SK bioscience : Material Business Matters Related to Investment Decisions (Application for EMA conditional marketing authorization (CMA) for COVID-19 vaccine, SKYCovion(GBP510))

Material Business Matters Related to Investment Decisions

1. Title	Application for EMA conditional marketing authorization (CMA) for COVID-19 vaccine, SKYCovion(GBP510)
2. Details	※ Other references useful for making invest decisions 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 - SKYCovion (GBP510) 2. Target disease(indications) - Active immunization for the prevention of COVID-19 in individuals ≥ 18 years of age 3. Date of application for product licensing and the relevant licensing agency - Date of application: July 30, 2022 - Product licensing agency: EMA(European Medicines Agency) 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: Excellent immune response was demonstrated, satisfying all primary endpoints with neutralizing antibody geometric mean titer (GMT) ratio against comparator(Vaxzevria) of 2.93 (95% CI: 2.63 - 3.27) and seroconversion rate of 98% (difference with the control was 10.8%, 95% CI: 7.68 - 14.32). Most solicited local and systemic reactions were mild and moderate in severity after each vaccination of GBP510, and recovered without any specific issues. No critical safety concerns were reported especially in terms of serious adverse event and adverse events of special interest. 5. Expected effect - Strong neutralizing antibodies that may contribute to the prevention of COVID-19 were induced by primary vaccination of SKYCovion. In terms of safety, overall, SKYCovion showed a clinically acceptable safety profile. - SKYCovion is a thermostable refrigerated vaccine which could be an interesting feature in various countries. - Approval of stringent agency, EMA, is expected to accelerate expansion of regulatory approvals world-wide. 6. Future plan - Planning to supply EU area and expand the market world-wide, upon receipt of EMA approval.
3. Date of board resolution (decision date) or confirmation date	2022-07-30
- 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	2022-05-02 Material Business Matters Related to Investment Decisions(Announcement of the key results of Phase III clinical of COVID-19 vaccine GBP510)