SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate.
The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant.
SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.
In the study, the vaccine candidate performed better in terms of neutralizing antibody levels than AstraZeneca’s Vaxzevria COVID-19 vaccine. SKYCovione also had a good safety profile in the study. In particular, it generated neutralizing antibody titers almost three times more than the control vaccine two weeks after administering the second dose.
“At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 global health crisis, SK Bioscience has reached the final stage of developing Korea’s first COVID-19 vaccine for the benefit of Korea and the world,” said Jae-Yong Ahn, CEO of SK bioscience, in a news release.
Seongnam-si, Korea-based SK Bioscience has an advanced agreement with the Korean government to sell 10 million vaccine doses following regulatory authorization.
The company is also petitioning the WHO for an emergency use listing of the vaccine.
SK Bioscience continues to test the vaccine as a homologous and heterologous booster.
Filed Under: clinical trials, Drug Discovery, Infectious Disease