History
2018 - 2023
Into the global healthcare market
- 2023
- Granted Emergency Use Listing by the World Health Organization (SKYCovione™)
- Achieved Marketing Auhorization from UK MHRA (SKYCovione™)
- Signed CMO agreement with MSD for Next-Generation Zaire Ebola Vaccine Candidate
- Achieved ISO 27001 Certification
- Received approval of world-first cell culture based quadrivalent influenza vaccine in Chile
- Received biologics license application approval of shingles vaccine in Malaysia
- 2022
- Published first TCFD report
- Received 'Grade A' rating on ESG Evaluation from the Korea Institute of Corporate Governance & Sustainability
- Donated to international Vaccine Institute to support global vaccine R&D
- Signed a MOU to co-develop new vaccine platforms (Hilleman Laboratories)
- Signed agreement to develop mRNA Vaccines (CEPI)
- 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)
- Held SK bioscience Global Forum
- Published first ESG report
- Achieved BLA of SKYTyphoid™ for export
- Achieved Turkish GMP Certification (TITCK)
- Agreed SKY Varicella® 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)
- Phase III trial for COVID-19 vaccine candidate 'GBP510'
- MOU for expansion of factories and site (North Gyeongsang Province, Andong city)
- Secured funding for Phase III 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)
- Initiated clinical trials of 'GBP510'
- Submitted application for export of typhoid vaccine (IVI, Bill & Melinda Gates Foundation)
- 2020
- Initiated clinical trial for COVID-19 vaccine (GBP510, NBP2001)
- Announced as WAVE2 by CEPI with GBP510 (COVID-19 vaccine)
- Exported SKYVaricella® 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 the Bill & Melinda Gates Foundation
- Selected COVID-19 vaccine candidate for national project
- Began independent development of COVID-19 vaccine
- Initiated Phase II clinical trial for the next-generation pneumococcal conjugate vaccine co-developed with Sanofi Pasteur
- 2019
- Gained WHO PQ for SKYCellflu® prefilled syringe/SKYCellflu®Quadrivalent prefilled syringe (world’s first for cell-cultured influenza vaccine)
- Obtained WHO PQ for SKYVaricella® as world’s second
- Intiated export influenza vaccine, SKYCellflu®, to Asian countries
- 2018
- MOU with North Gyeonggi province and Andong city for expansion of L HOUSE (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-based influenza vaccines
- Launched SKY Varicella®
2015 - 2017
The pinnacle of in-house technology
- 2017
- Launched SKYZoster® Inj., world’s second shingles vaccine
- Supply of SKYCellflu®Quadrivalent to 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 [Vaccine Plant]); received OHSAS18001, KOSHA18001 certification
- Launched SKYCellflu® Quadrivalent, world’s first quadrivalent cell culture-based influenza vaccine
- Obtained approval for SKYPneumo®, the first domestically produced PCV13 vaccine
- 2015
- Launched SKYCellflu®, Korea’s first trivalent cell culture-based influenza vaccine
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
- 2013
- Received LEED GOLD certification for L HOUSE
- Established partnership with IVI (International Vaccine Institute) to collaborate on the development of a new typhoid conjugate vaccine
- 2012
- Established L HOUSE
2001 - 2009
Into the domestic healthcare market
- 2005
- Established vaccine R&D Center
- 2001
- Acquired Dongshin Pharm (vaccines, blood products)
