SK Bioscience Receives Approval for Recombinant Corona Vaccine Phase 1 Clinical Trial … Dong Wha Pharm is a Phase 2 Clinical Trial



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FDA approval … Cumulatively increased to 19 treatments and 3 vaccines
SK Biosciences is surprised by the announcement of the immunological effect of AstraZeneca, which has signed a letter of intent for cooperation for the national and global supply of vaccines.

President Moon Jae-in visited SK Bioscience in Seongnam City, Gyeonggi-do on the 15th to check the development of a new vaccine against coronavirus infection (Corona 19), and is looking at a microscope in a cell culture room . Seongnam = Yonhap News

The new coronavirus infectious disease (Corona 19) vaccine being developed by SK Bioscience and the Corona 19 treatment agent developed by Dong Wha Pharm have been approved by the Ministry of Food and Drug Safety. Accordingly, SK Bioscience plans to conduct phase 1 clinical trials and Donghwa Pharm will conduct phase 2 clinical trials.

The Ministry of Food and Pharmaceutical Safety announced on the 23rd that it approved the clinical plan for SK Bioscience’s COVID-19 candidate vaccine ‘NBP2001’ and Donghwa Pharm’s COVID-19 treatment candidate ‘DW2008S’.

Consequently, SK Bioscience plans to evaluate the safety and immunogenicity of NBP2001 in healthy adults in the future. The plan is to observe how many neutralizing antibodies to eliminate or reduce viral infectivity increase. NBP2001 is a candidate material for a recombinant vaccine using the surface antigen protein of Corona virus 19. It was manufactured using genetic recombination technology and the prevention principle is that the surface antigen protein of the vaccine stimulates immune cells to induce an immune response. The antibody thus formed kills corona virus 19 when it invades.

Dong Wha Pharm also plans to evaluate the effectiveness and safety of DW2008S in patients with moderate corona19. DW2008S is a natural medicine that is being developed as a new medicine to treat asthma.

As a result, there are currently 30 corona19-related clinical trials approved in Korea, of which 22 (19 treatments and 3 vaccines) are ongoing.

Both cases that were approved for clinical trials prior to SK Bioscience were DNA vaccines, with the principle of inducing an immune response by injecting the Corona 19 surface antigen protein gene.

Meanwhile, SK Bioscience and the Ministry of Health and Welfare previously signed a letter of intent for three-way cooperation with a multinational pharmaceutical company AstraZeneca in July for the domestic and global supply of the Corona 19 vaccine. According to foreign media of the day, the average immunological effect of the vaccine that AstraZeneca is developing in partnership with the University of Oxford in the UK was 70%.

The letter of intent for the cooperation contained a three-way cooperation, including the rapid and stable production and global supply of the vaccine candidate ‘AZD1222’, the expansion of production capacity to respond to the increasing demand and the improvement of the health through internal supply efforts. Additionally, SK Bioscience plans to engage in manufacturing by signing a production on consignment (CMO) contract with AstraZeneca for AZD1222. Accordingly, the AstraZeneca vaccine is expected to be supplied to Korea.

Reporter Kim Dong-hwan [email protected]

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