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Nissei Bilis Co.,Ltd.

Table of Contents

Nissei Bilis Co., Ltd. (hereinafter referred to as Nissei Bilis) conducts studies across multiple disease areas with an emphasis on pharmacology/pharmacodynamics (PD) studies. This overview describes the features of the company’s nonclinical studies, examples of disease models, and case studies. Please use this as a reference when selecting a contract research partner.

Features of Nissei Bilis Co.,Ltd.’ Non-Clinical Contract Research Services

Comprehensive toxicity studies

Nissei Bilis Co.,Ltd. provides a range of toxicity studies—including acute, subacute, and chronic studies—enabling comprehensive safety evaluation of pharmaceuticals and medical devices. The company also conducts tumorigenicity tests using immunodeficient mice and cytotoxicity assays to characterize drug effects in detail.

Biocompatibility Testing

Nissei Bilis Co.,Ltd. an extensive menu of biological safety/biocompatibility tests, including skin irritation, sensitization, and genotoxicity. The team supports safety evaluations for medical devices and regenerative medical products. Assessments are performed under conditions aligned with intended use—for example, implantation and hemocompatibility evaluations—to generate reliable data.

Use of advanced animal models

Nissei Bilis Co.,Ltd. conducts nonclinical studies using advanced animal models, such as myocardial infarction and stroke models, enabling evaluation of new drugs’ efficacy and safety in disease-relevant contexts. The company also performs general toxicity and tumorigenicity studies using severely immunodeficient animals, which support development of therapies for specific diseases.

3 Specialized Pre-clinical CROs for Advanced Drug Discovery

Representative Disease Models at Nissei Bilis Co.,Ltd.

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.

Cerebral infarction and cerebral edema models

Models include Mongolian gerbils and rats with bilateral common carotid artery occlusion (BCCAO); mice and rats with middle cerebral artery occlusion (MCAO) using the nylon-filament method with ischemia–reperfusion; rats with four-vessel occlusion (4-VO); and young rats with perinatal hypoxic–ischemic encephalopathy.

Heart failure models

Models include pacing-induced heart failure (dog); low-output acute heart failure (dog); propranolol-induced heart failure (dog); J2N-k hamster (dilated cardiomyopathy); and porcine myosin–induced myocarditis (rat).

Non-Clinical case examples at Nissei Bilis Co.,Ltd.

No case studies are currently listed on the official website.

Corporate information

Nissei Bilis Co.,Ltd. operates two primary divisions: the Trading Division, which sells raw materials for chemicals, pharmaceuticals, and food products; and the Contract Business Division, which conducts nonclinical studies. The Contract Business Division contributes to healthcare and human health through pharmacology/pharmacodynamics (PD) and safety testing.

Address	2-4-9 Bingo-machi, Chuo-ku, Osaka-shi, Osaka, Japan
Tel	06-6202-6338
Website	https://www.nissei-bilis.com/

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.

Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)

SMC Laboratories, Inc. 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, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.

Consult study design and disease model development
with SMC Laboratories, Inc.

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Safety Studies
Comprehensive Safety Evaluation for FIH Applications

Labcorp Holdings Inc.
(Labcorp Drug Development)

Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)

Labcorp Holdings Inc. 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 Holdings Inc.’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.

Consult Labcorp Holdings Inc.
Discuss GLP/ICH-compliant study design for your FIH submission.

To labcorp.
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Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation

PhoenixBio Co., Ltd.

Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)

PhoenixBio Co., Ltd.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 Co., Ltd. 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 Co., Ltd. delivers unmatched analytical precision and consistency.

Consult Phoenix Bio for PK/PD analysis with a clinical focus

Phoenix Bio.
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