Solution for New Drug Development - ChemOn

Chemon

Solution for New DrugDevelopment

http://www.chemon.co.kr

Full Spectrum Service Network

Welcom

e he world is experiencing Bio Revolution, often called the 2nd Industrial Revolution. Globally,

new drugs are being made, many of which are based on biotechnology.

In the course of drug development, pre-clinical research is an indispensable step, and new

evaluations are pronounced with the appearance of new bio substances. Pacing with such

global trend, the domestic demand for pre-clinical research is rapidly increasing. At the

same time, the safety demand is also increasing proportionally.

In order to satisfy such nationwide demand, Chemon was set up on January 11, 2000 as

the 1st CRO company in private sector. With ceaseless R&D, our technical level is now

widely recognized as explained with the KGLP Certificate in Carcinogenicity which we won

in March, 2006. With many experts in diverse fields, we now are engaged in the test and

analysis of drug effect along with toxicity test. In cooperation with business partners, we

provide distinctive and one-stop service including clinical research, agency work for diverse

approvals, development and commercialization of new compounds, and so on.

We always do our best to provide our customers with the best quality service. We promise

to continue our effort as a successful partner at the pre-clinical research stage.

Cheol seong Peck, C.E.O

Welcome to Chemon

T

2

History

History

Opened Chemon Analysis Center in Gyeonggi Bio Center

KGLP Certificate(KFDA) - Phtotoxicity , Photosensitization

Designated by NIER as a Chemical substance test agency

Venture Certificate(SMBA Gyeonggi Office) - New Technology Company

KGLP Certificate(KFDA) - Carcinogenicity

Designated by MAF as an agrichemical test agency

Venture Certificate(SMBA Gyeonggi Office) - New Technology Company

Completed Yangji Lab and moved into it (Approval by KGLP)

Selected as Inni-Biz A Class

Re-certified as a venture company (SMBA Gyeonggi Office)

KGLP Certificate(KFDA) - Repeated, Reproductive, Immuno, Local

Technology Transfer(Anti-Depressant)

KGLP Certificate(KFDA) - Single Dose, Genetic Toxicology

Selected as an Inno-Biz

Certified as a venture company(SMBA)

Technology Transfer(Allergy Medication)

Chemon Inc. was established

Established an affiliate research institute

2007

2006

2005

2004

2003

2002

2001

2000

3


About Chemon

Leading Company of Pharmacology/Efficacy & Safetyevaluation in Korea1. Many experiences of validity test evaluation

2. Maintaining a lot of Cell lines, Fungus and Bacteria for perfect in vitro test

3. Accumulated Know-How and experience in experiment

GLP Certified organization1. GLP Certification : covers all field

2. Reliability : GLP Facility approved by Korea Food & Drug Association

Customer-Oriented & High-Quality Service1. Direct consulting by many different field experts

2. Full service agency that covers from launching new product to registration

in Korea Food & Drug Administration

3. All toxicity studies performed by OECD & ICH Guideline

Universal Competitive Power Security1. The business tie-up with universal CRO companies

2. Current multinational non-clinical studies achievement

● Established as the 1st CRO Company in private sector

● Selected as an Inno-biz company

● Approved as a venture company

● Consultation for New Drug Development, Contract Research Service

● One-Stop Service for new drug development

● Synergetic Effect by the foremost experts in each field

About Chemon

4

Solution For New Drug Development

Research Fields

● One-Stop Service from New Compounds to New Drug

- Efficacy Test and Analysis In Early Stage

- Toxicity/Efficacy Study

- Agency Business for Clinical Trials & Relevant Authorization

- Advice on New Drug Development

Research Fields

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Service

Service of Chemon

●Toxicity Study

General Toxicology

Single-dose toxicity study

• Studies performed in rodents and non-rodents (beagle dog)

• Studies using fixed dose, “up-and-down” and other protocols

Repeated-dose toxicity study

• Studies performed in rodents and non-rodents (beagle dog)

• Duration : from DRF and 2-4 weeks up to one year studies

• Routes : oral, intravenous, muscle, subcutaneous, percutaneous

• Toxicokinetics : evaluation of bioavailability from plasma samples

Genetic Toxicology

Microbial reverse mutation assay

• Studies used bacterial stains including Salmonella typhimurium (TA98, TA100, TA1535 and

TA1537) and Escherichia coli (WP2 and uvrA)

Chromosome aberration test

• Studies used Chinese Hamster lung cell line

Micronucleus test

• Studies performed in ICR mouse

• Detects immature erythrocytes with micronucli

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Service

Reproductive Toxicology

• Fertility and early embryonic development study in rats (SegmentⅠand ICHⅠ)

• Embryo-fetal development study in rats and rabbits (SegmentⅡand ICHⅢ )

• Pre-and post natal development and maternal function study in rats (SegmentⅢand ICHⅡ)

• One or two generation studies in rats

• Assessment of parental exposure, placental transfer, milk transfer

• Behavioural test in pups

• Extensive historical database

Immunotoxicology

Active systemic anaphylaxis (ASA)

Passive cutaneous anaphylaxis(PCA)

Skin sensitization test

Carcinogenicity study

• Species and strain : rat (Sprague-Dawley, Wistar, WistarHan, Fisher F344),

mouse (ICR, CDI, B6C3FI, C57BL/6)

• Routes of administration : oral, subcutaneous

• Toxicokinetics : alteration in kinetics over lifetime exposure

Local irritation

• Skin irritation

• Eye irritation

Phototoxic test

• Photosensitization test

• Phtotoxicity test

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Service

Categories

Safety Pharmacology

Anti-cancer

Metabolism

Digestion Trouble

Immunity

Nerve System

Menopausal Disorder

Pollutants Eliminator

Internal Organs

Beauty & Health

Others

Application

in vitro, Allograft, Xenograft

Diabetes, Osteoporosis, Sexual function improvement

Helicobacter, Gastritis, Ulcer

Allergic Trouble, Atopy, Immunity, Anti-inflammation

Memory, Depression, Dementia, Apoplexy

Blood Circulation, Arteriosclerosis, Senile Change,

Anti-Oxidizing Agent, Hyperlipemia

Nicotine, Hangover

Kidney, Liver

Whitening, Wrinkle Care, Skin Protect, Corneous Remedy

Virus / Mold infection, Obesity, Pain, Fever Remedy,

Constipation, Hair Tonic

Service of Chemon

●Efficacy Evaluation & Safety Pharmacology

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Service

●Analysis Service

- Method development and validation

- Stability testing(short or long testing)

- Physico-chemical properties

- Quality Control

- ADME studies

- Method development and validation using HPLC and LC-MS/MS

- Pharmacokinetics

- Pharmacodynamics

- Bioequivalence test

●Clinical and Histopathology

- Haematological test

- Blood biochemistry test

- Autopsy

- Tissue specimens and Histopathologic evaluation

• Microscopic finding/Photomicrograph

• Histopathologic Report

- Team of veterinary pathologists and peer review of pathological diagnostics

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Facilities

Preclinical Research CenterAddress

Area

Gross Area

Performance

334, Jeil-Ri, Yangji-Myeon, Cheoin-Gu, Yongin-Si,

Gyeonggi-Do, Korea

4,899m2

2,511m2

• Toxicity studies

• Efficacy studies

• Clinical & Histopathology test

3rd FL

2nd FL

1st FL

Others

QAU room, Archive (Samples/Documents), Temporary Date Depository

Rodent SPF Breeding Room, Rodent Autopsy Room, Histopathology Room, Clinical

Pathology Room, Reproductive Toxicology Room, Pathology Room, Genetic Toxicology

Room, Efficacy & Pharmacology Room

Behavior Checking Room, Bacterial / Cell Culture Room

Dog Breeding Room, Guinea Pig Breeding Room, Special Animal Experiment Room,

Operation Room, Autopsy Room, Carcass Room, Automatic Control Room, Research

Support Room, PM Room

4th Fl : Freezer, Boiler, Air-conditioner, Water Tank, etc.

Outdoor : Oil Tank, Emergency Generator, Infected Animal Breeding Room

Gyeonggi Bio Research Center Address

Area

Gross Area

Performance

15F, Gyeonggi Bio Center, 864-1, Iui-Dong,

Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea

607.2m2

343.2m2

• Analysis service

• Bioequivalence test

Analysis Room

Office Room

Archive(Samples/Documents/Reagents), Balance Room, Hood Room, Analysis Room,

Equipment Room, Warehouse

Business Development Department, Management Support Department, CEO’s Room,

Vice President’s Room


Facilities

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ContactInformation

Contact Information

Preclinical Research Center334, Jeil-Ri, Yangji-Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do, 449-826, Korea

TEL : +82-31-329-9900 / FAX : +82-31-329-9902

Gyeonggi Bio Research Center15F, Gyeonggi Bio Center, 864-1, Iui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, 443-766, Korea

TEL : +82-31-888-6632~6 / FAX : +82-31-888-6640

http://www.chemon.co.kr I e-mail : [email protected]

Location

Suwon Yongin

11

Seoul

IncheonInternational

Airport

Chemon

A company that cares for people and life,