Europe and WHO also promote use of permission SK Bioscience is preparing to advance into overseas markets for a domestic COVID-19 vaccine that is currently being developed in-house.
SK Vasa announced on the 16th that it had submitted a sequential review document to the UK pharmaceutical regulatory authority for the expedited approval of GBP510, a COVID-19 vaccine candidate.
SK BASA aims to go through the sequential screening stage with the goal of obtaining conditional approval in the UK and to proceed to the final evaluation as quickly as possible. MHRAs sequential review is a system for accelerating the evaluation of promising vaccines and therapeutics, and it is a method of promptly reviewing efficacy, safety, and quality data before applying for final approval.
The sequential review documents submitted by SK Vasa are quality data, non-clinical toxicity, efficacy tests, and phase 1/2 clinical data.
SK BASA plans to submit the GBP510 sequential review documents to the EMA in the first half of this year along with the UK MHRA. It also plans to obtain emergency use permits from the World Health Organization and emergency use permits by foreign countries. Based on this, it plans to advance into the global market and lead the successful globalization of domestic vaccines.
GBP510 is currently undergoing phase 3 clinical trials to verify safety and effectiveness at home and abroad, and has recently started to expand the scope of inoculation through additional clinical trials. Simultaneously with the commercialization of GBP510, it plans to expand the scope of use to booster shots and children and adolescents. Experts are paying attention to the fact that GBP510 is a synthetic antigen method that has been used for a long time in existing vaccines such as influenza, hepatitis B and cervical cancer vaccines and has proven safety and effectiveness.
It can create a differentiated market only for synthetic antigen vaccines, such as inducing inoculation of people who are reluctant to the previously developed COVID-19 vaccine, and it can be refrigerated at 2 to 8 degrees Celsius and stored for a long time, not only in Korea but also around the world, including underdeveloped countries. It is expected to contribute to encouraging vaccination.
Ahn Jae-yong, president of SK Bioscience, said, “As we enter the endemic era, the need for periodic vaccination and development of new vaccines against mutated viruses is constantly being raised.” We will lead the domestic and foreign vaccine industry by expanding R&D into various fields based on a platform that can overcome them.”
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