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No. 6 Global Clinical Trial Leader Boasting Global Clinical Trial and Regulatory Environment Close
No. 6 Global Clinical Trial Leader Boasting Global Clinical Trial and Regulatory Environment

The Ministry of Food and Drug Safety analyzed the data on the clinical trials registration system of the US National Institutes of Health (ClinicalTrials.gov). According to the analysis, Korea’s industry-led clinical trials ranked no. 6 in 2020, compared to no. 8 in 2019. Its multinational clinical trial ranking also rose from no. 12 in 2019 to no. 10 in 2020. Seoul, in particular, has continued to rank first in global clinical trial city rankings since 2017.

The number of clinical trials on pharmaceuticals in Korea rose by 12% year-on-year in 2020, showing a steady increase, thanks to excellent infrastructure in Korea. Korea offers a prompt application and approval period (30 days), efficient IRB composition, and over 30 proven clinical trial hospitals and 170 clinical trial centers (CTCs) that have large and diverse patient pools.

Korea joined the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014 and the (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2016, being recognized as a developed country in terms of pharmaceuticals regulation. In May 2019, Korea became the seventh country to be listed on the EU Whitelist. Korea is now exempt from the GMP written confirmation of drug substances, which was required for exports to the EU.
- Clinical trial market share by city 'Seoul' 1st
- Multinational clinical trials 'Korea' 10th
- Clinical trial hospitals and accredited clinical laboratory 200 units
- Clinical trial application and approval period 30 days
※ Source: Ministry of Food and Drug Safety/Korea Biotechnology Association

"EU White List (Countries Exempted from the GMP Written Confirmation)"
World's 7th country to be listed on the EU Whitelist

1. Switzerland Listed in November : 2012.11

3. Japan Listed in November : 2013.6

4. US Listed in November : 2013.6

5. Israel Listed in November : 2015.7

6. Brazil Listed in November :2015.7

7. Korea Listed in November : 2019.5
※ Source: Ministry of Food and Drug Safety
World-Class Biopharmaceutical Consignment Production Facility Open
World-Class Biopharmaceutical Consignment Production Facility

Korea is raising its status as a base for global biopharmaceutical consignment production. Samsung Biologics is building its fourth plant with a capacity of 256,000 liters in addition to the existing 364,000 liters of production capacity. Celltrion is also planning to build its third plant with an additional 60,000-liter capacity in addition to the existing 190,000-liter production capacity.

Amid the COVID-19 pandemic, consignment production cooperation between Korean companies and global vaccine companies is underway. SK Bioscience is promoting consignment production of AstraZeneca and Novavax, while Samsung Biologics is consigned to produce the Moderna vaccine.
"Consignment Production Capacity of Korean Biopharmaceuticals"
- Samsung Biologics
  
  Total capacity - 364,000 liters+
  
  Production per plant
  
  plant 1: 30,000 liters
  
  plant 2: 154,000 liters
  
  plant 3: 180,000 liters
  
  plant 4: 256,000 liters (In progress)
- CELLTRION
  
  Total capacity - 190,000 liters+
  
  Production per plant
  
  plant 1: 100,000 liters
  
  plant 2: 90,000 liters
  
  plant 3: 60,000 liters (In progress)
  
  Three Celltrion plants: 60,000 liters (Total production 190,000 → 250,000 liters)
Growth of the Entire Bio Industry Focused on Finished Pharmaceutical Products Open

Growth of the Entire Bio Industry Focused on Finished Pharmaceutical Products

Domestic pharmaceutical production in 2020 was KRW 24.5 trillion, up 10.1% compared to the previous year, according to the Ministry of Food and Drug Safety. The industry has shown an average annual growth rate of 6.9% over the past five years. Finished pharmaceuticals accounted for 85.6% and raw materials accounted for 14.4% of total pharmaceutical production.

(Unit : KRW trillion, %, USD 100 million, $)

Bio Industry Trend Category, Years

※ Source: 2018 Domestic Bio Industry Survey

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R&D and Government Support for Advanced Biopharmaceuticals Open

R&D and Government Support for Advanced Biopharmaceuticals

The biopharmaceutical market is a growth engine industry in Korea that is growing at an average annual rate of 13%, thanks to exports of biosimilar products.

Korea has shown outstanding R&D on biosimilar. As of September 2021, eight out of 31 biosimilars products approved by the US FDA were developed in Korea, demonstrating the country’s rapid R&D capabilities.

The Korean government has selected the bio industry as one of the three key industries for national innovative growth and prepared supportive policies for industries and companies with a K-Global Vaccine Hub Strategy for the sake of COVID-19 responses and treatment. Foreign investment in medicine and bio that have reached certain requirements will be exempted from income taxes, acquisition taxes, and property taxes, according to the Restriction of Special Taxation Act. Capital goods designated in the decree of the same act will be exempted from duties, individual consumption taxes, and value-added taxes. From 2022, the Advanced Investment District Designation and the Improved Cash Grant System will be implemented to expand the benefits for foreign-invested companies.

Meanwhile, the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products has been in effect since September 2020. Advanced biological products refer to biopharmaceuticals manufactured from living cells, tissues, or genes, and include cell therapy, gene therapy, and tissue engineering products. A rational approval review system has been established to match the characteristics of advanced biopharmaceuticals that are different from existing synthetic drugs, such as manufacturing and quality control standards.

Global Pharmaceutical Companies Conduct More Clinical Studies and Joint R&D in Korea Open

Global Pharmaceutical Companies Conduct More Clinical Studies and Joint R&D in Korea

The total R&D cost invested by 35 global companies in 2019 was approximately USD 400 million (KRW 483.7 billion), according to the Korea Research-based Pharma Industry Association, these companies conducted 1,536 clinical studies in Korea in 2019 alone.

Global pharmaceutical companies share their experiences and cooperate with Korean pharmaceutical companies to enter overseas markets.

"Joint Overseas Expansion Cases of Multinational and Korean
												Pharmaceutical Companies"

Joint Overseas Expansion Cases of Multinational and Korean Pharmaceutical Companies Foreign-invested Companies, Korean Companies/Organization, Cooperation
Foreign-invested Companies	Korean Companies/Organization	Cooperation
Abbott	Requesting companies	Regular training on the latest global clinical and licensing/regulatory trends
Abbvie	Donga ST	Joint research on immuno-oncology drug MerTK inhibitor
Janssen	Yuhan	Joint development and contract of commercialization and technology export of Lazertinib, a lung cancer treatment
MSD	Samsung Bioepis	Cooperate for global commercialization of multiple biosimilars
	Donga ST	Joint overseas expansion of Tedizolid, a new superbacterial antibiotic
	Hanmi Pharm	R&D investment and exports of Cozaar XQ, a hypertension treatment, to 50 countries
	Seoul Bio Hub	Opened MSD Innovation Partnering Office (March 2020) and support Korean companies’ global expansion
Zuellig Pharma	Boryung Pharmaceutical	Exclusive license agreement in 13 Southeast Asian countries for Kanarb and Ducarb

※ Source: Korea Research-based Pharma Industry Association 2020 Annual Report

Global pharmaceutical companies are conducting various new drug development research together with domestic pharmaceutical companies, medical institutions, and research institutes.

"Joint R&D Cases of Multinational Pharmaceutical and
												Korean Companies"

Joint R&D Cases of Multinational Pharmaceutical and Korean Companies Foreign-invested Companies, Korean Companies/Organization, Cooperation
Foreign-invested Companies	Korean Companies/Organization	Cooperation
AstraZeneca	Donga ST	Joint research on three leading substances for immuno-oncology
Bayer	Vital Smith, Sky Labs, etc	Launched Grants4Apps Korea, a Korean version of Bayer’s open innovation program
BMS	Samsung Biologics	Concluded a production contract for a new commercial bio-antibody drug
BMS	-	Launched Korea Open Innovation to find domestic partners
GSK	Major Korean research institutes/td>	Joint R&D on next-generation anti-cancer drugs, first trial in patient research on immuno-oncology drug candidates
Leo Pharma	-	Launched LEO Open Innovation Lab program, a skin disease research support program
Lilly	Korea Research Institute of Chemical Technology	Signed an open innovation drug development partnership
MSD	Pan-government New Drug Development Project Team	Joint R&D on anti-cancer drugs with various Korean bio ventures, such as Genexine, Medpacto, Parmepsin, and NKMAX
Novartis	Seoul Bio Hub	Operate Novartis Korea Innovation Partnering Office for cooperation with Korea
Novartis	Catholic Medical Center	Signed an MOU for research cooperation for new drug development using health and medical data and digital technology (April 2020)
Pfizer	-	INSPIRE Program (2012-present)
Sanofi-Aventis	-	Promote collaboration with promising bio-startups in Korea to develop next-generation anti-cancer drugs
Sanofi-Pasteur	SK Bioscience	Global joint research on next-generation pneumococcal conjugate vaccine

※ Source: Korea Research-based Pharma Industry Association 2020 Annual Report

Bio Clusters by Region Open
Bio Clusters by Region

Bio-related clusters have been established throughout Korea. A number of clusters specializing in pharmaceuticals are located in Osong, Daegu, Incheon, and Hwasun. A bio cluster is a close network of universities, companies, hospitals, and research institutes based in specific region. If foreign pharmaceutical companies entering Korea are located in such areas, various incentives, such as tax credits, will be provided, and they can also network with related universities, companies, hospitals, and research institutes.

"Bio Clusters in Korea"
[L] Local government / [P] Private enterprise / [G] Government
- Seoul Heungneung (L): Startup incubation and commercialization support hub
- Gyeonggi (L, P): Enterprise-oriented, enterprise support organizations, infrastructure and services (Hyangnam Pharmaceutical Complex, Gwanggyo/Pangyo Techno Valley)
- Incheon Songdo (L, P): Biopharmaceutical production
- Chuncheon (L): Natural products, pharmaceuticals, health supplements, cosmetics companies
- Biopharmaceutical production(G): Bioclinical & non-clinical
- Wonju (L, P): Specialized medical device industry
- Seosan (L): Greenbio convergence
- Jecheon (L): Oriental medicine bio
- Daejeon Daedeok (R&D special zone) (G): Venture companies oriented, R&D oriented
- Chungju (L): Diabetes bio
- Okcheon(L): Medical equipment
- Gyeongbuk Andong (L): Vaccine bio
- Daegu Gyeongbuk (Advanced Medical Complex) (G): Chemical medicines, medical industry
- Jeonbuk Iksan(L): Food microorganisms
- Gimhae (Biomedical and Medical Equipment Gangso Special Zone)(L): Biomedical life, medical devices, electronic medicine
- Hwasun (L): Biomedical
- Jinju (L): Biological industry
- Jeju (L): Natural beauty products, health, water industry
※ Source: Ministry of Health and Welfare, local governments
※ Data cooperation: Korea Biotechnology Industry Organization

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Medical/Healthcare PM

JEONG DA HEE New Industry Promotion Team

T.+82-2-3460-7865

Recommendation on Locations

BEST1

[Incheon Metropolitan City Michuhol-gu]

Incheon General Industrial Complex

Designated area(m2) : 1,136,269
Management : Incheon Metropolitan City Corporation
Nearby Railway : Bupyeong Station (7km)
Nearby Airport : Gimpo International Airport (29km)

BEST2

[Chungcheongbuk-do Cheongju City]

Osong Life Science Complex

Designated area(m2) : 4,833,314
Management : Korea Industrial Complex Corporation
Nearby Railway : Cheongju Station (9km)
Nearby Airport : Cheongju International Airport (21km)

BEST3

[Gyeongsangbuk-do Andong City]

Gyeongbuk Bio 2nd General Industrial Complex

Designated area(m2) : 299,829
Management : Gyeongsangbuk-do Andong City
Nearby Railway : Andong Station (19km)
Nearby Airport : Daegu International Airport (111m)

BEST4

[Gyeongsangbuk-do Andong City]

Gyeongbuk Bio General Industrial Complex

Designated area(m2) : 941,431
Management : Gyeongsangbuk-do Andong City
Nearby Railway : Yecheon Station (15km)
Nearby Airport : Daegu International Airport (111km)

BEST5

[Gyeonggi-do Hwaseong-sity]

Gyeonggi Hwaseong Bio Valley General Industrial Complex

Designated area(m2) : 0
Management : Hwaseong City Corporation
Nearby Railway : Suwon Station (27km)
Nearby Airport : Gimpo International Airport (52.5km)

BEST6

[Jeollabuk-do Iksan City]

Iksan 4th Industrial Complex [formerly: Iksan General Medical Science]

Designated area(m2) : 502,825
Management : Jeollabuk-do Iksan City
Nearby Railway : Hwangdeung Station (4km)
Nearby Airport : Gunsan Airport (47km)

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Pharmaceutical and Bio

"Consignment Production Capacity of Korean Biopharmaceuticals"