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PhoenixBio

Table of Contents
Table of Contents

PhoenixBio specializes in studies using PXB mice, a high-quality human hepatocyte chimeric mouse model. The following summarizes the features of PhoenixBio’s nonclinical studies, an example of a disease model, and representative case studies. Use this information when evaluating contract research providers.

Features of PhoenixBio’s Contract Non-Clinical Testing Services

Use of human hepatocyte chimeric mice (PXB mice)

PhoenixBio specializes in nonclinical studies using PXB mice. In this model, ≥70% of the liver is replaced with human hepatocytes, which more closely reflects drug metabolism in humans. This enables pharmaceutical sponsors to obtain reliable data to evaluate the efficacy and safety of new compounds under conditions that closely approximate human physiology.

Extensive animal disease models

PhoenixBio maintains a diverse portfolio of animal disease models and conducts nonclinical studies across a broad range of indications. In new drug development targeting specific diseases, PhoenixBio selects appropriate models and conducts rapid, efficient efficacy evaluations, enabling timely generation of the required data.

High-quality safety and efficacy/pharmacology studies

Safety studies and efficacy/pharmacology studies are conducted in accordance with applicable guidelines, providing reliable data for critical stages of drug development.

Examples of Disease Models Offered by PhoenixBio

It is essential to go through the testing of candidate compounds in animal models that reproduce the target disease before advancing to clinical trials.

However, clinically relevant disease models may not always exist, thus there are demands for animal models with strong clinical correlation.

Below are some examples of disease models offered at Ina Research.

MASH Disease Model – "MASH-c/PXB® Mouse"

A NASH-like disease model generated by feeding PXB mice (human hepatocyte chimeric mice) a CDAHFD diet (choline-deficient, amino acid-restricted, very high-fat diet) for 12 weeks. Hepatocyte ballooning and Mallory–Denk–like bodies can be observed, along with inflammatory responses and elevated human ALT-1.

NASH disease model: “NASH-g/PXB mouse”

A NASH-like disease model generated by feeding human hepatocyte chimeric mice a GAN diet for 30 weeks. Hepatocyte ballooning and Mallory–Denk–like bodies can be observed, along with inflammatory responses and elevated human ALT-1.

PhoenixBio Non-Clinical Case Studies

Human PK prediction (quantitative prediction)

PXB mice, monkeys, and rats were used to compare and evaluate predicted human clearance for 30 compounds. By comparing initial pharmacokinetic parameters, it is possible to assess absorption from the gastrointestinal tract, distribution to tissues, hepatic metabolism, and urinary elimination. This assessment supports the design of drugs with favorable efficacy and safety profiles and the planning of appropriate clinical studies.

Reference: PhoenixBio official websitehttps://phoenixbio.co.jp/services/dmpk-studies.html

Human metabolite prediction (qualitative prediction)

Lamotrigine was used to predict human metabolites by comparing data from PXB mice with control mice. By observing the in vivo time course, blood-level monitoring and the effects of multi-drug co-administration can be evaluated.

Reference: PhoenixBio official websitehttps://phoenixbio.co.jp/services/dmpk-studies.html

PhoenixBio Company Information

PhoenixBio is developing a new business that provides human hepatocyte functionality in an easy-to-use format for a variety of applications. The company consistently produces more than 4,000 PXB mice per year.

Address 3-4-1 Kagamiyama, Higashihiroshima City, Hiroshima Prefecture, Japan
Tel 082-431-0016
Website https://phoenixbio.co.jp/
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
SMC Laboratories, Inc.
Reference: SMC Laboratories official website (https://www.smccro-lab.com/jp/)
  • SMC Laboratories has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
  • From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.

  • With flexible small-scale study options and strong technical support, SMC Laboratories is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
labcorp
(Labcorp Drug Development)
labcorp
Reference: labcorp official website (https://jp.labcorp.com/)
  • labcorp provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
  • The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
  • labcorp’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio
PhoenixBio
Source: PhoenixBio Official Website (https://phoenixbio.co.jp/)
  • PhoenixBio offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
  • With advanced LC-MS/MS-based bioanalysis, PhoenixBio provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.

  • The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio delivers unmatched analytical precision and consistency.

Consult Phoenix Bio for PK/PD analysis with a clinical focus
By region
list of animal models
Expertise & Track Record
3 Recommended CRO for Non-Clinical Studies