SK bioscience : Material Business Matters Related to Investment Decisions (Application for change of domestic product license for Novavax Corona 19 vaccine (addition of indications for adolescents aged 12 to 17))

Material Business Matters Related to Investment Decisions

1. Title	Application for change of domestic product license for Novavax Corona 19 vaccine (addition of indications for adolescents aged 12 to 17)
2. Details	※ Other references useful for making invest decisions An application for product approval for a clinical trial drug does not guarantee the final approval decision of the drug regulatory body. In the screening process of product approval, results may not meet expectations, so there is a possibility that the company may change or abandon its commercialization plan. Investors are encouraged to invest carefully, taking into account the above and the investment risks disclosed in the business report. 1. Product name - NVX-CoV2373 (SARS-CoV-2 recombinant vaccine) 2. Target disease - Prevention of coronavirus infection-19 (COVID-19) caused by SARS-CoV-2 3. Date of application for product approval and approval agency - Application Date: April 7, 2022 - Clinical trial approval institution: Ministry of Food and Drug Safety (MFDS) 4. Clinical trial matters - Clinical trial registration number : NCT04611802 (Clinical trial progress is available on the US clinical registration site. (https://www.clinicaltrials.gov)) - Progress of clinical trial : A randomized, observer-blind, placebo-controlled Phase 3 clinical trial conducted in the United States with approximately 2,247 adolescents aged 12 to 17 years to evaluate the efficacy, immunogenicity, and safety of this vaccine against COVID-19. : The clinical trial started on June 5, 2021, and analysis was completed on October 1, 2021, based on the registration of the first patient, and an interim report including the results of the main endpoints was completed and submitted. - Results of clinical trials : As a result of the vaccine efficacy evaluation, it showed about 79.5% preventive effect compared to placebo, which is similar to the preventive effect of COVID-19 in adults. The trial was conducted at the time when the delta variant was dominant, and the preventive effect on the delta variant was about 82%. : In terms of safety, most of the adverse reactions that occurred after vaccination were mild or moderate. 5. Expected benefits - Recombinant SARS-CoV-2 antigen protein contained in this vaccine forms the antibodies against the SARS-CoV-2 virus inside the body, and exhibits an immune response when exposed to the SARS-CoV-2, enabling prevention against COVID-19. - After the addition of indications for adolescents, it is expected that the vaccination rate for adolescents, which is currently in the 60% range, will be increased and safety of all ages including adolescents will be maintained. 6. Future Plans - It is scheduled to start vaccination for adolescents after adding indications for adolescents.
3. Date of board resolution (decision date) or confirmation date	2022-04-07
- 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 clinical trial was conducted by Novavax, Inc., the original developer. - The above 3. The date of the resolution of the board of directors (the date of decision) or the date of fact confirmation is the date of submission of the product approval application.
※ Related disclosure	2022-01-14 Material Business Matters Related to Investment Decisions(Acquisition of Domestic Product License for Novavax COVID-19 Vaccine)