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Biotech & Drug DiscoveryKOSPI 30244018 approvals8 trials

SK Bioscience Co.,Ltd

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A vaccine specialist developing in-house products such as SKYCellflu and SKYZoster while also serving as CDMO for AstraZeneca and Novavax.

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Business overview

Source: DART corporate disclosure

Established in 2018 through a spin-off of SK Chemicals' vaccine division and listed on KOSPI in 2021, SK Bioscience is a vaccine-focused company. It has developed in-house vaccines including the cell-culture flu vaccines SKYCellflu and SKYCellflu4, the shingles vaccine SKYZoster, the varicella vaccine SKYVaricella, the typhoid conjugate vaccine SKYTyphoid, and the COVID-19 vaccine SKYCovione, while also serving as CDMO for AstraZeneca's Vaxzevria and Novavax's Nuvaxovid. Under a 2014 co-development agreement with Sanofi worth US$45.0M plus EUR350M, it is running a global Phase 3 trial of a 21-valent pneumococcal vaccine in about 9,000 children and adolescents, and has a US$140.0M agreement with CEPI covering the mRNA-based Japanese encephalitis vaccine GBP560.

Products & technology

  • SKYCellfluCell-culture trivalent influenza vaccine
  • SKYCellflu4Cell-culture quadrivalent influenza vaccine
  • SKYZosterShingles vaccine
  • SKYVaricellaVaricella vaccine
  • SKYTyphoidTyphoid conjugate vaccine
  • SKYCovioneCOVID-19 vaccine (GBP510)

Regulatory approvals

data.go.kr

18 Korean MFDS drug approvals · 1998–2022

  • MFDS drugSkyCovione Multi Injection2022-06-29
    Drug · Prescription · Approval202202677
  • MFDS drugSKYTyphoid multi inj. (Thyphoid purified Vi Polysaccharide Conjugated to Diphtheria toxoid vaccine)2022-05-12
    Drug · Prescription · Approval202201983
  • MFDS drugNUVAXOVID Pre-filled syringe (SARS-CoV-2 Spike Protein Vaccine(Recombinant))2022-01-12
    Drug · Prescription · Approval202200228
  • MFDS drugSKYPneumo Prefilled syringe (Pneumococcal Polysaccharide Conjugated to Diphtheria CRM 197)2021-06-04
    Drug · Prescription · Approval202104391
  • MFDS drugSKYPneumo Prefilled syringe (for export)Revoked2020-05-14
    Drug · Prescription · Approval202003491
  • MFDS drugSKYCellflu Prefilled Syringe (for export)2020-01-10
    Drug · Prescription · Approval202000160
  • MFDS drugSKYCellflu Quadrivalent Prefilled Syringe (0.5mL) (for export)2020-01-09
    Drug · Prescription · Approval202000155
  • MFDS drugSKYCellflu Quadrivalent Multi inj. (surface antigen, inactivated, prepared in cell culture) (for export)2019-02-22
    Drug · Prescription · Approval201901145
  • MFDS drugSKYCellflu Quadrivalent inj. (surface antigen, inactivated, prepared in cell culture) (for export)2019-02-18
    Drug · Prescription · Approval201900985
  • MFDS drugSKYVaricella Inj. (Varicella Virus Vaccine (live) [Oka/SK])2018-06-04
    Drug · Prescription · Approval201802323
  • MFDS drugSKYZoster Vaccine Inj. (Zoster Virus Vaccine (live) [Oka/SK])2017-09-29
    Drug · Prescription · Approval201707343
  • MFDS drugSKYCellflu®Multi inj. (Trivalent Influenza Vaccine) (for export)2017-09-06
    Drug · Prescription · Approval201706967
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  • MFDS drugSKYCellflu®inj. (Trivalent Influenza Vaccine) (for export)2017-03-27
    Drug · Prescription · Approval201701434
  • MFDS drugSKYCellflu Quadrivalent Prefilled Syringe (Surface Antigen, Inactivated, prepared in cell culture)2015-12-24
    Drug · Prescription · Approval201508425
  • MFDS drugSKYCellflu Prefilled Syringe (Surface Antigen, Inactivated, prepared in cell culture)2014-12-26
    Drug · Prescription · Approval201406070
  • MFDS drugHepamun Prefilled Syringe (Hepatitis B Vaccine(rDNA))2012-04-24
    Drug · Prescription · Approval201203144
  • MFDS drugSK Td Vaccine Inj. (Pre-filled Syringe) (Adsorbed Diphtheria-Tetanus combined Toxoid for adult)Revoked2005-02-28
    Drug · Prescription · Approval200501774
  • MFDS drugHepamune Inj. (Hepatitis B Vaccine, recombinant)Revoked1998-11-10
    Drug · Prescription · Approval199801806

Clinical trials

data.go.kr

8 MFDS clinical trial authorisations · 2016–2025 (Phase 3 4 · Phase 1 2 · Phase 1/2 2)

  • Phase 3스카이바리셀라주(NBP608)2025-12-16

    10 trial sites

  • Phase 1NBP18012025-04-14

    1 trial site

  • Phase 3GBP5102021-08-10

    19 trial sites

  • Phase 1/2GBP5102021-01-26

    15 trial sites

  • Phase 1/2GBP5102020-12-31

    15 trial sites

  • Phase 1NBP20012020-11-23

    3 trial sites

  • Phase 3SK-NBP607QIV세포배양인플루엔자백신주-4가2018-08-31

    12 trial sites

  • Phase 3SK-NBP607QIV세포배양인플루엔자백신주-4가2016-10-06

    12 trial sites

R&D and key agreements

Source: DART corporate disclosure

21가 폐렴구균백신(GBP410) · 폐렴구균 감염증 · 글로벌 임상 3상 · Co-developed with Sanofi since 2014; Phase 3 in ~9,000 children/adolescents from Dec 2024

차세대 폐렴구균백신(NextGen) · 폐렴구균 감염증 · 기초연구/비임상 · Expanded co-development deal with Sanofi (2024)

일본뇌염 mRNA백신(GBP560) · 일본뇌염 · 글로벌 임상 1/2상(2025~) · Co-developed with CEPI since 2022

라싸열 mRNA백신(GBP570) · 라싸열 · 기초연구 · Co-developed with CEPI

범용 사베코바이러스백신(GBP511) · 사베코바이러스 감염증 · 임상 1/2상 IND 승인 · CEPI agreement, Dec 2021, US$65.1M

Nasal Spray 백신 · 임상시료 생산완료/안정성시험 진행중 · IAVI agreement, Nov 2021, US$4M

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Companies approved for the same productsBiotech & Drug Discovery

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

SK Chemicals Co., Ltd.1 shared

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Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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