SK Bioscience said it submitted a rolling review document for the rapid approval of the GBP510, its Covid-19 vaccine candidate, to U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA).
The company aims to go through the sequential screening stage and proceed to the final evaluation as quickly as possible with the goal of achieving conditional marketing authorization (CMA) from the MHRA.
MHRA's rolling review is a system for accelerating the evaluation of promising vaccines and therapeutics. It promptly reviews a treatment or vaccine's efficacy, safety, and quality data sequentially before the company applies for final approval.
SK Bioscience has submitted its quality data, non-clinical toxicity, efficacy tests, and phase 1/2 clinical data to the U.K. health agency to initiate the rolling review. It will submit its ongoing phase 3 clinical trial data as soon as it analyzes the data.
SK Bioscience also plans to submit the GBP510 sequential review documents to the EMA in the first half of this year. It plans to acquire WHO's emergency use listings and emergency use approvals from other foreign countries.
Based on the approvals from various countries worldwide, the company aims to advance into the global market and lead the successful globalization of Korean-made vaccines.
"As we enter the endemic era, the need for periodic vaccination and development of new vaccines against mutated viruses is constantly being raised," SK Bioscience CEO Ahn Jae-yong said. "Based on a platform that can overcome the current and future pandemics, we will expand R&D into various fields to lead the vaccine industry."
SK Bioscience developed GBP510 with the University of Washington's Institute for Protein Design and used GSK's adjuvants in the clinical trials.
GBP510 is undergoing a global phase 3 clinical trial to verify safety and effectiveness. SK Bioscience has recently started expanding the scope of vaccination through additional clinical trials.
The company aims to expand the scope of the vaccine to include booster shots and children and adolescents simultaneously with its efforts to commercialize GBP510.
SK Bioscience has also started research to confirm the preventive effect of GBP510 on Covid-19 variants, such as Omicron. It builds a platform to respond to the next pandemic using GBP510 development technology.
The company recently confirmed that the booster shot showed a preventive effect on Omicron virus from participants in the GBP510 phase 1 and 2 clinical trials and is conducting a comprehensive study.
SK Bioscience is also looking into developing a vaccine targeting the sarbecovirus, which includes Covid-19 and SARS (Severe Acute Respiratory Syndrome) viruses and related variants.