● SK chemicals Acquired Marketing Permission of the World’s First Quadrivalent Cell Culture
   Flu Vaccine ’SKYCellflu Quadrivalent’

- SK chemicals, Acquired permission of the world’s first quadrivalent cell culture flu vaccine
- Result of R&D concentrated investment and public-private partnership
- Expected to be a bridgehead of market invasion.



SK chemicals (CEO Park Mahn Hoon) said on the 24th that the quadrivalent cell culture flu vaccine ‘SKYCellflu Quadrivalent’ has got marketing permission from Food and Drug Administration of Korea. It is the first marketing permission of quadrivalent cell culture flu vaccine in the world.

Permitted Products have characteristics that graft next generation technologies of flu vaccine like ‘Quadrivalent’ and ‘Cell culture’.

The quadrivalent vaccine that add B-type virus No. 1 to existing trivalent can prevent all flu viruses of 4 types like A-type No. 2 and B-type No. 2 that common in human. The World Health Organization (WHO) and the European Medicine Agency (EMA) have advised vaccination of quadrivalent vaccine for efficient prevention of flu’s danger.

The cell culture method produces vaccine not using egg unlike existing fertile egg method, but through high-tech sterile culture. Therefore, it isn’t necessary injection of antibiotics or preservatives, and it can be vaccinated in case that has egg allergic. Also, it can react quickly to flu strain like swine flu because it has a short production period in half than fertile egg method.

‘SKYCellflu Quadrivalent’ that graft quadrivalent and cell culture technology can start vaccination from the next year by this marketing permission.

SK chemicals has a plan that carry momentum from the trivalent cell culture flu vaccine that be released this year and arrive safe in the domestic market to the quadrivalent and make inroads in the global market.

The trivalent cell culture flu vaccine is verified effect and safety, and have passed accumulated order·sale amounts 3 million dose (1 dose = vaccination 1 time) in about 2 months from releasing.

The CEO of SK chemicals, Park Mahn Hoon, said “We will inform the first vaccine that developed entirely with domestic technology, and rank beside advanced medicine market as Europe and United States.” and “From now, we will develop various premium vaccines and contribute to establish sovereignty of vaccine.”

SK chemicals got into stride vaccine research and development as next generation growth power from 2008, and invested budget of approximately 400 billion won to R&D and construction of infrastructure, and completed the L HOUSE, vaccine factory of world class level. The L HOUSE possesses production facility and foundation technology as △Cell Culture, △Germ Culture, △Gene Recombination and △Protein Connection Vaccine, and can produce vaccines of various types.

SK chemicals which was trying hard to research and develop for cell culture IV as a flu vaccine cooperating with Ministry of Health and Welfare, Korean Food and Drugs Administration, Ministry of Commerce, Industry and Energy, Gyeongsangbuk-do Province, Andong-si, government ministry and local government. They establish a bridgehead base as a global vaccine specialized company.



[Photo]
Andong L House, produce the world’s first quadrivalent cell culture flu vaccine



[Fertile chicken eggs and cell culture]

-. The flu vaccine currently distributed in a domestic market is fertile chicken eggs system and cell culture system.
-. Fertile chicken eggs system was developed in 1940, producing a vaccine using eggs.
-. fertile chicken eggs system needs one fertile chicken egg to produce 1 doze (for one person) and
   the disposal of waste was issued.
-. SK chemicals and Korea Green Cross Corporation conducted a cell culture flu vaccine and they are in clinical 3 phase
   last November
-. The cell culture flu vaccine is considered as next generation technology overseas.
-. A billion dollar was supported for flu vaccine development based on cell culture by American Ministry of Health and
   Welfare in 2006.
-. Flu vaccine development facility was established with Novartis company supporting 4 billion and 187 million dollars
   in 2009.
-. Cell culture flu vaccine of Novartis was approved by American FDA on November, 2012. first time in the world.



[4A Flu vaccine]

-. The virus cause cold is divided into A, B, C type.
-. Type A, class II and type B, class B are popular among people.
-. Till this year, flu vaccine III is mainly provided.
-. Among type A, class II (A/H1N1, A/H3N2), type B, class II (B-Victoria, B-Yamagata), the vaccine 3 which is
   combined by type A, class 2 and type B class 1.
-. World Health Organization predicts a flu virus III which will be popular in that year every February.
-. The manufactures in every country, they produce virus including 3 kinds of virus that year and provide at
   vaccination season.
-. Therese days, mismatch of III vaccine occurred a lot.
-. Mismatch means the virus which WHO predicts doesn’t meet an actual widespread flu that year.
-. Last 10 years, WHO predicted type B virus was failed around at 50%.
-. Class IV flu vaccine include type A, class II and type B, class II.
-. This year Peullua Liks Tetra” class Iv flu vaccine developed by multinational drug maker was introduced in
   a domestic market.
-. Fertile chicken eggs system of Korean Food and Drugs Administration was allowed domestic marketing on
   26th of November.
-. SK chemicals cell culture IV approved by Korean Food and Drugs Administration.