If approved, SK bioscience will accelerate to apply for emergency use listing (EUL) to the World Health Organization (WHO)

SK bioscience, a global innovative vaccine and biotech company dedicated to promoting human health from prevention to cure across the globe, announced that the company applied for a Conditional Marketing Authorization (CMA) of the joint-developed COVID-19 vaccine, ‘SKYCovion™’ to the UK Medicines and Healthcare Products Regulatory Authority (MHRA).

SKYCovion™ has been submitted to an application for rolling review by the MHRA since March. SK bioscience additionally applied the recently secured Phase III clinical data of SKYCovion™ for a formal conditional approval.

Following UK submission, SK bioscience also plans to quickly apply for conditional approval to the European Medicines Agency (EMA), Emergency Use Listing (EUL) to the World Health Organization (WHO). If the EUL is obtained, SKYCovion™ will be made available to the COVAX Facility for procurement and equitable allocation worldwide, if required.

Jaeyong Ahn, CEO of SK bioscience said, “With this submission, we have taken a further step to make available a jointly developed Korean COVID-19 vaccine with high immunogenicity and safety around the world. Starting with the UK application, we hope to introduce Korea´s technology to the global vaccine market and achieve our global health aspirations.”

SKYCovion™ is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant. The development of SKYCovion™ has been supported by funding from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union’s Horizon 2020 Programme.

The results of the Phase III clinical trial,collected in 4,037 adults over 18-year-old, showed that SKYCovion™ induced neutralizing antibody responses, against the SARS-CoV-2 parental strain. The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.

SKYCovion™ also showed cross-neutralizing activity against Omicron variant BA.1 when administered as a booster. The results of the Phase I/II clinical trial, conducted with 81 healthy adults who received a booster dose of SKYCovion™ 7 months after the second dose of SKYCovion™, showed that the neutralizing antibody titres against the Omicron variant BA.1 were 25 times the titers observed two weeks after two primary doses.

SK bioscience is currently conducting heterologous and homologous booster clinical trials of SKYCovion™. Further, SK bioscience plans to conduct a research study to assess the preventive effect of SKYCovion™ against subvariants of Omicron by utilizing the SKYCovion™’s platform.

Separately, SK bioscience initiated the development of a universal vaccine candidate effective for the entire Sarbecovirus group to establish a broader protection system against COVID-19 variants and SARS in the future.