EuBiologics files for phase 3 study of homegrown COVID-19 vaccine

EuBiologics has asked for the Ministry of Food and Drug Safety’s approval on its plan to conduct a phase 3 clinical trial of its self-developed COVID-19 vaccine candidate, becoming the second South Korean company to reach that stage in the race to develop homegrown vaccines.

According to the company’s regulatory filing on Wednesday, the clinical study of its vaccine candidate EuCorVac-19 will involve 4,000 participants. The safety and efficacy of the vaccine will be evaluated through comparison with the AstraZeneca vaccine, the company added.

EuCorVac-19 is a recombinant protein vaccine made with genetic recombination technology. The surface antigen of the vaccine stimulates the immune cell to produce neutralizing antibodies to fight COVID-19.

If approved, EuBiologics will become the second local company after SK Bioscience to commence a phase 3 clinical trial of a homegrown COVID-19 vaccine.

The company plans to seek regulatory approvals for phase 3 clinical trials in foreign countries as well.

In June, EuBiologics completed its phase 1 clinical study and started a phase 2 clinical trial for the vaccine candidate. The company said it has now finished administrating the drug candidate to 230 healthy adults.

The release of the phase 2 study results is slated for November.

Meanwhile, EuBiologics is adding a 1,000-liter culture line in the company’s second plant in Chuncheon, Gangwon Province. After the expansion, the company expects to have an annual manufacturing capacity of around 100 million to 200 million doses of EuCorVac-19.

By Shim Woo-hyun (ws@heraldcorp.com)