SK Bioscience said it has won the Ministry of Food and Drug Safety's approval to conduct phase 1 clinical trials of NBP2001, its Covid-19 vaccine candidate.

The company plans to carry out the phase 1 clinical trials of the candidate at Seoul National University Hospital and Seoul National University Bundang Hospital for healthy adults to evaluate the safety of the body and immunogenicity of the vaccine.

“We expect that NBP2001 will be able to secure high safety in that it is a stabilized synthetic antigen vaccine through protein culture and purification,” the company said. “SK Bioscience has developed cervical cancer vaccine candidates using the same synthetic antigen method, completed phase 2 clinical trials, and is about to enter global phase 3 clinical trials next year.”

Mass production is also possible as soon as development is completed at the company’s vaccine factory in Andong, North Gyeongsang Province, another factor that increases the chances of success of NBP2001, the company added.

The ministry’s approval comes after the company had secured more than expected results regarding the candidate’s safety and efficacy through a non-clinical trial.

During non-clinical trials, SK Biosciences induced a neutralizing antibody about 10 times higher than that of the serum of cured Covid-19 patients in the efficacy test of NBP2001 in primates.

Also, while the team confirmed 100 percent infection among primates that received placebo after direct administration of the Covid-19 virus to primates, the test group, in which neutralizing antibodies were induced through NBP2001, could block the proliferation of the virus in the respiratory tract such as airways and lungs.

“Our goal is to create a Covid-19 vaccine that has proven safety and effectiveness even if it is a little later than other vaccines that are currently getting ready for commercialization,” SK Bioscience CEO Ahn Jae-yong said. “The possibility of success is gradually increasing with active support from the government level.”