For the candidate substance 'GBP510' announced by the government as a domestic vaccine, the Gates Foundation paid for it, and SK Bioscience designed the 'Self Assembly Nanoparticle' of the Institute for Protein Design (IPD), Washington University, USA. In addition to the technology, it seems that it is not 'domestic' as the pandemic immune adjuvant technology of GSK (GlaxoSmithKline), a multinational pharmaceutical company, is applied.
Regarding the 'receptor binding protein' (RBD) of 'GBP510', a COVID-19 vaccine candidate, which the Ministry of Food and Drug Safety approved for phase 3 clinical trial on the 10th, SK Bioscience said, "Our genetic recombination technology and IPD's 'self-binding nanoparticle' design technology It has been confirmed that RBD nanoparticles, which are stably structured, induce a very high level of neutralizing antibody and block virus proliferation. We will proceed with the Phase 3 clinical trial of GBP510 by combining GSK's pandemic immune enhancer technology designed to increase the
In particular, regarding GSK's pandemic immune enhancer technology, he said, "It induces a clear and sustained immune response by broadly stimulating the spike protein antigen." Regarding the Phase 3 clinical trial, "The International Vaccine Research Institute (IVI) has “Performed phase 3 clinical trial”, SK’s role was limited to some domestic clinical trials.
Regarding the development cost, “The GBP510 cost was paid a total of $213.7 million by the Gates Foundation and CEPII (Coalition for Epidemic Preparedness Innovation), an international private organization from the beginning, of which about $173 million was R&D including phase 3 clinical trial” SK Bioscience’s role is to reveal “Phase 3 clinical trials and licensing, development of commercial processes with an annual production scale of hundreds of millions of doses, introduction of related raw materials, and plans to invest additional research and R&D expenses compared to mutants” Participation is key.
Prior to the announcement of the 'domestic vaccine', the government had an obligation for 'rapid results' in domestic clinical trials by signing the 'Multinational Phase 3 Joint Analysis Agreement' between SK Bioscience IVI (International Vaccine Research Institute), the National Institute of Health, Korea Centers for Disease Control and Prevention. It seems difficult to publish single results before clinical results.
SK Bio, which has become a technology leader, is a 'joint vaccine engineer' with its existing 'genetic recombination' technology and its stock soared as the government's 'domestic vaccine No. 1'.
GBP510 candidate material is prepared to obtain WHO's PQ (Pre-qualification) certification for multi-country phase 3 clinical trials in Europe and Southeast Asia according to International Vaccine Research Institute IVI, the global leader in phase 3 clinical trials, and to obtain emergency use licenses in each country All procedures apply.
Minister of Food and Drug Safety Kim Gang-lip said on the same day, “It is correct to approve the phase 3 clinical trial only after completing the phase 2 clinical trial. However, since the safety and effectiveness were sufficiently recognized from the phase 1 results, it was decided at an expert review meeting that the phase 3 clinical trial would be possible even with the phase 1 results.”
President Moon Jae-in said on the same day, “I hope that the first domestically produced vaccine can be commercialized. The government will provide all-round support so that domestic clinical trials can be carried out quickly and sufficiently,” he said at the Blue House meeting the day before (9th), “In order not to be swayed by foreign companies, accelerate the development of domestic vaccines and concentrate national capabilities on vigorously promoting the global hub strategy. I will,” he said.
SK Bio excluded the delta mutation clinical trial, which has already become the dominant species in Korea, and explained the reason that "a mutant strain vaccine does not take long if a prototype vaccine is made."