NHP and pre-IND evidence packages."

About HKeyBio

HKeyBio is a preclinical CRO specializing in autoimmune and allergic diseases, providing full-process in vivo pharmacodynamic services. Positioned as an autoimmune disease model expert, HKeyBio has established more than 50 NHP autoimmune and allergic disease models, over 500 autoimmune and allergic disease animal models, and has accumulated experience supporting more than 500 IND applications in autoimmune diseases.

For more information, please contact:

Website: www.hkeybio.com 

Email: tech@hkeybio.com 

Source note: Company information provided by HKeyBio, as of July 2026.