WuXi AppTec

WuXi AppTec is a global CRO/CDMO group providing fully integrated services spanning discovery research, nonclinical development, and CMC. In Japan, WuXi AppTec Japan serves as a local liaison for overseas nonclinical facilities, acting as a project interface and technical consulting partner for Japanese clients.
This page provides an overview of WuXi AppTec’s nonclinical capabilities, representative disease models, and selected development case examples.

Features of WuXi AppTec’s Contract Services for Non-Clinical Studies

Broad and Integrated Nonclinical Development Platform

WuXi AppTec offers a comprehensive, integrated nonclinical platform encompassing safety assessment (toxicology), ADME/DMPK, bioanalysis, and analytical chemistry.All studies required to support IND-enabling programs can be conducted under a single, coordinated framework , including centralized project management. By integrating datasets across disciplines, WuXi AppTec supports optimized study design, data interpretation, and regulatory-ready reporting.

Advanced Toxicology Capabilities with Full GLP Compliance

WuXi AppTec provides toxicology services in full compliance with Good Laboratory Practice (GLP), coveringsingle-dose, repeat-dose, chronic toxicity, and carcinogenicity studies.
With large-scale animal facilities and environmentally controlled test environments, the organization supports safety evaluation from early screening through IND and NDA submission stages.
Close integration with DMPK and bioanalytical teams further enhances data consistency, scientific insight, and overall study reliability.

DMPK Expertise and Global Regulatory Readiness

Dedicated DMPK/ADME teams, supported by a global R&D network, enable studies across a wide range of molecular modalities, including small molecules, antibodies, oligonucleotides, and PROTACs.
WuXi AppTec maintains compliance with international animal welfare standards, including AAALAC accreditation, and has extensive experience supporting regulatory submissions to the FDA, EMA, and NMPA. Advanced automation and analytical technologies enable efficient data generation and timely delivery for global development programs.

Examples of Disease Models Available at WuXi AppTec

In oncology research, WuXi AppTec offersa broad portfolio of in vivo models, including cell line–derived xenografts (CDX), patient-derived xenografts (PDX), syngeneic tumor models, and humanized immune system models.
These platforms enable evaluation of tumor biology and immune interactions and are widely used in the development of oncology therapeutics, immunotherapies, and antibody–drug conjugates (ADCs).

For hematologic and cardiovascular indications, WuXi AppTec providesdisease models related to coagulation and vascular function, including thrombosis, bleeding disorders, and hemophilia models (FVIII-deficient mice), as well as models of vascular disease, hypertension, and heart failure.
These models support efficacy assessment, mechanism-of-action studies, and bleeding risk evaluation, facilitating informed decision-making throughout drug discovery and development.

WuXi AppTec Non-Clinical Case Study

Model Development to Enhance Translational Relevance

WuXi AppTec actively develops disease models designed to improve the translational relevance of nonclinical data to human clinical outcomes.
One representative example is the development of a humanized mouse model in which the murine glucose-dependent insulinotropic polypeptide receptor (GIPR) gene is replaced with its human counterpart. This model was established to support evaluation of dual-acting agents targeting both GLP-1 receptor (GLP1R) and GIPR.
By minimizing species-related differences in receptor pharmacology, this humanized model enables more predictive assessment of anti-obesity and metabolic efficacy for dual-target therapeutics such as tirzepatide and AMG133. Compared with conventional wild-type rodent models, the system provides human-relevant efficacy data and contributes to improved clinical translation of nonclinical findings.

WuXi AppTec Company Information