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The health Yuanlizhu vaccine V-01 attracts international attention; a clinical trial application for the COVID-19 vaccine has been submitted to Russia.
Published Time：
2021-07-14
According to a report by the Russian business newspaper Kommersant on July 13, Livzon Mabpharm Inc. (Zhuhai Livzon Mabpharm Biotechnology Co., Ltd.) recently submitted a registration application for its recombinant protein COVID-19 vaccine, V-01, to Russia.
Livzon Bio, a subsidiary of HealthGen, and Peng Hua's research team at the Institute of Biophysics, Chinese Academy of Sciences, have published the Phase II clinical trial results of the recombinant protein COVID-19 vaccine V-01, and published the Phase II clinical trial data in the Chinese Medical Journal. The results show that the recombinant protein COVID-19 vaccine V-01 has good safety and immunogenicity in the population that meets the Phase II clinical trial protocol. In addition, the elderly group showed more favorable safety compared to the young group.
According to relevant research reports, HealthGen Livzon's V-01 vaccine, as a potential best-in-class recombinant protein vaccine, has demonstrated superior safety, efficacy, durability, lower dosage, and easier scalability in its Phase I and II clinical trials.
In terms of safety, in the target dose of 10ug two-dose group, no grade 3 adverse events (such as fever or pain) attributable to vaccination were observed. In terms of antibody titer, among the reported COVID-19 vaccines, the ratio of V-01 to the neutralizing antibody titer in the serum of convalescents is in the international first echelon. Phase II clinical data show that V-01 showed outstanding performance in neutralizing antibody data compared with convalescents, and the neutralizing antibody titer in the adult group reached approximately 3 times that of convalescent serum neutralizing antibody titer.
What makes V-01 different from other COVID-19 vaccines?
First, recombinant protein vaccines themselves have three main advantages: First, they do not cultivate live viruses, eliminating concerns about virus leakage and reducing biosecurity requirements for production facilities; second, using genetic engineering technology to produce the RBD protein on the viral S protein enables high yield, high purity, and low cost; third, recombinant protein vaccines contain only the RBD protein, resulting in high purity and better safety.
Second, in terms of design, V-01 innovatively incorporates human-derived cytokines and other immunoactive components as biological adjuvants to comprehensively and durably activate the immune response against the COVID-19 virus.
According to the Phase II clinical trial data and results, the elderly group showed more favorable safety compared to the young adult group. The double-dose regimen not only showed good safety and tolerability, but also showed higher safety, especially for the elderly, while also achieving encouraging high-titer neutralizing antibodies.
As a leading pharmaceutical listed company in China, Livzon Group has industry-leading R&D capabilities, and is also strong in production capacity and channels. In order to meet the global demand for COVID-19 vaccines as soon as possible, Livzon Group is currently accelerating the construction and optimization of commercial production facilities for the vaccine, striving for the opportunity to obtain emergency use authorization. Considering the excellent performance of V-01 in Phase II clinical trials, the company said it is very much looking forward to outstanding performance in Phase III clinical trials, and is actively deploying Phase III clinical trials of V-01 in multiple countries.
Recombinant protein vaccines, as a new technological approach to developing COVID-19 vaccines, have attracted much attention from the industry and the market. The Phase I and II clinical results of HealthGen Livzon's recombinant COVID-19 vaccine V-01 have been positive, gradually increasing the international recognition of domestic brands. In the future, domestic vaccines will provide a "gold medal shield" for more and more people in epidemic prevention and control.
Source: Toutiao
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