Single-Dose Toxicity (Acute)
- Evaluates the effects of single high-dose exposure
- Identifies dose-limiting toxicities and target organs of toxicity
Regulatory Endorsement
Humanized mice are a reliable option when relevant species are limited, as supported by ICH S4(R1) guidelines.
Humanized mice serve as an alternative to NHPs for DART studies, as recommended by the FDA.
Reduce animal testing requirements for drugs, with humanized transgenic models suggested as a new approach methodology by the FDA.
Fast-track the transition from preclinical research to regulatory approval.
Evaluate human-specific pharmacology and target-dependent safety in vivo using the clinical candidate directly.
An ideal platform for IND-enabling tox studies, especially for therapeutics with complex target cross-reactivity.
Leverage shorter breeding cycles with FDA-recognized humanized mouse models for DART studies.
Larger, synchronized cohorts to strengthen statistical power and robust datasets.
drug candidates, general
toxicology studies approved
additional client programs
currently in progress
drug candidates, reproductive toxicology
studies carried out in clinical phases
additional client programs
currently in progress
drugs received NMPA BLA approval
drug candidates received NMPA IND approval (LAG3, IL4/IL4R, 4-1BB, CCR8, CD20, CD3, TSLP)
drug candidates received FDA IND approval (CCR8, IL4/IL4R, PD-L1/4-1BB, CD3, TSLP, IL3R)
drug candidates received dual FDA/NMPA IND approvals
drug candidates used humanized mice in DART studies
drug candidate received dual FDA/TGA IND approvals
drug candidates, general toxicology has been approved
drug candidates, reproductive toxicology has been carried out in clinical phase
Biocytogen's B-HIL4/IL4RA mice were used in a repeated-dose toxicology study of LQ035, a novel inhalable anti-IL-4Rα nanobody for asthma. The study evaluated tolerability, cytokine profiles, immune markers, ADA responses, and NOAEL, demonstrating the model’s utility for safety assessment of inflammatory disease therapeutics. (Zhu et al. J Allergy Clin Immunol, 2024)
Biocytogen's B-hTL1A/hIL23A/hIL12B mice were utilized to support reproductive toxicity evaluation of cyclophosphamide. The study included comprehensive assessments of reproductive toxicity, germ cell genotoxicity, pregnancy outcomes, and embryo-fetal development, supporting DART-related safety evaluation.
Adult Reproductive Toxicity Assessment
Fetal & Developmental Toxicity Assessment
Extensive experience working with major safety assessment centers
High-standard product data can be directly used as supplementary files for IND applications
Comprehensive production and breeding data support long-term and reproductive toxicology studies
10-year gene editing expertise, closely mimic expression patterns in human or WT mice
In vivo expression, functionality, and drug binding verified to ensure clinical relevance and reproducibility
Our proprietary IVF technology enables synchronized delivery of large cohorts, with weight differences controlled within 3g
Connect with Biocytogen to explore our toxicology services and discover how humanized models can support your IND-enabling development programs.