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Biotech & Drug DiscoveryKOSPI 30244018 approvals8 trials

SK Bioscience Co.,Ltd

Official website

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

As of 2026-10-10, SK Bioscience Co.,Ltd has 18 Korean MFDS drug approvals, 55 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

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
Show 6 more
  • 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

Global clinical trials

ClinicalTrials.gov · sponsor-matched
Show 2 more trials

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

Key disclosures

KRX KIND via OpenDART
Show 9 more events

Publications

PubMed · affiliation-matched
Show 45 more publications

Patents

KIPRIS · applicant-matched
Show 183 more patents

AI reads

MAA server logs · IP-verified
262
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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

A diversified SK group company operating eco-friendly chemical materials alongside pharmaceutical products like Joins and vaccines through subsidiary SK Bioscience.

AHNLAB,INC.100

KOSDAQ-listed integrated security company behind the V3 antivirus and AhnLab TrusGuard and XDR solutions.

Inventage Lab Inc.100

Drug delivery system company behind the long-acting injectable platform IVL-DrugFluidic and the LNP delivery platform IVL-GeneFluidic.

ORGANOIDSCIENCES LTD.100

Organoid-based biotech founded 2018, KOSDAQ-listed 2025, developing the ATORM-C regenerative therapeutic and ODISEI evaluation solution.

Eone Diagnomics Genome Center Co., Ltd.85

EDGC, a Korea-US joint venture of Eone Medical Foundation and Diagnomics, offers the NIPT service NICE and liquid biopsy OncoCatch.

CG Invites Co., Ltd.85

Genomics and drug developer behind the osteoarthritis drug Acelex and the AI-driven healthcare platform Invites Loop.

Y-Biologics, Inc85

KOSDAQ-listed antibody biotech developing the next-generation immuno-oncology candidate Multi-AbKine on its fully human antibody library Ymax®-ABL.

GC Corp.85

A holding company overseeing 54 affiliates including its main biopharmaceutical subsidiary GC, with no direct product manufacturing of its own.

Prestige BioPharma Limited85

Founded in 2015 and listed on KOSPI in 2021, Prestige BioPharma develops antibody biosimilars and novel antibody drugs including Tuznue.

GENEMATRIX INC.85

KOSDAQ-listed biotech company developing molecular diagnostics with proprietary C-Tag technology and the NeoPlex product line.

SillaJen, Inc.85

SillaJen, Inc., founded in 2006 and listed on KOSDAQ in 2016, develops the oncolytic virus immunotherapy Pexa-Vec.

MEDIPOSTCO.,LTD.83

Medipost, founded in 2000 and KOSDAQ-listed in 2005, specializes in cord blood banking and stem cell therapeutics.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

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