SK Bioscience Vaccine Phase 1 Clinical Trial
Dongwha Pharm Therapeutic Phase 2 Clinical Trial
[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 23rd that it has approved the Phase 1 clinical trial plan for the novel coronavirus disease (COVID-19) vaccine 'NBP2001' developed by SK Bioscience and the Phase 2 clinical trial plan for the therapeutic agent 'DW2008S' by Dongwha Pharmaceutical.
The Phase 1 clinical trial of SK Bioscience's NBP2001 will evaluate safety and immunogenicity in healthy adults. This vaccine is a 'recombinant vaccine' manufactured using genetic recombination technology for the surface antigen protein of the COVID-19 virus.
The surface antigen protein of the vaccine stimulates immune cells to induce an immune response, and if the COVID-19 virus invades, antibodies eliminate the virus. Previously approved clinical trials involved two vaccines that were 'DNA vaccines,' which induce an immune response by injecting the gene of the surface antigen protein of the COVID-19 virus.
The Phase 2 clinical trial of Dongwha Pharmaceutical's 'DW2008S' will evaluate efficacy and safety in patients with moderate COVID-19. DW2008S is a natural product drug being developed as a new asthma treatment.
This clinical trial aims to confirm the potential of DW2008S as a COVID-19 treatment through exploration of new antiviral effects. This drug was evaluated for safety and tolerability in clinical trials involving healthy individuals during its development as an asthma treatment, and a Phase 2 clinical trial for asthma treatment is currently underway.
With today's approval, the total number of COVID-19 related clinical trial approvals in South Korea has increased to 30. Among these, 22 trials (19 therapeutics and 3 vaccines) are currently ongoing.
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