SK bioscience : Material Business Matters Related to Investment Decisions (Application for the domestic product licensing for COVID-19 vaccine GBP510)

Material Business Matters Related to Investment Decisions

1. Title	Application for the domestic product licensing for COVID-19 vaccine GBP510
2. Details	※ Cautions for investment The application for product licensing for the clinical trial drug does not guarantee the final licensing related decision of the drug regulatory agency. There may be results which do not meet expectations during the product licensing review process, and accordingly, there is always the possibility that our company may change or abandon our commercialization plan. Investors are kindly advised to invest carefully by comprehensively considering the investment risks disclosed via non-periodic disclosures and business reports, etc. 1. Product name - SKYCovione 2. Target disease(indications) - Prevention of COVID-19 infection caused by SARS-CoV-2 3. Date of application for product licensing and the relevant licensing agency - Date of application: April 29, 2022 - Product licensing agency: Ministry of Food and Drug Safety (MFDS) 4. Clinical trial related matters - Clinical trial registration number: NCT05007951 (Clinical trial progress is available on the US clinical registration site (https://www.clinicaltrials.gov)) - Progress of clinical trials: This phase 3 study aimed to assess the immunogenicity and safety of GBP510 25㎍ adjuvanted with AS03 in adults aged 18 years and older. The first subject was enrolled on 30th Aug 2021 and the enrollment of a total of 4,037 subjects was completed on 14th Jan 2022. As the primary endpoints, superiority and non-inferiority of immune responses in neutralizing antibodies were demonstrated after primary vaccination (2 doses at 4 weeks interval) compared to Vaxzevria which is a COVID-19 vaccine developed by AstraZeneca - Results of clinical trials: ① Immunogenicity Geometric mean titers (GMTs) after primary vaccination of GBP510 and Vaxzevria were 272.12 IU/mL and 92.75 IU/mL, and GBP510 showed a statistically significantly higher titer than Vaxzevria (P<0.0001). Seroconversion rates (≥4-fold increase of neutralizing antibodies from baseline) after primary vaccination of GBP510 and Vaxzevria were 98.06% and 87.30%, and GBP510 showed a statistically significantly higher seroconversion rate than Vaxzevria (P<0.0001). Cell-mediated immune responses were assessed by FluoroSpot 2 weeks after primary vaccination. Th-1 biased responses were observed in GBP510 group and similar or more CMI responses were observed in Th-1 cytokines (IFN-γ, IL-2, TNF-α) compared to Vaxzevria group. ② Safety Most solicited local and systemic reactions were mild and moderate in severity after each vaccination of GBP510, and recovered without any safety issues. No critical safety concerns were reported during the study period especially in terms of SAEs and AESIs Solicited local adverse event incidence rate: GBBP510 56.69%, Vaxzevria 49.20% (P<0.0001) Solicited systemic adverse event incidence rate: GBBP510 51.21%, Vaxzevria 53.51% (P=0.2058) Unsolicited adverse event incident rate: GBP510 13.34%, Vaxzevria 14.66% (p=0.2924) 5. Expected effect - SKYCovione, a SARS-CoV-2 recombinant protein nanoparticle vaccine is expected to emerge as a new alternative to immunization in the endemic era proving high safety and immunogenicity. - SKYCovione is also expected to serve as the one and only domestically developed vaccine against various variants after obtaining data of booster clinical trials and such. 6. Future Plans - Planned to be supplied domestically after the product licensing.
3. Date of board resolution (decision date) or confirmation date	2022-04-29
- 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
- "3. Date of board resolution (decision date) or the date of fact confirmation" is the date of submission of the product licensing application.
※ Related disclosure	2022-04-29 투자판단 관련 주요경영사항(COVID-19 백신 GBP510의 제3상 임상시험 결과 발표) 2021-08-10 투자판단 관련 주요경영사항 2021-06-28 투자판단 관련 주요경영사항