SK bioscience

Business Overview

SK bioscience has established a broad product portfolio and continues to invest in vaccine research,
which will be the driving force in the life science business in the future.
SK bioscience will develop premium vaccines based on superb technology and contribute promoting public health and contribute to the promotion of public health.

Speed of Execution with Quality

SKYVAX Program

SK bioscience's proprietary product supply to
developing countries including LMIC

Platform Technology

- Contractual development & manufacturing service
- Technology transfer to local manufacture including

Manufacturing Versatility

Out-licensing and co-development
for US and Europe market for next decade

Market Leading Sales
/ Marketing Infrastructure

Joint sales and consignment production
based on leading position
in domestic vaccine market

Share Innovation

Key milestones of SK bioscience

2009
- Out-licensed CSL’s NBP601 (hemophilia drug), Korea’s first bio-pharmaceutical drug
2013
- Established partnership with IVI (International Vaccine Institute)
  to collaborate on the development of a new typhoid conjugate vaccine
2014
- Established strategic partnership with Sanofi Pasteur for co-development of next-generation pneumococcal conjugate vaccine
2015
- Launched SKYCellflu, Korea’s first trivalent cell culture-derived influenza vaccine
2016
- Launched SKYCellflu Quadrivalent, world’s first quadrivalent cell culture-derived influenza vaccine
- Obtained approval for SKYPneumo, the first domestically produced PCV13 vaccine
2017
- Launched SKYZoster Inj.,
  world’s second shingles vaccine
- Signed agreement with international organization PATH to develop and produce pediatric enteritis vaccine
  for developing countries
2018
- SKYVaricella Inj. licensed to market, Korea’s second chickenpox vaccine
- Signed agreement with Sanofi Pasteur to license out cell-culture technology for producing cell culture-based influenza vaccines
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 Inj.
  as world’s second
2020
- Selected GBP510 as WAVE2 by CEPI with GBP510 (COVID-19 vaccine)
- Initiated clinical trial for in-house produced COVID-19 vaccine (GBP510, NBP2001)
- Started Phase II clinical trial for the next-generation pneumococcal conjugate vaccine co-developed with Sanofi Pasteur
- Signed CMO agreement with AstraZeneca for COVID-19 vaccine
- Signed CDMO agreement with Novavax for COVID-19 vaccine
2021
- Initiated Phase III trial for COVID-19 vaccine candidate 'GBP510'
- Received fund to develop a vaccine candidate against COVID-19 (SARS-CoV-2) variants (CEPI)
- Submitted application for export permit of typhoid vaccine co-developed with IVI
- Signed licensing & purchase agreement for Novavax’s COVID-19 vaccine candidate (Novavax, KDCA)
- Obtained EU-GMP Certification for COVID-19 Vaccine Facilities
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 Advance Purchase Agreement of GBP510(KDCA)
- Agreed SKYvaricella distribution(PAHO)
- Achieved Turkish GMP Certification (TITCK)
- Achieved BLA of SKYTyphoid for export
- Published first ESG report
- Achieved BLA of SKYCovione (KMFDS)
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 zoster vaccine in malaysia
- Initiate Submission of Phase III Study Investigational New Drug Amendment to the U.S. FDA of 21-Valent Pneumococcal Conjugate Vaccine Candidate (Sanofi)
2024
- Received A Grade in MSCI ESG Rating 2023

Business field

Process development

R&D center

Various platform technologies for diverse vaccine types

Process development team
Evaluation/analysis team
Bacterial vaccine team
Viral vaccine team
New project team

Development & commercial manufacturing

L HOUSE

Pioneer in successful adaptation of ‘single-use system’ for vaccines on commercial scale
‘Multi-modular system’ for diverse vaccine types

Flexibility using single-use System
Diverse platforms
Future expansion

Professional sales/marketing

Professional

Specialized sales/marketing infrastructure make the company as a leader in the domestic vaccine market
Various consignment production systems improve the convenience of vaccination

Unified system from licensing to selling
Specialized strategies for public/private market
Portfolio for all ages,
from infants to elderly