Current Status of Biotech Industry in Korea : Strengths and Challenges

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Current Status of Biotech Industry in Korea
Strengths and Challenges
EU-Korea Biotech Seminar
December 2005
Jin-Ho Seo, Ph.D. Director, Bio-MAX Institute,
Seoul National University Bioindustry
Association of Korea(BAK)
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CONTENTS
?. Fundamental Structure of Bioindustry in Korea
1. History of Korean Bioindustry 2.
Bioindustry Fields 3. Government Role and
RD Investment 4. Journal Patent 5.
Driving System ?. New Breakthroughs of
Bioindustry in Korea 1. Vision for
BioSociety and Goal of Bioindustry 2. Basic
Direction of Bioindustry Policy 3.
Strengthening Strategy of Competitiveness on
Bioindustry 4. What We Focus On ?.
Current Status of Bioindustry in Korea 1.
Category of Companies 2. Manpower of
Companies 3. Market Size 4. Example
of Bio-Products 5. Trend of Technology
Development 6. Investment by Major
Corporates 7. Industrialization by Major
Corporates 8. Launching Trend of New
Bio-products 9. SWOT of the Korean
Bioindustry 10. Strengths and Challenges ?.
Future of Korean Bioindustry 1. Prospect
for the Future 2. Strategy for the Future
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I. Fundamental Structure of Bioindustry in Korea
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1. History of Korean Bioindustry
19801989 Technology Development Stage

• ? Introduction Development of New Biotechnology
• ? Enactment of Biotechnology Promotion Law, 1983
• ? Establishment of Biotechnology Departments
  Research Institutes in Universities, 1984
• ? Establishment of the Korea Research Institute
  of Bioscience Biotechnology(KRIBB), 1985

19901999 Product Manufacturing Stage
? Establishment of Bioindustry Association of
Korea(BAK), 1991 ? Formalizing of Biotech 2000
Program(MOST), 1994 ? Proclaim of Bioindustry
Vision 2000(MOCIE), 1994 ? Development of
Bioprocess Technology Launching of Bio-products
2000Current Bioindustry Introduction Stage

• ? Establishment of Korean Bioindustry Development
  Strategy, 2000
• ? Key National Strategic Industry
• ? Inauguration of National Bioindustry Action
  Plan
• ? Productivity Improvement of Generic Products,
  Development of New Modified Bio-products
• ? Investment Increase in Public Private Sector

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I. Fundamental Structure of Bioindustry in Korea
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2. Bioindustry Fields
Bioindustry Fields
Source Korea Institute for Industrial
Economics Trade(KIET), 2004
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I. Fundamental Structure of Bioindustry in Korea
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3. Government Role and RD Investment
? Government Role
Government Role in Bioindustry
Source Biotechnology Promotion Law
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I. Fundamental Structure of Bioindustry in Korea
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3. Government Role and RD Investment
? Government RD Investment
Governmental Agencies US 450 million RD
Investment by 7 Ministries in 2003 US 525
million RD Investment by 8 Ministries in 2004
Industries
Research Institutes
Academia
Bioindustry Association of Korea Korea
Biotechnology Research Association Korea Bio
Venture Association Biotech Institutes in
Private Companies
Biotechnology-related Departments in
Universities University-associated Research
Institutes Science Engineering Research
Centers Biotechnology-related Societies
Korea Research Institute of Bioscience and
Biotechnology POSTECH Biotech Center Biocluster
Bio Venture Center New Region Promotion
Business Other Governmental or Public Research
Institutes
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I. Fundamental Structure of Bioindustry in Korea
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4. Journal Patent
? Case published in the Journals listed by SCI
Source Ministry of Science and
Technology(MOST), Biotechnology in Korea
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I. Fundamental Structure of Bioindustry in Korea
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4. Journal Patent
? Patent registration to the US PTO
Source Ministry of Science and
Technology(MOST), Biotechnology in Korea
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I. Fundamental Structure of Bioindustry in Korea
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5. Driving System
? Government

• ? Ministry of Commerce, Industry and
  Energy(MOCIE)
• ? Biotechnology Chemicals Industries
  Division
• ? Ministry of Science and Technology(MOST)
• ? Biotech and Environmental Technology
  Division
• ? Ministry of Education Human Resources
  Development(MOE)
• ? Ministry of Agriculture Forestry(MAF)
• ? Ministry of Health and Welfare(MOHW)
• ? Ministry of Environment(ME)
• ? Ministry of Maritime Affairs
  Fisheries(MOMAF)

• ? Korean Intellectual Property Office(KIPO)
• ? Genetic Engineering Examination
  Division
• ? Korea Food Drug Administration(KFDA)
• ? Safety Evaluation Office

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I. Fundamental Structure of Bioindustry in Korea
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5. Driving System
? Academia

• ? Biotechnology-related Departments were set up
  in around 40 Universities
• ? College of Science 60, College of
  Agriculture 25, College of Engineering 15
• ? 30 University-associated Research Institutes
  on the Genetic Engineering were established
• ? Institute of Molecular Biology and
  Genetics, Seoul National University, etc.
• ? Science Research Center(SRC) Engineering
  Research Center(ERC)
• ? Over 20 Centers in Biotechnology Area in
  the Universities
• ? Seoul National University, Korea
  University, KAIST, etc.
• ? Biotechnology-related Societies are Working
  on
• ? Korean Society for Biotechnology and
  Bioengineering(KSBB)
• ? Korean Institute of Chemical Engineering
  / Division of Biochemical Engineering, etc.

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I. Fundamental Structure of Bioindustry in Korea
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5. Driving System

• Research Institutes
• ? Biotechnology-dedicated Research Institutes

Bio-MAX Institute, Seoul National University
? SNU Bio-MAX Institute is a research
organization established in 2003 with a support
from MOCIE to carry out innovative projects
in a multidisciplinary environment
Korea Research Institute of Bioscience and
Biotechnology(KRIBB)
? Korea Research Institute of Bioscience and
Biotechnology(KRIBB) is the only government
research institute dedicated to
biotechnology research across a broad span of
expertise, from basic studies for the
fundamental understanding of life phenomena to
applied studies, established in 1985
MOGAM Biotechnology Institute
? MOGAM Biotechnology Institute is one of the
best private research institutes established in
1984 on the promotions of the research and
development in the field of Biopharmaceuticals
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I. Fundamental Structure of Bioindustry in Korea
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5. Driving System

• Research Institutes

? Biocluster
New Region Promotion Business(15)
Bio Venture Center(9)

• Biotechnology Innovation Center, Chuncheon
• Bio Venture Center, Daejeon
• Center for Biotechnology and Bioventure,
• Jeonbuk
• Bio21 Center, Kyungnam
• Biotechnology Industrialization Center,
• Dongshin University
• Biotechnology Innovation Center,
• Youngdong University
• Technology Innovation Center,
• Sangju National University
• Bioindustry Development Center, Jeju
• Marine Biotechnology Center for Functional
• Material Industry, Busan

• Bio Venture Town, Daejeon
• Bio Venture Plaza, Chuncheon
• Institute for Marine Bioindustry, Gangneung
• Biotechnology Center for Bioindustry, Jeonnam
• Biotechnology Research Center, Jeonnam
• Biohealth Industry Support Center, Kyungbuk
• Bioscience Park, Jeju
• Traditional Pharmaceutical RD Center, Chungbuk
• Animal Resources Support Center, Chungnam
• Healthcare Industry Center, Chungbuk
• Marinebio Enviromental Industry Center, Kyungbuk
• Biomaterial Industrialization Center, Daegu
• Herb Medicine Support Center, Daegu
• Bio Venture Plaza, Kyungnam
• Bio-Industry Support Center, Busan

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I. Fundamental Structure of Bioindustry in Korea
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5. Driving System

• Research Institutes

? Biotechnology-related Research Institutes
Government-donated Research Institutes
? Korea Institute of Science and
Technology(KIST) ? Korea Tomorrow Good
Research Institute(KTGRI) ? Korea Food Research
Institute(KFRI) ? Korea Institute of
Toxicology(KIT) ? Korea Biotechnology
Commercialization Center(KBCC) ? Korea
Institute of Energy Research(KIER) ? Korea
Ocean Research Development Institute(KORDI)
National and Public Research Institutes
? Korean Agency for Technology and
Standards(ATS) ? National Institute of
Health(NIH) ? National Institute of
Environmental Research(NIER) ? National
Institute of Agricultural Science and
Technology(NIAST) ? Korea Forest Research
Institute(KFRI) ? National Veterinary Research
and Quarantine Service(NVRQS) ? National
Fisheries Research and Development
Institute(NFRDI) ? National Institute of
Scientific Investigation(NISI)
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I. Fundamental Structure of Bioindustry in Korea
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5. Driving System

• Research Institutes

? Others
Private Research Institutes
? Asan Institute for Life Science ? Samsumg
Bioscience Research Institute
Research Institutes on Bioinformatics
? Korea Institute of Science and Technology
Information(KISTI) ? Agriculture and Life
Science Research Center, Seoul National
University ? Biological Research Information
Center(BRIC), Pohang University of Science and
Technology
Microorganism Depository Organizations
? Korean Collection for Type Cultures(KCTC) ?
Korean Culture Center of Microorganisms(KCCM) ?
Korean Cell Line Research Foundation
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I. Fundamental Structure of Bioindustry in Korea
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5. Driving Systems

• Industry Organizations

Bioindustry Association of Korea(BAK)
? Industrial Organization established as an
affiliated Organization of Ministry of Commerce,
Industry and Energy(MOCIE) in 1991 for the
Purpose of the Development and Growth of
Bioindustry in Korea ? Main Activities -
Formation of Bioindustry Platform -
International Cooperation in Bioindustry ?
Members General(Company 60),
Associate(Organization 19, Individual 110)
The Korea Biotechnology Research
Association(KBRA)
? Research Association established as an
affiliated Organization of Ministry of Science
and Technology(MOST) in 1982 for the
Purpose of the Support on the Development of
Biotechnology
Korea Bio Venture Association(KOBIOVEN)
? Bioventure Organization established as an
affiliated one of Ministry of Commerce,
Industry and Energy(MOCIE) in 2000
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II. New Breakthrough of Bioindustry in Korea
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1. Vision for BioSociety and Goal of Bioindustry
? Vision for BioSociety
? Transformation to BioSociety where the
Bio-Products and Services are just on Your
Hands ? The Coming BioSociety after the
Bio-Revolution of 21C through the Fusion of
Biotechnology(BT) and Information
Technology(IT)
Remaking the World
Transforming Ourselves
From Alchemy to Algeny
? Impact of Bioindustry

• The Core Contributor in Korea Economy in 21C
• ? The paradigm shift in economy from mass
  assembly industry to knowledge based industry

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II. New Breakthrough of Bioindustry in Korea
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1. Vision for BioSociety and Goal of Bioindustry

• Vision for Bioindustry

• ? Settlement as Growth Engine Industry for Next
  generation
• - Industrialization as the main force in
  Post-IT era
• Commercialization of Export-driven Bio-Product
• - Marketing of New Bio-Product in advanced
  countries
• - Globalization of Korean traditional
  Bio-Products

Export US 0.7 billion(2002) ? US 10
billion(2012)
Targeting 10 of share in Global Market
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II. New Breakthrough of Bioindustry in Korea
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2. Basic Direction of Bioindustry Policy
Creation of BioSociety for the 21st Century
Healthy BioSociety
Wealthy BioSociety
Clean BioSociety
Growth of Bioindustry

• ? Intensive Promotion of Bioindustry as a
  National Strategic Industry
• Active Lead toward Development of Bioindustry

Bioindustry Development Strategy 2005
3 Goals RD, Infra, Business Environment
12 Programmes Bio-Star Project, Biocluster,
etc.
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II. New Breakthrough of Bioindustry in Korea
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3. Strengthening Strategy of Competitiveness on
Bioindustry
? Development of Core Technology - Technology
for Mid-term Next generation
Development of Core Technology Bio-Product
? Growth Engine Industry for Next generation -
New Bio-Drug / Artificial Organ, Bio-Chip

• Bio-Star Project
• - Innovative Biotechnology Bio-Product

Expansion of Industrialization Infrastructure
? Establishment of Bio-product Manufacturing
- International authorization of GLP System -
Establishment of GCP system for Functional Active
Compound - Expansion of cGMP and Improvement
of Management
? Implementation of LMOs - Biosafety
Information Center - Foundation of Bio-hazard
Evaluation Center
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II. New Breakthrough of Bioindustry in Korea
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3. Strengthening Strategy of Competitiveness on
Bioindustry
? Activation of Biocluster - Construction of
Korea Bio-Hub - Strengthening of existing
Biocluster - Promotion of using Micro-biochip
production platform - Establishment of
platform for supporting Industrialization of
BIT technology
Strengthening Promoting of Biocluster

• Construction of Complex
• - Advanced Biopharmaceutical production
  complex
• - Bulk Vaccine production complex

? Establishment of Investment / Consulting
Company - Participation from public company,
private foreign companies - Support of
long-term investment
Promoting Global Network

• Joint RD with Foreign Countries
• Training International Standard Specialist

• Networking among Domestic Foreign association,
  companies
• and government

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II. New Breakthrough of Bioindustry in Korea
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4. What We Focus On
? Mid-term Next Generation Project

• ? Development of Therapeutic Protein by Animal
  Cell Culture
• Development of Biomaterial by Intelligence-type
  Bioinformatics
• Development of Gene Therapy for Incurable
  Diseases
• Mass Production of Protein-DNA chip System
• Development of High Value Added Protein

? Growth Engine Project New Bio-Drug /
Artificial Organ Bio-Chip
? Immunomodulator ? Drug Delivery System ? Gene
Therapy ? Cell Therapy ? cGMP Technology
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III. Current Status of Bioindustry in Korea
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1. Category of Companies

• Types of Companies
• ? No. of Companies in 2003 605
• ? No. of Companies on both RD and Sales
  of Bio-Products 432
• ? No. of Companies focusing on RD 173

Types of Bioindustry Companies in 2003
Source Korean Agency for Technology
Standards, Korea Institute for Industrial
Economics Trade,
Bioindustry Association of Korea, 2004
? 2004 ? No. of Companies in Bioindustry
About 600
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III. Current Status of Bioindustry in Korea
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1. Category of Companies
? Company Group
Large Size Group
? Above 30 Companies ? LGLS, CJ, Daesang, TS
Corporation, etc. ? Operating the fully
Integrated System on RD, Production, Marketing
Middle Size Group
? Above 70 Companies ? Dong-A Pharm., Chong
Kun Dang, Green Cross, Daewoong, etc. ? Focused
on the Competitive Core Products
Small Size Venture Group
? Above 500 Companies ? Dong Kook Pharm.,
Bioneer, Macrogen, KoBioTech, etc. ?
Individually concentrated on the Niche Fields of
RD, Production and Marketing
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III. Current Status of Bioindustry in Korea
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2. Manpower of Companies ? 2003 ? Total
11,013 ? RD Area 5,808(53) ?
Manufacturing Area 5,205(47)
Manpower of Bioindustry in 2003
Source Korean Agency for Technology
Standards, Korea Institute for Industrial
Economics Trade,
Bioindustry Association of Korea, 2004
? 2004 About 13,000
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III. Current Status of Bioindustry in Korea
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3. Market Size ? 2003 US 1,332 million
? Biopharmaceuticals 61, Non-biopharmaceuticals
39 ? Domestic Products 68, Imported
Products 32
Bioindustry Market Size in 2003
(Unit US million)
Source Korean Agency for Technology
Standards, Korea Institute for Industrial
Economics Trade,
Bioindustry Association of Korea, 2004
? 2004 About US 1,701 million
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III. Current Status of Bioindustry in Korea
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4. Example of Bio-products
? Examples of Domestic Products
? Examples of Imported Products
? Human Growth Hormone ? Vaccines
Hepatitis B Vaccine, etc. ? a-Interferon,
?-Interferon ? Antibiotics 7-ACA, etc. ?
Diagnostic Kits ? Amino Acids Lysine, etc.
? Oligosaccharides ? Microbial Agents
? Insulin ? Human Growth Hormone ?
a-Interferon, ß-Interferon ? Vaccines
Influenza, etc. ? Erythropoietin ?
Diagnostic Kits ? Equipments Bioprocess,
etc. ? Industrial Enzymes
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III. Current Status of Bioindustry in Korea
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5. Trend of Technology Development
? Upstream Technology Well Developed ?
Recombinant DNA Technology, Cell Fusion
Technology, etc. ? Downstream Technology ?
Fermentation Well Developed ? Animal
Plant Cell Culture, Separation Purification,
etc. Improving ? Emerging Technology Early
Stage ? Genomics, Proteomics, Bioinformatics,
etc.
Technology Level

• ? Use of Established Biotechnology
• ? Improvement of level on Bioprocess Technology
• ? Development of Post genomics-related New
  Technology
• ? Industrialization of Improved and New
  Bio-products
• ? Improved Bio-product
• ? New Bio-product

Trend of Technology Development
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III. Current Status of Bioindustry in Korea
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6. Investment by Major Corporates
Investment to Biotech
Company
Samsung
US 230 million by 2004
SK
US 32 million in 2001, domestic and oversea
investment
LGLS
US 85 million to Biotech, 30 million to Biotech
Ventures
Daesang
US 155 million by 2004
CJ
US 230 million by 2003
Green Cross
US 100 million by 2005
ISU Chemical
US 115 million by 2006
DooSan
US 77 million by 2004
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III. Current Status of Bioindustry in Korea
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7. Industrialization by Major Corporates
? Bio-Products of LG Life Science Ltd.
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III. Current Status of Bioindustry in Korea
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7. Industrialization by Major Corporates
? Sales of LG Life Science Ltd. from Main
Bio-Products in 2003
Sales
Euvax B Injection
Immunization against infection diseases caused by
subtypes of hepatitis B virus
29 mil.
Eutropin Injection
Short stature due to GHD or due to Tuners
syndrome
19 mil.
Boostin
Sustained-release(SR) formulation of recombinant
Bovine Somatotropin(rBST) for inducing increased
milk production in dairy cows.
8 mil.
Espogen Injection
Anemia in patients with chronic renal failure
8 mil.
Hyruan Injection
Deformative osteoarthritis of the knees or
shoulder periarthritis
6 mil.
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III. Current Status of Bioindustry in Korea
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7. Industrialization by Major Corporates
? Bio-Products of CJ Corp.
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III. Current Status of Bioindustry in Korea
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7. Industrialization by Major Corporates
? Sales of CJ Corporation from Main Bio-Products
in 2003
Sales
Lysine
Feed additives
256 mil.
Nucleic Acid
Food additives
128 mil.
7-ACA
Intermediate for cephalosporins.
27 mil.
Epokine
Treatment of anemia associated with chronic renal
failure
22 mil.
Vancomycin
Treatment for the infection due to staphylococci
and skin structure infections, etc.
8 mil.
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III. Current Status of Bioindustry in Korea
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7. Industrialization by Major Corporates
? Bio-Products of Dong-A Pharmaceutical Co., Ltd.
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III. Current Status of Bioindustry in Korea
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7. Industrialization by Major Corporates
? Sales of Dong-A Pharmaceutical Co., Ltd. from
Main Bio-Products in 2003
Sales
Growtropin
Human growth hormone
9 mil.
Vaxigrip
Influenza vaccine
7 mil.
Eporon Injection
Treatment of anemia
5 mil.
Leucostim Injection
Human granulocyte-colony stimulating factor
4 mil.
Beszyme Tab
Treatment of Indigestion and dyspepsia
4 mil.
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III. Current Status of Bioindustry in Korea
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8. Launching Trend of New Bio-Product
? Cell Tissue Therapy
Products
Application
Companies
Acellular human dermis for the repair or
replacement of damaged tissue.
Cellontech
Chondron (approved in 2001)
Autologous chondrocyte transplantation(ACT)
Tego Science
Holoderm (approved in 2002)
Cultured epidermal autograft(CEA)
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III. Current Status of Bioindustry in Korea
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8. Launching Trend of New Bio-Product
? Bio-Chip
My HPV Chip (approved in 2004)

• MyGene Inc.
• Detection of Human Papillomavirus(HPV)
• ? High sensitivity and specificity for the
  detection
• of cervical disease in early stage
• ? Minimal specimen preparation required
• ? Cost effective and user-friendly test

HPVDNAChip (approved in 2004)
? Biomedlab Co. ? Detection of Human
Papillomavirus(HPV) ? Accurate risk
determination by genotype information
? Assist diagnosis or prognosis of cervical
cancers ? Useful in vaccine development and
evaluation
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III. Current Status of Bioindustry in Korea
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9. SWOT of the Korean Bioindustry
Strength

• International Level of IT Technology
• Enthusiasm to Education
• Strong Driving Policy of Government

Opportunity

• Narrow gap in the Potential of Korea with
  Advanced Countries
• Innumerable fields to be Investigated
• Increase of the interests in Bioindustry among
  Koreans

Weakness

• Inferior in Technology Competitiveness
• Far behind level in Industrial Infrastructures
• Insufficient Investment

Threat

• Spread of the Anxiety on Bio-Products
• Monopoly of the Patents and IPR by a limited no.
  of Countries
• Speedy of Technology Development

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III. Current Status of Bioindustry in Korea
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10. Strengths and Challenges
Challenges
Strengths

• Amino Acid Food Additives
• ? Amino Acid Lysine, etc.
• ? Food Additives Nucleic Acid, etc.

• Stem Cell RD
• ? Embryo Originated Stem Cell
• ? Cloned cow, dog
• ? Development of mini pig

? Biopharmaceuticals ? Antibiotics 7-ACA,
etc. ? Gene Drug Hepatitis B Vaccine, etc

• BIT
• ? Biochip, etc.

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IV. Future of Korean Bioindustry
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1. Prospect for the Future
Creation of BioSociety for the 21st Century
Healthy BioSociety
Wealthy BioSociety
Clean BioSociety
Ready for BioSociety Growth of Bioindustry
Intensive Promotion of Bioindustry as a
National Strategic Industry
Enhancement of International Cooperation with
China, etc.
Active Lead toward Development Enlargement
of Bioindustry
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IV. Future of Korean Bioindustry
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2. Strategy for the Future
? Strong Support Policy by Government  ?
Securing the Research Manpower by Education and
Training  ? Support to Build-up of t
Infrastructures for Research and      Commercializ
ation ? Increase of RD Investment ?
Encouragement of Industry / Academia Cooperation
 ? Formulation of Consortium System by
Bio-companies ? Encouragement of International
Cooperation ? Support to Venture Capitals
Industries ? Support to Bioclusters