Caijing.com’s announcement shows that the Phase II sequential intensified clinical trial of its new adjuvant recombinant protein new crown vaccine ReCOV in the Philippines has achieved positive results. The results of the study showed that the levels of true virus neutralizing antibodies against Omicron mutant strains BA.5 and BA.2 and prototype strains induced by ReCOV sequential boosting were significantly better than those in the mRNA vaccine group (the difference was statistically significant). At present, Ruike Bio has submitted a rolling application for product listing to the Chinese regulatory authorities.
The information shows that since then, a total of 600 subjects have been enrolled in the clinical study, and all subjects have completed two doses of inactivated vaccine basic immunization. According to random grouping, ReCOV vaccine or control vaccine Pfizer mRNA vaccine (COMIRNATY®) were used sequentially. Booster vaccinations to compare the immunogenicity and safety of ReCOV versus mRNA vaccine booster immunizations.
According to Ruike Biotech, “To carry out head-to-head immunogenicity comparisons, especially for neutralizing antibodies, the indicators that can be detected include prototype strains and various variant strains available at this stage, in terms of antibody strength and width. This is the current international mainstream method for comparing new crown vaccine products.”
It is reported that ReCOV vaccine is a next-generation recombinant protein vaccine developed by Ruike Biotechnology using new adjuvants, protein engineering platforms and other technology platforms. It uses optimized antigens (belonging to NTD-RBD-foldon trimers), which are highly expressed by CHO cells and can form Highly similar structure to native spike protein.
It is worth noting that the ReCOV vaccine is equipped with the oil-in-water BFA03 adjuvant independently developed by Ruike. Ruike Bio is one of the few companies in the world capable of developing new adjuvant systems. In the past, most domestic vaccine companies could only obtain adjuvants by cooperating with GSK and other companies, which was controlled by others to some extent. Ruike Biotech previously stated that BFA03 is a new type of adjuvant against GSK’s adjuvant AS03.
It is reported that an adjuvant is a substance used in combination with an antigen, which can enhance the body’s immune response to the antigen or change the type of immune response. The selection of effective adjuvants is crucial to improve the protective efficacy of vaccines. An ideal adjuvant can be perfectly combined with an antigen to synergistically stimulate an immune response with optimal strength, breadth and type, and improve the protective efficacy of the vaccine.
Hua Securities pointed out in the research report that ReCOV’s leading neutralizing antibody titer is largely due to its self-developed new oil-in-water adjuvant BFA03. It is this adjuvant that enables ReCOV to have a good broad cross-neutralization protection against mainstream mutant strains including Omicorn and others.
In addition, Ruike Biotech also mentioned the role of the adjuvant BFA03 in terms of safety. Biologically pointed out.
In addition to effectiveness and safety, another indicator for assessing vaccines—accessibility, Ruike Bio said, “From the perspective of accessibility, the main focus is on the scalability of the process and the autonomy of the supply chain. new and storage transport conditions.”
It is understood that Ruike Bio has already deployed production capacity in advance. The construction of ReCOV’s GMP standard production base was completed in November 2021 and a production license was obtained; in April 2022, the production base obtained a declaration of conformity issued by the EU quality authorized person (QP). The total construction area of the base is about 17,000 square meters, which may support an annual production capacity of 300 million doses of ReCOV.
According to Ruike Biotech, the production capacity is designed to be more than 200 million doses. “According to the general product launch rules, it usually takes 3-6 months to reach full production, and Ruike Bio will try to shorten the ramp-up time of production capacity.”
【Author: Duan Jingyuan】 (Editor: Duan Jingyuan)
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