Material Business Matters Related to Investment Decisions
1. Title Approval of the domestic product licensing for COVID-19 vaccine SKYCovione(GBP510)
2. Details 1) Product name
- SKYCovione(GBP510)

2) Target disease (indications)
- Prevention of COVID-19 infection caused by SARS-CoV-2

3) Date of application for product approval, Date of approval and approval agency
- Date of application: 2022-04-29
- Date of approval: 2022-06-29
- Product licensing agency: Ministry of Food and Drug Safety (MFDS)

4) Expected effect:
-SKYCovione is a recombinant protein nanoparticle vaccine containing the receptor binding domain of SARS-CoV-2 Spike (S) protein from the parental D614G strain and an adjuvant system (AS03).
- Strong neutralizing antibodies that may contribute to the prevention of COVID-19 were induced by primary vaccination of SKYCovione. In terms of safety, overall, SKYCovione showed a clinically acceptable safety profile.
- SKYCovione is a thermostable refrigerated vaccine which could be an interesting feature in various countries.
- In addition, booster dose neutralizing antibody response is currently being evaluated in clinical trials.

5) Future plan:
- Domestic and foreign supply with global license application planned
3. Date of board resolution (decision date) or confirmation date 2022-06-29
- Attendance of outside directors Present(No.) -
Absent(No.) -
- Attendance of auditors (members of Audit Committee who are not outside directors) -
4. Other matters to be factored into investment decisions
- The above '3. Date of board resolution (decision date) or confirmation date' is the date of the approval.
※ Related disclosure2022-05-02 Material Business Matters Related to Investment Decisions(Application for the domestic product licensing for COVID-19 vaccine GBP510)
2022-05-02 Material Business Matters Related to Investment Decisions(Announcement of the key results of Phase III clinical of COVID-19 vaccine GBP510)

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SK Bioscience Co. Ltd. published this content on 29 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 June 2022 06:06:06 UTC.