ENGLISH
|
JAPANESE
|
CONNECT WITH US:
Home
About
Contact
Log in
Home
Press release
Jul 13, 2022 15:30 JST
Source:
Novotech Health Holdings Pte Ltd
Novotech Client SK bioscience Achieves SKYCovione(TM) COVID-19 Vaccine Approval in Korea
SEOUL, S.KOREA, Jul 13, 2022 - (ACN Newswire) - Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, congratulates its client SK bioscience on the recent COVID-19 vaccine licence approval.
SK bioscience and GSK recently announced the successful authorization:
SK bioscience announced that 'SKYCovione(TM),' South Korea's first COVID-19 vaccine candidate adjuvanted with GSK's pandemic adjuvant has been authorized by the Korean Ministry of Food and Drug Safety (KMFDS). South Korea has become one of the few countries in the world to have both a domestically developed COVID-19 vaccine and a treatment.
SKYCovione(TM) is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK's pandemic adjuvant. The development of SKYCovione(TM) has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI).
The results of the Phase III clinical trial, collected in 4,037 adults over 18-year-old, showed that SKYCovione(TM) induced neutralizing antibody responses, against the SARS-CoV-2 parental strain. The neutralizing antibody titres increased about 33 times compared to before the injection and were 3 times that of AstraZeneca's Vaxzevria(TM), the control vaccine used in the study, 2 weeks after the second dose.
The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.
SK bioscience will apply for authorizations at other selected regulatory agencies for distribution of SKYCovione(TM), including through the COVAX Facility and for emergency use listing (EUL) to the World Health Organization (WHO).
SKYCovione(TM) is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, hepatitis B, and HPV. SKYCovione(TM) can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it is particularly suitable for use in low-income settings without the need for ultra-cold chain facilities.
The market expects that SKYCovione(TM) will accelerate securing of Korea's vaccine sovereignty and reducing dependence on vaccine imports.
Jaeyong Ahn, CEO of SK bioscience said, "The development of Korea's first COVID-19 vaccine was achieved based on the efforts of the government and members who have been working hard all day and night. We will continue to work with various global organizations based on our own research and manufacturing technologies to preemptively respond to new pandemics."
See full press release here
https://www.skbioscience.co.kr/en/news/news_01_01?mode=view&id=132&
Dr. John Moller, CEO Novotech said, "As the lead CRO managing the Phase lll study in six APAC countries, the entire team at Novotech congratulates SK bioscience for such an outstanding clinical success and subsequent licence approval. Licence approval is the ultimate goal in clinical research and drug development and we are honoured to be part of the process of bringing new life-saving therapies to market. We look forward to working with SK bioscience on further vaccine developments in the near future."
About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit
https://novotech-cro.com/contact
Media Contact
David James
E:
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427
Source: Novotech Health Holdings Pte Ltd
Sectors: BioTech, Healthcare & Pharm, Clinical Trials
Copyright ©2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
Latest Release
Eisai Satisfies All-Case Surveillance Requirement for Anticancer Agent Remitoro
May 16, 2025 17:21 JST
Premiere of New bZ Woodland BEV Focused on Driving Performance and Spaciousness in North America
May 16, 2025 16:35 JST
Mitsubishi Heavy Industries Activates New Driving Force for Data Center Business in the United States
May 16, 2025 15:43 JST
MHI Thermal Systems Receives JSRAE Technology Award
May 15, 2025 20:08 JST
Honda and Quemix Co-develop a New, World's First Quantum State Readout Technology
May 15, 2025 13:37 JST
Mitsubishi Electric Building Solutions Launches a New Projection-type Hall Lantern for Overseas Markets
May 15, 2025 11:00 JST
MHI Starts Operation of New CO2 Capture Pilot Plant at KEPCO's Himeji No.2 Power Station
May 14, 2025 16:50 JST
Making Anime More Interesting and Taking it into the Future, Launch of Three New Projects
May 14, 2025 11:00 JST
Adyen and JCB launch Card-on-File Tokenization to Enhance Payment Security
May 13, 2025 11:00 JST
TOYOTA GAZOO Racing fights back for double points finish
May 12, 2025 15:45 JST
JCB and Arab Bank launch JCB merchant acquiring operations across Jordan
May 12, 2025 11:00 JST
Mitsubishi Heavy Industries Achieves Highest-Ever Order Intake, Revenue, Net Income, and Free Cash Flow in FY2024, Increases Dividends, and Releases FY2025 Guidance
May 09, 2025 18:57 JST
Valuufy Selected by Global Tech Leader for Environmental Impact Assessment
May 09, 2025 18:00 JST
Mazda Adopts North American Charging Standard for BEVs launched in Japan
May 09, 2025 16:03 JST
Mitsubishi Motors to Launch an All-New BEV Based on Nissan's Next-Generation LEAF in North America in the Second Half of 2026
May 08, 2025 11:25 JST
Mitsubishi Motors and Foxtron Sign MOU for OEM Supply of EV
May 08, 2025 11:08 JST
Everest Medicines Announces NMPA Full Approval of NEFECON, Broadening Treatment Access for IgA Nephropathy Patients in China
May 07, 2025 19:06 JST
Anime Tokyo Station: Mobile Suit Gundam GQuuuuuuX -Beginning- Special Exhibition
May 03, 2025 03:00 JST
TOYOTA GAZOO Racing Set for Spa spectacle
May 02, 2025 19:29 JST
FWD Group reports exceptionally strong first quarter new business update
May 02, 2025 17:00 JST
More Latest Release >>
Related Release
The Evolving Global Landscape in Vaccine Development: Novotech and Endpoints News Webinar
February 15 2023 09:00 JST
Novotech Global Report: Robust Phase 1 Trial Growth Across Asia Pacific
February 10 2023 19:00 JST
Asia Pacific Cell & Gene Research Growing 50% Faster than ROW
February 03 2023 13:00 JST
Novotech Acquires US-based Drug Development Consulting Firm, CBR International
January 12 2023 15:00 JST
Novotech Acquires European CRO, Strengthens Global Operations
January 12 2023 15:00 JST
Novotech is Gold Sponsor at Biotech Showcase 2023
December 20 2022 11:00 JST
Data Shows 50% of New Trials Have Sites in Asia Pacific
December 15 2022 10:00 JST
Novotech Awarded the Asia Pacific CRO of the Year 2022 for Best Practices in Clinical Trials
December 06 2022 11:00 JST
Novotech Chairs BioCentury Summit Workshop on How to Build and Finance an East-West MRCT Strategy
November 11 2022 17:00 JST
Clinical Research Opportunities in China and the Path to USFDA Approval - Whitepaper
October 25 2022 18:00 JST
More Press release >>