and Korean Pharmaceutical

Overview of KDRA, KHIDI
& Korean Pharmaceutical Industry
General Overview
Organization
In 1986 Korea Drug Research Association(KDRA) was established as
non-profit organization to cope with the introduction of a new product
patent system based on the law for fostering industrial technology
association and represents R&D based pharmaceutical & biotech
industry in Korea.
From its establishment KDRA has been working for the
development of Korean Pharmaceutical & Biotech industries promoting
the industrial technologies in pharmaceutical & biotech fields. For this
KDRA has been participating in and leading biotech R&D policymaking, strategy-formulating and improvement of advanced R&D
systems. KDRA has since 1986 engaged in mid-and long-term nat'l
R&D programs, drived and managed various kinds of R&D programs
including those sponcered by the government in several innovation
areas; NCE, NME, API, herbal medicine, New Indication, New Route of
Administration, New Formulation, New Ester, Salt or Other Noncovalent Derivative, New Dosage Form or Strength, Combination
Product etc.
Major Activities
KDRA has also been working in business partnering and
technology transfer & licensing between the pharmaceutical & biotech
industries, academic and public research organizations domestically
and internationally. For these activities, KDRA has since 2002 been
organizing annual business partnering event, InterBiz Bio-Partnering &
Investment Forum, a key conference for technology transfer &
collaboration with average 100 domestic & international companies &
orgs.
To provide the industry with additional opportunities for domestic &
global business development, KDRA has established and is managing
a distinctive subsidiary organization, PTBC(PharmaTech Business
Center) for providing services in technology transfer, licensing and
R&D collaboration activities between KDRA members and domestic &
international partners.
To cope with the global mega trends and environmental changes
surrounding the pharmaceutical industry in several areas; market,
technology, regulation and business, KDRA has since 1994
established several subsidiary associations; Association of API
Development Professionals(1994), Association of Regulatory Affairs
Professionals(2006), Association of Pharmaceutical Research
Analysis(2008), Association of Computer Aided Drug Design(2010) and
Korea Herbal Medicine Association(2011). Additionally to provide
theoretical & statistical approaches to the industry of its importance
and contribution to the promotion of national
healthcare, reduction of healthcare budget and
control & management of life threatening, chronic
and intractable diseases of the population,
KDRA has in 2010 established Innovation
Policy Research Center(InnoPol).
▶ Representing R&D based pharmaceutical & biotech Industries in
Korea
▶ Providing unified voice fostering an environment which
responds to the needs of Korean R&D based pharmaceutical &
biotech Industry
▶ Promotion of pharmaceutical & biotech R&D Activities
▶ Leading & participating in R&D policy-making in pharmaceutical
& biotech fields
▶ Planning mid-and long-term national R&D programs supported
by the government
▶ Operation of national new drug R&D consortiums and various
kinds of committees
▶ Support & management of R&D funds secured from the
government etc.
▶ Supporting services of R&D collaboration & technology diffusion
※ Establishment & Management of PTBC(PharmaTech Business Center)
※ Technology Evaluation & Valuation (through PTBC Technology Business
Committee)
※ Annual organizing & hosting of“InterBiz Bio-Partnering & Investment Forum”
▶ Establishment & Management of subsidiary associations
※ Association of API Development Professionals
※ Association of Regulatory Affairs Professionals
※ Association of Pharmaceutical Research Analysis
※ Association of Computer Aided Drug Design
※ Korea Herbal Medicine Association
▶ State-of-the-art information services & publication of various
kinds of industrial reports
▶ Education and trainning in several fields; R&D, CMC, IP, BD,
Mgmt, RA, Strategy, API, Analysis etc.
▶ Establishment & Management of Korea New Drug Award(KNDA) etc.
Member companies
KDRA member companies, regular and associate, are all leading
and representing the R&D based pharmaceutical & biotech industries
of Korea and have been conducting almost all of research and
development activities in the field of Korean pharmaceutical &
biotech industry. These companies are investing more considerable
R&D expenditure than any other companies existing in the industry
and occupying over 60% of the domestic market.
KDRA member companies have been involving in pioneering
unmet medical needs areas investing over 65% to their annual net
profit with the strong support from the Korean government,
continuous pursuit of R&D productivity & efficiency to overcome the
disadvantageous R&D resources in comparision with the advanced
nations, highly educated & experienced R&D manpower, strong
passion for new drug development, strategic & dynamic nationwide
collaboration network between the industry, academia and public
research orgs. and strong will & vision for global market.
Regular Members
Ahn-gook Pharm Co., Ltd.
ILYANG Pharm. Co., Ltd.
Whanin Pharm Co., Ltd.
DreamPharma Corp.
Institut Pasteur Korea
BCWORLD PHARM
JW Pharmaceutical
YUHAN Corporation
Hanall Biopharma Inc.
Reyon Pharm Co. Ltd.
Bukwang Pharm. Co., Ltd.
Kolon Life Science. Inc.
Yuyu Pharma Inc.
Hanlim Pharm. Co., Ltd.
Sam Chun Dang Pharm.
Co., Ltd.
Chemizon Inc.
Korea United Pharm. Inc.
Thomson Reuters
HUONS Co., Ltd.
Samyang Corporation
CJ Cheiljedang Corp.
KUKJE Pharma. Ind.
Co., Ltd.
Amore PACIFIC Co., Ltd.
ILDONG Pharmaceutical
Co., Ltd.
SK biopharmaceuticals
Co., Ltd.
Daewoong Pharmaceutical
Co., Ltd.
KYONGBO Pharmaceutical
Co., Ltd.
BORYUNG Pharmaceutical
CO., Ltd
JEIL Pharmaceutical
Co., Ltd.
ViroMed Co., Ltd.
Dong-A Pharmaceutical
Co., Ltd.
Myungmoon Pharm.
Co., Ltd.
Celltrion Chemical Research
Institute
Kolmar Korea Co., Ltd.
YD life science company
Dong Wha Pharm. Ind.
Co., Ltd.
Korea Otsuka
Pharmaceutical Co., Ltd.
Chong Kun Dang
Pharmaceutical Corp.
Korean Drug Co., Ltd.
Yung Jin Pharm. Co., Ltd.
Green Cross Corp.
RNL BIO Co., Ltd.
Croen Research
Incorporated
KPX LIFE SCIENCE Co., Ltd.
Korea Institute of
Toxicology
Handok Pharmaceutical.
Co., Ltd.
Samjin Pharm
Deawon Pharm. Co., Ltd
Kwang-dong
Pharmaceutical Co., Ltd.
Hanmi Pham Co Ltd.
Shin Poong Pharmaceutical
Co., Ltd.
Dong Kook Pharmaceutical
Co., Ltd.
LG Life Sciences Ltd.Yung
Jin Pharm. Co., Ltd.
Hyundai Pharm. Ind. Co., Ltd.
SK Chemicals
Associate Members classified by subsidiary associations
Association of API
Development
Professionals
(174 Member companies)
Association of
Regulatory
Affairs Professionals
(130 Member companies)
Korea Herbal
Medicine Association
(70 Member companies)
Associate
Members
classified
by subsidiary
associations
Association of
Pharmaceutical
Research Analysis
(140 Member companies)
Contact
Hun Che Cho, Director, Research & Development Promotion Dept.,
Korea Drug Research Association(KDRA)
121-150, Dangsan-Dong, Yeongdeungpo-Gu,
Seoul, 150-040, Korea
T. 82-2-525-3108
F. 82-2-525-3109
E-mail. hccho@kdra.or.kr URL. http://www.kdra.or.krr
Association of
Computer Aided
Drug Design
(50 Member companies)
Korea Health Industry Development Institute (KHIDI) is a public
organization that consists of a group of experts dealing with various
programs on promoting and developing health industry in Korea,
while helping improve the national healthcare services.
Growing interest in health issues and an aging society have
highlighted the importance of health industry. The government of
Korea has also made a special effort to stimulate health industry by
designating it as one of new growth engines of the country. Today,
health industry is more than mere medical treatments; it has now
become a pivotal business in developing the national economy.
Since its establishment in 1999, KHIDI has been playing a major
role in the industry development as the nation’s only one
organization responsible for fostering health industry. While we have
striven to produce more successful research outcomes by means of
greater investments in Health Technology (HT) R&D, KHIDI also took
the initiative in increasing competitiveness in different areas of health
industry, including pharmaceuticals, medical devices, foods, and
beauty & cosmetics businesses.
What is more, we’
ve been continuously endeavoring to have local
health industries make inroads into a global market. In doing so,
global healthcare business in Korea has grown rapidly, and now we’
re witnessing an enormous growth in the number of foreign patients
visiting Korea. Not only that, a significant number of Korean medical
institutions is now considering overseas hospital planting as the
demand continues to grow.
Organization
KHIDI, as a health industry hub, will spare no effort to advance the
industry as well as to sharpen the industry’
s competitive edge in the
international community. Your continued help and support for the Korean
health industry will serve as a cornerstone for the industry becoming
the nation’
s hope business in the future.
Vision
The Korea Health Industry Development Institute(KHIDI) will contribute
to the improvement of the standard of living for the people and to
the development of national economy, by fostering health industry as
a national core strategic industry in the 21st century.
Bio-health Advanced country
To raise the competitiveness of our health and medical industry to
global standards through implementation of projects for development
of Bio-health industry and improvement of health services.
Advanced countries: G7 in health and medical industry with
pharmaceuticals ranked 7th, medical equipment 5th, food 8th,
cosmetics 7th, 95% of level of medical service technology and etc.
Professional Institution
We are in pursuit of establishing a professional institution with
superior domestic health services through customized supports
(customer satisfaction), maximized organizational effectiveness
(managerial innovation) and human resources armed with
professional knowledge.
Service
Development Strategy Office
Food and drug industry group
1. Planning new strategic projects, setting up development
strategy, setting up mid to long term management goal
2. Human resources (human resources policy, human management,
employee evaluation, employee education, employee adjustment
in each development)
3. Minister performance contract (administer performance contract)
4. Labor affairs
1. BT policy research, fostering methods of BT, system research of
pharmaceuticals, cosmetics, and oriental industry
2. Research on policies and systems at home and abroad
3. Research and analysis of BT policy trends, support to build
Osong Bio Health Technopolis
4. Research on medical device industry policy, fostering methods
of the medical device industry and system research
5. Research and analysis of policy, system and trends at home
and abroad
6. Policy and system research of food hygiene and safety trends
7. Research and analysis of policy, system and trends at home and
abroad
8. Technical support to improve hygiene control and safety of
companies
9. Provincial food industry development support
10. Evaluation of functionality, effectiveness and standards
11. GH evaluation support
12. Activation of Korean medical devices
Management Support office
1. Set up business plan by year and budget planning
2. Business adjustment
3. Management rationalization
4. Support for Board of Directors
5. Manage Articles of Incorporation and other regulations
6. Manage management disclosures and books/publications
7. Supervise parliamentary affairs and national assembly inspection
8. Management evaluation and innovation (including innovation
level diagnosis)
9. Customer satisfaction
10. BSC planning and operation
11. Education for industrial professionals
12. Public health industry forum
13. Internal and external promotion, events and external cooperation
Industrial Statistics Office
1. Industrial supervision (comprehensive plan for development strategy
of public health industry, FTA impact assessment, fostering laws,
etc.) *Supervise industry-specific policy and system development:
FTA, industry fostering TF operation, industry analysis, white paper,
report, etc.
2. Statistical DB deployment, development of statistics indicators,
implementation and operation of statistical system *Drugs, medical
devices, foods (production basis), cosmetics
Medical Service Industry Group
1 . Research medical service industry policy (including oriental
medical service), fostering methods, and system research
2. Trend analysis of medical service industry
3. Accounting principle operation support
4. Medical hospital consulting, Medical institution management
rationalization including management support for small hospitals
5. Management support for leveraged hospitals
6. Survey on management of medical institutions (hospital management
analysis, etc.)
7. Medical resources
8. Medical institution evaluation
9. Provincial medical center evaluation
10. Evaluation of industrial insurance hospitals and oriental medical
hospitals
Global Healthcare Business Center
1. Technical evaluation, brokerage of technical support at home
and abroad (technical loan support, technology business
network, bio-Korea included)
2. Technical export and import
3. Support for venture companies
4. Support for licenses, permits and patent
5. GHHT certification
6. Support for overseas marketing (expos, provision of import and
export information)
7. Support for overseas license, permission and authentication
8. Attraction of foreign patients and advance of medical institutions
to overseas markets
9. Affairs on overseas residents including the operation of export
support center
10. International trade (assistance for bilateral and multilateral
international trade negotiation)
11. International cooperation (Global alliance, cooperation with
international organization, international cooperation for public
health and medical technology)
Senior Products industrial center
1. Provide information on policy development to foster the senior
product industry
2. Senior products industrial center (designate good products)
3. Lay a foundation to foster the nursing service industry
Nutritional policy center
1. Support for the development of nutritional policy
2. Support and operation of nutrition management for pregnant
women, infants and babies
3. Nutritional research, nutritional DB deployment, provision of
nutritional information
HACCP support group
1. Designation and evaluation of HACCP, evaluation-related DB
deployment and operation
2. Support for the operation of designated business entities, substandard business entities and follow-up management
3. HACCP on-site technical support, technical consultation,
education support
Public health and medical business group
1. Support for modernization of facilities and equipment in public
hospitals
2. Set up, execution, evaluation and assistance for public health
and medical planning
3. Policy development of public hospitals and reinforcement of
functions of state-run university hospitals
4. Modernization of facilities and equipment in public health
centers located in rural areas
5. Set-up of provincial health and medical plan and execution
result evaluation
6. Education for professionals in the public health area
7. IP control
8. Technical service contract, royalty control
9. Convention, settlement, call center management
10. Project expense and operating cost control
11. R&D information system, comprehensive management system
(electronic convention, statistics, DB management)
12. Project announcement and explanatory meeting
13. Business support for national assembly inspection and audits
related to R&D, management evaluation, customer satisfaction
control, budgeting
Disease research group
1. Supervise evaluation system, evaluation report and schedule
2. Responsible for R&D business plan (set u annual action plans)
3. Technical trend research and analysis (demand research,
technical level investigation, technical forecast, overseas R&D
trends)
4. Responsible for mid to long term health and medical technology
strategy planning (brokering clinical research, rare diseases,
innovative research hospitals, etc.)
5. Set up implementation plan of disease research, research demand
analysis, research planning including mid to long term technical
strategy planning
6. Improve evaluation system templates in the disease research
area
7. Issue evaluation of disease research (selection, annual, interim and
final), issue control during research period, performance report
evaluation
8. Professional committee related to disease research
R&D support office
New technology development group
1. Overall support and adjustment of research and development projects
2. Issues on establishment and revision of rules and guidelines of
R&D projects
3. Health and medical technical policy review committee, R&D
council in service
4. R&D project performance management analysis and evaluation,
performance-tracking management
5. Research, analysis and evaluation
6. Performance presentation and promotion (Technical fair and PR
for the general public)
(New drugs, bio, medical devices, foods, cosmetics, oriental
medicine, etc.)
1. Set up action plan in new drug development area, book-building,
research plan like mid to long term strategy establishment
2. Improve evaluation system, and form in the new technical
development
3. Define issues in the new technical development area (Selection,
annual, interim, final), issue management during the research
period, performance result evaluation
4. Form a professional committee for new technical development
Contact
Jung, Yun-Taek, Team Head, Department of Health Industry Promotion,
Pharma advancement Team, Korea Health Industry Development Institute(KHIDI)
187 Osongsaengmyeong2(i)-ro, Gangoe-myeon, Cheongwon-gun,
Chungcheongbukdo, 363-700 Korea
T. 82-43-713-8368
E-mail. jytaek@khidi.or.kr
F. 82-43-713-8908
URL. http://www.khidi.or.kr
Global Pharmaceutical Industry in its operation and innovation activities
is now facing serious challenges resulted by mega trends in healthcare
paradigm. Global pharmaceutical industry including Korean pharmaceutical
industry is trying to approach the smart strategies to avoid the slow-down
in productivity, cut-down of innovation value, reinforcement of regulation,
lack of real innovation, patent expiration etc through making value-based
innovation and level-up of innovation meeting the market needs from the
population and government.
To accelerate the innovation activities and meet the various kinds of call
for innovative therapeutic agents having better therapeutic benefits from
patients, the government, health insurance agency and market, Korean
R&D-based pharmaceutical companies have been involving in pioneering
unmet medical needs areas investing over 65% to their annual net profit
with the strong support from the Korean government.
Korean R&D-based pharmaceutical companies have continuously been
pursuing R&D productivity & effectiveness to overcome the
disadvantageous R&D resources in comparision with the advanced
nations. The main driving power of the industry is highly educated &
experienced R&D manpower, strong passion for new drug development,
strategic & dynamic nationwide collaboration network between the
industry, academia and public research orgs. and strong will & vision for
global market.
Korea emerging as a hub country in north east Asian area has also
been emerging as a key contributor in global healthcare innovation. During
the past 10 years global pharmaceutical & biotech industries have
witnessed Korea coming up to the global pharmaceutical market as one of
the countries possessing new drug R&D abilities.
Modern pharmaceutical industry in Korea has 110 years of history
initiating at the end of the 1800s, when a first modern pharmaceutical
company began its operation. With the introduction of product patent
system in 1987, Korean pharmaceutical companies initiated full-scale R&D
activities as the last breakthrough to cope with the rapidly changing
pharmaceutical environment, and spared no efforts to expedite their R&D
activities towards the development of new drugs for around 30 years with
a firm conviction for being major contributor to the global pharmaceutical
innovation for the healthy life of the population.
Although with a comparatively small market size, US$ 14billion in
production occupying 1.9% of global market at present, Korean market is
expected to grow up unceassingly with rapid annual growth rate of 10% in
domestic market surpassing the world average 6-7%. To overcome the
small market size in comparision with bigger market in US, EU etc, the
Korean pharmaceutical industry has been accelerating their innovation
activities in new drug R&D to early entering the overseas market.
According to the recent analysis data by Korea Health Industry
Development Institute(KHIDI), major 44 R&D-Based Korean pharmaceutical
companies recently designated to be innovative pharmaceutical
companies by the Ministry of Health & Welfare of Korea will increase R&D
investment from 1,272,300 KRW million to 3,879,800 KRW million by 2020.
As for the Korean pharmaceutical industry, during the past 30 years
there has been marvelous advancement in new drug research and
development; market-launched 32 new drugs approved by Korean
regulatory agency(KFDA), around 15 IND-approved(by US FDA, EMA) new
drug candidates, 86 out-licenced(to 26 countries) new drug candidates &
technologies, 150 or so finished drugs & APIs already launched in
overseas market including US and EU, 650 or so leads or druggable
candidates existing in Korean pharmas' labs etc.
Korean pharmaceutical industry owes these successful innovation
activities and future vision to not only their own strong passion & resolute
R&D investment for growth strategy through innovation in new drug
research and development but also systemic R&D ecosystem surrounding
the industry; optimized R&D environment closely linked to the industry and
strong governmental support.
Accompanied by 150 or so universities and colleges having strong
needs for R&D co-works and technology commercialization with the
industry with their excellent IP assets in early stage research areas, 6
major public research institutes(Korea Institute of Science & Technology,
Korea Research Institute of Bioscience & Biotechnology, Korea Research
Institute of Chemical Technology, Korea Basic Science Institute, Institute
Pasteur Korea, Korea Institute of Toxicology) having excellent research
abilities in basic & applied science and superior research infrastructure
and 15 preclinical trial organizations & 142 clinical trial facilities, most of the
R&D based Korean pharmaceutical companies have been pioneering the
future with new drug R&D.
In this new drug R&D ecosystem well designed & functionally organized
in the direction of concentrating to the acceleration of the innovation
activities of Korean pharmaceutical industry there also exist strong support
from the Korean government in several areas; establishment of the Act for
supporting & raising pharmaceutical industry, a special law enacted in
2011 to prepare important basis to support & accelerate the industrial
growth through reinforcement of innovation, vast amount of R&D funding
and preparation of important R&D infrastructures etc.
Before the legislation of the Act for supporting & raising pharmaceutical
industry, the Korean Government, keeping pace with the efforts of the
industry, has chosen the pharmaceutical & biotech industry as one of the
10 fastest growing industry sectors in parallel with IT sector and has
planned mid-and long-term fostering programs.
Recently the Korean government(the Ministry of Health & Welfare) in
accordance with the provisions of the Act for supporting & raising
pharmaceutical industry has designated 44 Korean pharmaceutical
companies including 1 foreign-based company as Korea innovative
pharmaceutical company to provide special benefits in tax reduction &
exemption, preferential governmental research funding, postponement of
drug price cutting-down etc. in order to promote R&D investment and
support sustainable growth. More than anything else this means that the
government guide and urge the industry to be innovative to become the
leading industry in global market through the designation of innovative
pharmaceutical companies to be appealled to the whole pharmaceutical
industry as role-model.
Korean government has also been supporting tremendous
governmental fund to new drug R&D and biotechnology areas since 1987
and recently it amount to around 2.0 US B$ in a year as of 2010
coincidently establishing Korea Drug Development Fund, National
OncoVenture and Hitech Medical Clusters in Osong & Daegu-Gyeongbuk
as important national new drug R&D infrastructures.
Korean Pharmaceutical Market
Trade Balance and Korean Pharmaceutical Market Status
(Unit, KRW 100Million)
Classification
2008
2009
2010
Production Amount
138,938
147,886
157,098
Export
12,666
17,872
19,833
Import
45,582
52,193
54,172
Balance of Trade
-32,916
-34,321
-34,339
Market Size
171,854
182,206
191,437
Market Opportunity Ranking of Asian Territories
※ Source : Annual Food & Drug Statistics Report. Korea Food & Drug Administration. 2011
Pharmaceutical Companies & Annual Pharmaceutical
Production in Korea(Unit, KRW Billion)
Year
Companies
Items
Production(Value)
2005
546
23,374
10,599
2006
570
25,589
11,472
2007
589
26,067
12,598
2008
587
25,118
13,894
2009
580
25,362
14,789
2010
593
25,534
15,710
※ Source : The Changing dynamics of pharma outsourcing in Asia, PWC, Sep.2008
Ranking of Asian Territories across all factors
※ Source : Annual Food & Drug Statistics Report. Korea Food & Drug Administration. 2011
Current Status of Employment in Korean Pharmaceutical Industry
Classification
2008
2009
No. of Employees
%
2010
No. of Employees
% No. of Employees
%
R&D
7,801
10.3
8,640
10.6
8,699
Production
23,212
30.8
24,354
30.0
24,050
11.3
31.1
Sales & Mkt
26,721
35.4
27,520
33.9
26,626
34.4
Administrative
14,009
18.6
15,924
19.6
14,792
19.1
Others
3,663
4.9
4,766
5.9
3,147
4.1
Total
75,406
100
81,204
100
77,314
100
※ Source : Korea Food & Drug Administration. 2011
Number of Pharmaceutical Manufacturers in Compliance
with GMP(2010)
Total
KGMP
BGMP
383
247
136
※ Source : The Changing dynamics of pharma outsourcing in Asia, PWC, Sep.2008
Wider Risk Ranking of Asian Countries
※ Source : Annual Food & Drug Statistics Report. Korea Food & Drug Administration. 2011
Number of Approved Clinical Trial & Non-Clinical Trial Facilities
Total
Clinical
Non-Clinical
157
142
15
※ Source : Annual Food & Drug Statistics Report. Korea Food & Drug Administration. 2011
Number of Approved Clinical Trials for Drug Products
Classification
Approved
Local
Multinational
2008
400
184
216
2009
400
198
202
2010
439
229
210
※ Source : Annual Food & Drug Statistics Report. Korea Food & Drug Administration. 2011
※ Source : The Changing dynamics of pharma outsourcing in Asia, PWC, Sep.2008
R&D
New Drug Approval Status of Major Korean Pharmaceutical
Companies by Therapeutic Category
※ Source : KDRA Survey over 37 Leading Pharmaceutical companies in 2012
New Drug R&D Pipelines of Major Korean Pharmaceutical
Companies by Active Ingredient
※ Source : KDRA Survey over 37 Leading Pharmaceutical companies in 2012
New Drug R&D Pipelines of Major Korean Pharmaceutical
Companies by R&D Stage
※ Source : KDRA Survey over 37 Leading Pharmaceutical companies in 2012
New Drug R&D Pipelines of Major Korean Pharmaceutical
Companies by Therapeutic Category
※ Source : KDRA Survey over 37 Leading Pharmaceutical companies in 2012
New drug R&D ecosystem of Korean Pharmaceutical Industry
R&D Investment
R&D Investment to Sales Revenue of Major Korean
Pharmaceutical Companies
※ Source : KDRA Survey over 37 Leading Pharmaceutical companies in 2012
R&D Investment Plan(2012-2020) of 44 Innovative Korean
Pharmaceutical Companies
※ Source : KHIDI Survey over 44 Innovative Korean Pharmaceutical companies in 2012
Korean Regulatory & Healthcare Syetem
R&D Investment to Net Profit of Major
Korean Pharmaceutical Companies
※Source : KDRA Survey over Leading Pharmaceutical companies in 2010
Results from Innovation Activities Highlighted
Market-launched 32 new drugs approved by Korean regulatory agency(KFDA)
15 IND-approved(by US FDA, EMA) new drug candidates
86 out-licenced(to 26 countries) new drug candidates & technologies
150 or so finished drugs & APIs already launched in overseas market including US and EU
8 Overseas Regulators Approved & Market Launched New Drugs already launched in
U.S. E.U etc.
650 or so leads or druggable candidates existing in Korean pharmas' labs etc
Key Factors in Korean Pharmaceutical Innovation
Resolute R&D investment by pharmaceutical industry sector with major R&D intensive
companies investing up to 90% to net profit
Continuous pursuit of R&D productivity & efficiency to overcome the insufficient R&D
resources & infrastructures in comparision with the advanced nations
Highly Educated & Experienced R&D Manpower
Strong Passion for New Drug Development in spite of insufficient R&D
Strategic & Dynamic Nationwide Collaboration Network between the industry, academia
and public research orgs.
Strong Government Support & R&D Programs since 1982
Strong will & vision for pioneering the real innovation & entering in Global Market