Korea BIO and

Status of Bio Industry in Korea

Korea Bio Industry 2

Korea Biotechnology Industry Organization

History

1982. Korea Biotechnology Research Association(KBRA) founded

1991.11 Bio-industry Association of Korea(BAK) founded

2000. 7 Korea Bio-venture Association(KOBIOVEN) founded

2008.11 BAK, KOBIOVEN and KBRA merged into KoreaBIO

Korea Bio Industry 3

Korea Biotechnology Industry Organization(KoreaBIO)

• Korea Bio Park consist of 3 buildings with 22 Companies.

• 2005-2011(6 years)

• 2006. 5 – Land supply for Pangyo Techno Valley was approved.

• Hand in Business plan named ‘Korea Bio Park Project’

• Move in May 2011

Korea Bio Park

Korea Bio Industry 4

Korea Biotechnology Industry Organization

Member companies

Most of the top pharmaceutical companies

Most of 50 bio-technology companies listed on the Kosdaq

They have worked in bio-technology, pharmaceutical, medical device et al

(Total : about 300 member companies)

<Top 10 Pharm Companies in Korea>

Rank Name Sales(KRW bil.)

1 Yuhan Pharm 1,018

2 Green Cross 975

3 Daewoong Pharma 727

4 Hanmi Pharm 582

5 Dong A ST 568

6 Chong Kun Dang 544

7 Kwangdong 513

8 Jeil Pharm 413

9 JW Choongwae 413

10 LG Life Science 412

Korea Bio Industry 5

Korea Biotechnology Industry Organization

Main Business Area

Korea Bio Industry 6

Korea Biotechnology Industry Organization

MOU with China BPBC VIP China Visit

MOU with China science technology cluster, ChangPyungWonin ChungKwanCun nearby Beijing

Korea Bio Industry 7

Korea Biotechnology Industry Organization

MOU with Australia AusBiotech

Business matching with Australia and

Korea companies April in Bio Korea

2015 period.

ContentsI. Government

II. Industry

III. Hospital

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Korea Bio Industry 9

GovernmentPart. I

Korea Bio Industry 10

The History of Biotechnology in Korea

Year Content

1982 Foundation of the Genetic Engineers Association composed of seventeen preeminent professors and scientists from the field

1983 Enactment of the Genetic Engineering Support Act (currently Biotechnology Support Act)

1985 Foundation of the Korea Research Institute Bioscience and Biotechnology Foundation of the Korea Biotechnology Association (Now known as the Korean Society for Biotechnology and Bioengineering)

1989 Establishment of the Bioindustry Development Strategy and the Korean Society forMolecular Biology (Now known as the Korean Society for Molecular and Cellular Biology)

1991 Establishment of the Korea Bioindustry Association

1994 Establishment of the 1st Basic Plan for Biotechnology Support, Biotech 2000

1995 Long-term Vision for the Bioindustry Development (currently the Ministry of Trade, Industry & Energy)

1997 Legislation of the Guidelines on Genetic Recombination Experiments (The Ministry of Health & Welfare)-Foundation of the Biotechnology Safety and Ethics Association

1998 Enactment of the Brain Research Promotion Act; foundation of the KAIST Brain Science Research Center and the Bio Venture Company Support Center

1999 Establishment of the Basic Plan for Brain Research Promotion (valid 1998-2007)The 21st Century Frontier R&D Project Plan (currently the Ministry of Education)

2000 Designation of the Bioindustry as one of the government’s key industries for development; establishment of the BioindustryDevelopment Plan (currently the Ministry of Trade,Industry & Energy)

2001 Enactment of the Trans-boundary Movement, Etc. of Living Modified Organisms Act; Designation of biotechnology as core strategic technology in creating new industries in the 21st century under the Basic Plan for Science and Technology

Promotion (2002-2006); foundation of Next Generation Core Environmental Technology Development Project(Ministry of Environment)

Korea Bio Industry 11

The History of Biotechnology in Korea

Year Content

2002 Establishment of vision and Strategy for Bioindustry development, biocluster projects, long and mid-term health and medical treatment development plan

2003 Publication of the first issue of Biotechnology journal

2004 Introduction of genetic recombination technology in Korea

2005 Formation of Biotechnology R&D Strategy (Office of Science and Technology Innovation, currently Ministry of Science, ICT and Future Planning) and pan-governmental drug development strategy (Office of Science and Technology Innovation,

currently Ministry of Science, ICT and Future Planning)

2006 Establishment of the 2nd Basic Plan for Biotechnology Support, Bio Vision 2016

2007 Establishment of the 2nd Basic Plan for Brain Research Promotion (2008-2017); proclamation of the Year of Biotechnology; establishment of the National Bio Resources Master Plan; opening of the National Institute of Biological

Resources (currently Ministry of Environment)

2008 Bioindustry Statistics (KS) authorized; Launch of Industrialization of Agricultural Biotechnology Support Project (Ministry of Agriculture, Food and Rural Affairs); Establishment of Science and Technologies, Basic Plan for Science and Technology

or 577 Initiatives; Launch of Korea Bio Economy Forum (currently Ministry of Trade,Industry & Energy)

2009 Enactment of the Act on the Securement, Management and Utilization of Biological Resources; Enactment of the Act on Support of Science and Technology for Food, Agriculture, and Fisheries; designation of seventeen industries in three

sectors as ‘new growth energy industries’ under the New Growth Engine Vision and Development Strategy; Launch of the HT Forum (currently Ministry of Health and Welfare)

2010 Publication of the NBIC National Technological Convergence Master PlanFoundation of Korea Bio-venture Association(KOBIOVEN)

2011 Enactment of the Special Act on Fostering and Support of pharmaceutical Industry; reformation of the National Science & Technology Commission as an administrative body under the direct instructions of the president

2012 Establishment of revision of the 2nd Basic Plan for Biotechnology Support (2012-2016)

2013 Reorganization of the National Science & Technology Commission as the National Science and Technology Council

Korea Bio Industry 12

Government Vision and R&D Investment

Net Investment in Biotechnology R&D

GDP to R&D rate is 4.36% (0.31% increase year-on-year)

Korea Bio Industry 13

25 Bio Clusters in Korea

MedivalleyMedical R&D Hub

OsongMedical R&D Hub

Korea Bio Industry 14

Status of Bio Similar

Company Original Products Progress Status

Celltrion Remicade US NDA in middle of 2015, Approval of MFDSApproval in EU, Canada, Japan

Herceptin Approval of MFDS

Rituxan clinical phase 3 in progress

Enbrel Pre-clinical in progress

Enbitux Pre-clinical in progress

Synagis, Humira, Avastin R&D

Samsung Bioepis Enbrel US NDA in 2015-2016, Europe NDA in 2016

Remicade, Humira, Herceptin, Lantus

clinical phase 3 in progress

Aprogen Remicade Japan clinical phase 3 in progressJapan NDA in late of 2015

Aranesp, Rituxan Document sumit for NDA

LG life science Enbrel Korean clinical phase 1 in progress

DaewoongPharma

Enbrel Korean clinical phase 1 in progress

Korea Bio Industry 15

Government Regulation

Domestic Pharmaceuticals Trends

Source : Dataguide, KDB Daewoo Security

Korean Domestic Market is Government Regulation’s Function

0

100

200

300

400

500

600

00 01 02 03 04 05 06 07 08 09 10 11 12 13

(100= 2000.1.1)

2006.11Drug price reasonable

Policy

2010.5Rebate

dual punishment system

2012.4Drug price

Reneual

2014.2Market real price

system (Scheduled)

Reference price system(TBD)

2008Global

Recession

- It’s been accepted trends before Global Cooperation

Korea Bio Industry 16

IndustryPart. II

Korea Bio Industry 17

Bio-tech Company Global Activities

Global pharmaceuticals

Bio-tech company

Laboratory

Unmet needs

License outor

M&A

Source: KDB Daewoo Security

Value ChainType Korean Golobal

M&A SD Inverness Medical

Innovations(USA)

Co-

operation

Binex Nichi-Iko Pharmaceutical

(Japan)

Joint

Venture

Donga ST

Pharm.

Meiji Seika Pharma

(Japan)

Genexine Ajinomoto(Japan)

ILKO(Turkey)

Tech.

Transfer

Meditox Allergan(USA)

Pharmabcine 3SBio(China)

Triphase(USA)

Hanmi Pharm. Lilly(USA)

Altegen Cristalia(Brasil)

Korea Bio Industry 18

Top Korean Conglomerates invest into Bio Industry

Investment in Bio industry

Global Pharmaceuticals Promoting Fund

1st Global Pharmaceuticals Promoting Fund 100 mil $ (INTERVEST Venture Capital)

2nd Global Pharmaceuticals Promoting Fund 135 mil $ (Korea Investment Partners)

Seoul Global Bio-Medical Fund for New growth Industry

70 mil $ (Hanwha Investment)

Bio-Pharmaceutical Fund 10-30 mil $ (Hanwha Investment) made about 20 funds

Korea Bio Industry 19

Giant Going into Medical device

Samsung investment 2 billion in medical device (acquired Medison)

SK investment in Nanoentech

Biological drugs

2 billion investment in biosimilar (Samsung Biologics with Qunitiles)

Celltrion getting 200 million investment from Temasek

LG and Hanwha is also, investing in biosimilars

Regenerative medicine

Smart Healthcare

Stem-cell research, later state clinical development

Feasibility study undergoing with 10,000 diabetic patients

Recent Highlights in Korea

Korea Bio Industry 20

HospitalPart. III

Korea Bio Industry 21

Cure Diagnosis Care & Prevention

Molecular DiagnosisMedical Devices

Pharmaceuticals CompanyDNA sequencing

Medical service effectiveness improvement opportunity cost reduction

Healthcare Service Trends

Technology Trends

Small Molecular Protein -mAB DNA, RNACell

No mere New Blockbuster Personalized Medicine, incurable disease cure

Early Commercialization stage

Novel Therapeutics' R&D stageBio-tech Research Trends

Korea Bio Industry 22

Samsung Medical Center

Source : Samsung Medical Center BMCC, KoreaBIO

Connect

Open Innovation for Medical Devices

(Medical Doctor, Investor, Counselor)

Education

Conference

Seminar

News letter

Consulting

On Demand Consulting

In Depth Consulting

- Government Infra Project- Benchmark “UCSD CONNECT”

Korea Bio Industry 23

Asan Medical Center

Source : Asan Medical Center, KoreaBIO

Guest House for company

11 companies

PRISM

Non-Clinical R&D Support System

Cancer12% of Korean Cancer Patients

Personalized Cancer Medicine Center

CJ, Samyang, DNA Links, Crystalgenomics,

Meta Bio, Neomics, Genolution

Korea Bio Industry 24

Nationals Cancer Center

Source : National Canter Center, KoreaBIO

0.T.T.

(Office of Technology

Transfer)

R & D

IP

Technology Tansfer

Korea Bio Industry 25

Thank you

Korea Biotechnology Industry Organization