SK bioscience

2024
Received A Grade in MSCI ESG Rating 2023
Obtained WHO PQ for SKYTyphoid, Typhoid Conjugate Vaccine
Signed agreement with Sanofi on distribution of five major vaccines
Exported influenza vaccine, SKYCellflu®, to Thailand
Commenced expansion of L HOUSE
Signed a contract to distribute 5 major vaccines from Sanofi
Approval for the Phase 3 clinical trial plan (IND) of a 21-valent pneumococcal conjugate vaccine candidate, ‘GBP410’ (Sanofi)
Acquired Global Biotech IDT Biologika
Signed Power Purchase Agreement with SK E&S
Signed Simple Agreement for Future Equity(SAFE) with U.S Biotech Sunflower

2023
Received biologics license application approval of shingles vaccine in Malaysia
Received approval of world-first cell culture based quadrivalent influenza vaccine in Chile
Achieved ISO 27001 Certification
Signed CMO agreement with MSD for Next-Generation Zaire Ebola Vaccine Candidate
Achieved Marketing Auhorization from UK MHRA (SKYCovione™)
Granted Emergency Use Listing by the World Health Organization (SKYCovione™)
Signed a research collaboration agreement on influenza research with the Doherty Institute
Announced positive results from its Phase II clinical trials in infants of its 21-valent pneumococcal conjugate vaccine candidate, ‘GBP410’ (Sanofi)
Signed MOU with the Government Pharmaceutical Organization (GPO)
Published 2023 ESG Report
Donation to Local Community in Yecheon and Mungyeong,
Strategic Equity investment in Novavax
Collaboration agreement with Vaxxas to develop a second-generation typhoid conjugate vaccine
Signed MOU with Serbia to establish a strategic partnership in vaccine development and manufacturing.
Implements a Laboratory Information Management System(LIMS)
Development licensing agreement with Hilleman Laboratories for joint development of a second-generation Zaire Ebola virus vaccine.
Initiate Submission of Phase III Study Investigational New Drug Amendment to the U.S. FDA of 21-Valent Pneumococcal Conjugate Vaccine Candidate (Sanofi)

2022
Authorized ‘Nuvaxovid’ by KMFDS (Novavax, KMFDS)
Obtained additional EU-GMP Certification for COVID-19 Vaccine Facilities
Signed Advance Purchase Agreement of GBP510(KDCA)
Agreed SKY Varicella® distribution(PAHO)
Achieved Turkish GMP Certification (TITCK)
Achieved BLA of SKYTyphoid™ for export
Published first ESG report
Held SK bioscience Global Forum
Achieved BLA of SKYCovione™ (KMFDS)
Agreement to Manufacture COVID-19 Vaccine Containing Omicron Variant (Novavax)
Submitted CMA to the MHRA (SKYCovion™)
Submitted CMA to the EMA (SKYCovion™)
Achieved adolescent authorization of 'Nuvaxovid' by KMFDS (Novavax, KMFDS)
Signed agreement to develop mRNA Vaccines (CEPI)
Signed a MOU to co-develop new vaccine platforms (Hilleman Laboratories)
Donated to international Vaccine Institute to support global vaccine R&D
Received 'Grade A' rating on ESG Evaluation from the Korea Institute of Corporate Governance & Sustainability
Published first TCFD report

2021
Submitted application for export of typhoid vaccine (IVI, Bill & Melinda Gates Foundation)
Initiated clinical trials of 'GBP510'
Signed licensing & purchase agreement for Novavax’s COVID-19 vaccine candidate (Novavax, KDCA)
Funded to develop a vaccine candidate against COVID-19 (SARS-CoV-2) variants (CEPI)
New listed on KOSPI(Korea Composite Stock Price Index)
Obtained EU-GMP Certification for COVID-19 Vaccine Facilities
Secured funding for Phase III clinical trial of COVID-19 vaccine candidate 'GBP510' (CEPI)
MOU for expansion of factories and site (North Gyeongsang Province, Andong city)
Phase III trial for COVID-19 vaccine candidate 'GBP510'
Signed an agreement to extend capacity reservations for manufacturing COVID-19 vaccines (CEPI)
Submitted BLA submission for approval of the COVID-19 vaccine candidate, ‘NVX-CoV2373’ (Novavax, KMFDS)
Established ‘Park Mahnhoon Award’ (IVI)
Funded to develop a vaccine candidate against sarbecovirus (CEPI)
Earned the highest sales and operating profit

2020
Initiated Phase II clinical trial for the next-generation pneumococcal conjugate vaccine co-developed with Sanofi Pasteur
Began independent development of COVID-19 vaccine
Selected COVID-19 vaccine candidate for national project
Secured funding for development of COVID-19 from the Bill & Melinda Gates Foundation
Signed capacity reservation with CEPI for COVID-19 vaccine
Signed CMO agreement with AstraZeneca for the consigned production of COVID-19 vaccine
Signed CDMO agreement with Novavax for COVID-19 vaccine
Exported SKYVaricella® Inj. to Turkey
Announced as WAVE2 by CEPI with GBP510 (COVID-19 vaccine)
Initiated clinical trial for COVID-19 vaccine (GBP510, NBP2001)

2019
Intiated export influenza vaccine, SKYCellflu®, to Asian countries
Obtained WHO PQ for SKYVaricella® as world’s second
Gained WHO PQ for SKYCellflu® prefilled syringe/SKYCellflu®Quadrivalent prefilled syringe (world’s first for cell-cultured influenza vaccine)

2018
Launched SKY Varicella®
Signed agreement with Sanofi Pasteur to license out cell-culture technology for producing cell culture-based influenza vaccines
SK bioscience launched (Spun off from the vaccine business sector of SK chemical)
MOU with North Gyeonggi province and Andong city for expansion of L HOUSE (Vaccine Plant)

2017
Signed an agreement with international organization PATH to develop and produce pediatric enteritis vaccine for developing countries
Supply of SKYCellflu®Quadrivalent to Myanmar
Launched SKYZoster® Inj., world’s second shingles vaccine

2016
Obtained approval for SKYPneumo®, the first domestically produced PCV13 vaccine
Launched SKYCellflu® Quadrivalent, world’s first quadrivalent cell culture-based influenza vaccine
Selected health and safety management indicators (L House [Vaccine Plant]); received OHSAS18001, KOSHA18001 certification

2015
Launched SKYCellflu®, Korea’s first trivalent cell culture-based influenza vaccine

2014
Received KGMP certification for L HOUSE
Established strategic partnership with Sanofi Pasteur for co-development of next-generation pneumococcal conjugate vaccine

2013
Established partnership with IVI (International Vaccine Institute) to collaborate on the development of a new typhoid conjugate vaccine
Received LEED GOLD certification for L HOUSE

History