Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ......

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Osong factory completion in 2013. South Korean PICS/GMP Guidelines ©Komipharm International Australia Pty Ltd 1

Transcript of Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ......

Page 1: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

Osong factory completion in 2013.South Korean PICS/GMP Guidelines

©Komipharm International Australia Pty Ltd 1

Page 2: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

Company History & Overview

• Yong-Jin Yang – Chairman Komipharm International

• Yong-Jin Yang has over 35 years of experience in the management of pharmaceutical companies.

• In 1981 he established Joong Ang Pharm Co. specialising in the veterinary medicines.

• In 1988 Mr. Yang acquired Komipharm Co. - A veterinary vaccine R&D and manufacturer.

• In early 2001, Komipharm Co. established its human medicine division and begun Research and development of a novel anti-cancer treatment.

• By the end of 2001, Mr. Yang had listed Komipharm International Co. Ltd on the Korean stock exchange (KOSDAQ).

©Komipharm International Australia Pty Ltd 2

Page 3: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

• Komipharm International Australia was established in 2015.

• API & Tablet Manufacturing for KOMINOX.

• Komipharm International will have its human drugs for globalmanufacturing, R&D & marketing headquarters in DandenongSouth, Victoria.

• Komipharm currently exports products to 21 countries and hasover 130 distributors worldwide.

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Page 4: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

• Kominox is an arsenic-based new oral drug.

• Compared to arsenic oxides such as As2O3, Kominox showed excellent tolerability.

• Effects of sodium meta-arsenite (NaAsO2) on human cancer cells (MDA-MB-231, MCF-7 and U-87 MG).

• Kominox exerts anticancer activity and cancer pain-relieving efficacy by regulating gene expression and signal pathways in human body.

• Several human clinical trails were held in the USA; Europe; Korea and Asian countries.

• Clinical trials showed that Kominox was effective for Prostate, Breast, Brain, Blood, Lung & Liver.

• The effectiveness is on the Stem Cells and Telomerase.

• In Australia Kominox has a TGA Category B SAS registration.

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Page 5: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

Antitumor effect of Kominox in HuCCT-1 xenograft nude mouse model (After 28 days)A: Control, B: Kominox 3.5mg/kg, C: Kominox 7mg/kg, D: Gemcitabine-HCl 3.5mg/kg

Antitumor effect of Kominox in a xenograft nude mouse model

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Page 6: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

Victorian State Government Partnership

• Appointed a consultant.

• Identified Government Departments.

• Identified Ministers responsible for their constituency,

• Identified Trade ministers team.

• Department heads.

• Grant evaluation which would suite our project.

• Why LIFT?

• Komipharm South Korea vision and partnership.

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Page 7: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

Parliament & Department Networking

• Komipharm made contact on both sides of politics.

• Premier –Hon Daniel Andrews MP

• Small Business, Innovation & Trade – Hon Philip Dalidakis MLC

• Industry & Employment – Hon Wade Noonan MP

• Dandenong MP – Gabrielle Williams

• Shadow Minister for Trade & Employment- Craig Ondarchie MP

• Shadow Minister for Innovation – David Southwick MP

• Department of Eco Development –

Tony Rajic & Team

©Komipharm International Australia Pty Ltd 7

Page 8: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

Detailed Overview of the Project

• Key activities reflecting how the project funds will be spent (e.g. purchase of new equipment, etc)

• Expected outcomes (e.g., increased employment, expanded business capability and/or capacity, new product/service, etc)

• What is the demand for your proposed project (product/service) from the target market?

• Implementation Plan and Budget.

• Explain why the project is necessary?

• What will the project bring to gaps identified?

• Outline any identified risks associated with your project

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Page 9: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing
Page 10: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

Concept Design & Engineering

• Market Research for Engineering company for scope of works.

• Gaps found and merger acquisitions and transition period.

• FEED

• Concept Design

• Automation

• IT Integration

• API

• Equipment

• Laboratory

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Page 11: Osong factory completion in 2013. South Korean PICS/GMP ... · Company History & Overview ... •Komipharm International Australia was established in 2015. •API & Tablet Manufacturing

©Komipharm International Australia Pty Ltd 11

Board Of Directors & Management Team

Bong-Kyu SongDirector Osong Factory

Sang-Han KimDirector Osong Factory

Yong-Jin Yang Chairman Komipharm International Co Ltd

Heewon SeoDirector & Secretary Komipharm Int Australia Doug Neumann

Project Engineering Manager

Charles FridlenderExecutive Director Komipharm Int Australia

Shelly Freeman Legal PRO Manager

QA

MM

ADMPM

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Front Entrance

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