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SK bioscience

SK bioscience is growing into a domestic and global vaccine developer by
continuously making investments and establishing infrastructure for vaccine development.

History

2018 - 2022
Into the global healthcare market
  • 2022
  • Achieved adolescent authorization of 'Nuvaxovid' by KMFDS (Novavax, KMFDS)
  • Submitted CMA to the EMA (SKYCovion)
  • Submitted CMA to the MHRA (SKYCovion)
  • Agreement to Manufacture COVID-19 Vaccine Containing Omicron Variant (Novavax)
  • Achieved BLA of SKYCovione (KMFDS)
  • Heid SK bioscience Global Forum
  • Published first ESG report
  • Achieved BLA of SKYTyphoid for export
  • Achieved Turkish GMP Certification (TITCK)
  • Agreed SKYvaricella distribution(PAHO)
  • Signed Advance Purchase Agreement of GBP510(KDCA)
  • Obtained additional EU-GMP Certification for COVID-19 Vaccine Facilities
  • Authorized ‘Nuvaxovid’ by KMFDS (Novavax, KMFDS)
  • 2021
  • Earned the highest sales and operating profit
  • Funded to develop a vaccine candidate against sarbecovirus (CEPI)
  • Established ‘Park Mahnhoon Award’ (IVI)
  • Submitted BLA submission for approval of the COVID-19 vaccine candidate, ‘NVX-CoV2373’ (Novavax, KMFDS)
  • Signed an agreement to extend capacity reservations for manufacturing COVID-19 vaccines (CEPI)
  • Started phase 3 trial for COVID-19 vaccine candidate 'GBP510'
  • MOU for expansion of factories and site (North Gyeongsang Province, Andong city)
  • Secured funding for phase 3 clinical trial of COVID-19 vaccine candidate 'GBP510' (CEPI)
  • Obtained EU-GMP Certification for COVID-19 Vaccine Facilities
  • New listed on KOSPI(Korea Composite Stock Price Index)
  • Funded to develop a vaccine candidate against COVID-19 (SARS-CoV-2) variants (CEPI)
  • Signed licensing & purchase agreement for Novavax’s COVID-19 vaccine candidate (Novavax, KDCA)
  • GSK ‘GBP510’, a COVID-19 vaccine candidate, begins clinical trials for immunosuppressants
  • Applied for permission to export typhoid vaccines
    (IVI, Bill & Melinda Gates Foundation)
  • 2020
  • Started clinical trial for in-house produced COVID-19 vaccine (GBP510, NBP2001)
  • Announced as WAVE2 by CEPI with GBP510 (COVID-19 vaccine)
  • Exported SKY Varicella Inj. to Turkey
  • Signed CDMO agreement with Novavax for COVID-19 vaccine
  • Signed CMO agreement with AstraZeneca for the consigned production of COVID-19 vaccine
  • Signed capacity reservation with CEPI for COVID-19 vaccine
  • Secured funding for development of COVID-19 from Bill & Melinda Gates foundation
  • Selected for national projects for COVID-19 vaccine
  • Began independent development of COVID-19 vaccine
  • Started phase 2 clinical trial for the next-generation pneumococcal conjugate vaccine co-developed with Sanofi Pasteur
  • 2019
  • Gained WHO PQ for SKY Cellflu prefilled syringe/SKY Cellflu Quadrivalent prefilled syringe (world’s first for cell-cultured influenza vaccine)
  • Gained WHO PQ for SKY Varicella Inj. as world’s second
  • Exports influenza vaccine, ‘SKYCellflu’, to Asian countries
  • 2018
  • MOU with Gyeonggi-bukdo and Andong-si for expansion of L HOUSE (Andong vaccine plant)
  • SK bioscience launched (Spun off from the vaccine business sector of SK chemical)
  • Signed agreement with Sanofi Pasteur to license out cell-culture technology for producing cell culture-derived influenza vaccines
  • Launched SKY Varicella Inj.
SK L HOUSE image
2015 - 2017
The pinnacle of in-house technology
  • 2017
  • Launched Sky Zoster Inj., world’s second shingles vaccine
  • Urgent supply of ‘SKYCellflu Quadrivalent’ Influenza Vaccine to Flu-ridden Myanmar
  • Signed an agreement with international organization PATH to develop and produce pediatric enteritis vaccine for developing countries
  • 2016
  • Selected health and safety management indicators (L House [Andong Vaccine Plant]); received OHSAS18001, KOSHA18001 certification
  • Launched SKYCellflu Quadrivalent, world’s first quadrivalent cell culture-derived influenza vaccine
  • Gained approval for SKYPNEUMO, the first domestically produced PCV13 vaccine
  • 2015
  • Launched SKYCellflu, Korea’s first trivalent cell culture-derived influenza vaccine
Sky Zoster Inj image
2012 - 2014
Growth takes a leap forward
  • 2014
  • Established strategic partnership with Sanofi Pasteur for co-development of next-generation pneumococcal conjugate vaccine
  • Received KGMP certification for L HOUSE (Andong Vaccine Plant)
  • 2013
  • Received LEED GOLD certification for L HOUSE (Andong Vaccine Plant)
  • Established partnership with IVI (International Vaccine Institute) to collaborate on the development of a new typhoid conjugate vaccine
  • 2012
  • Completion of L HOUSE (Andong Vaccine Plant)
Image of strategic partnership established with Sanofi Pasteur
2001 - 2009
Into the domestic healthcare market
  • 2005
  • Established vaccine R&D center
  • 2001
  • Acquired Dongshin Pharm (vaccines, blood products)
Electron micrograph image