New adjuvant new crown pneumonia epidemic Miao ReCOV updated a number of overseas clinical research progress

Rico Biotech (02179.
HK) is pleased to announce that ReCOV, a recombinant two-component novel coronavirus vaccine, has recently obtained positive data
from the Phase II Primary Immunization Phase II and Sequential Booster Immunization Phase II studies in the United Arab Emirates.
The study showed that ReCOV was safe, well tolerated, had excellent immunogenicity, and had a clear cross-protective effect against Omicron variants (including the currently circulating strain BA4/5), and its performance was better than the data
reported by international mainstream epidemics.
The first batch of subjects enrolled in the international multi-center phase III clinical trial was recently completed
.
This clinical study is an international multicenter, randomized, double-blind, placebo-controlled phase III clinical trial
evaluating the protective efficacy and safety of ReCOV as a primary immunization in adult subjects aged 18 years and older.

In the first half of this year, the company carried out phase II studies
of primary immunization and sequential booster immunization in the Philippines and the United Arab Emirates, respectively.
The Philippines Primary Immunization Phase II recruits a blank population
that has not previously been vaccinated against the new crown vaccine.
The UAE Sequential Booster Phase II is aimed at people who have previously completed two or three doses of primary immunization against inactivated COVID-19 vaccine to evaluate the immunogenicity and safety
of ReCOV as a heterologous booster.

1.
ReCOV primary immunization and sequential booster immunization in the low-dose group and high-dose group showed good safety characteristics in the Asian population, and no serious adverse reactions related to the epidemic were reported SAE, and most of the adverse events related to vaccination were grade 1~2, and recovered
in the short term.

2.
ReCOV basic immunity can induce high levels of neutralizing antibodies
against the protovirus euvirus.
The peak neutralizing antibody after two doses can be as high as 4803.
4 IU/mL (converted by WHO standards), which is higher than the reported mRNA vaccine.

3.
ReCOV primary immunization and sequential booster immunization can induce high levels of neutralizing antibodies
against Omicron variants.
Compared with the prototype strain, the levels of neutralizing antibodies against Omicron BA.
2, BA.
4/5 and BA.
2.
75 decreased by about 1.
6~2 times, 2.
2~3.
5 times and 2.
6~3 times, respectively, and the decline was significantly lower than the published foreign mRNA disease data
.

4.
Compared with the subjects who received the third dose of inactivated epidemic seedlings as homologous booster immunization, the serum positive conversion rate SCR, geometric mean titer increase factor GMI, and average titer GMT of neutralizing antibody against the prototype strain and Omicron variant BA.
2, BA.
4/5, and BA.
2.
75 were greatly increased by ReCOV sequential booster immunization, and the average titer GMT of neutralizing antibody increased by 12.
1~17.
3 times
.

5.
The level of neutralizing antibodies detected based on true virus and pseudovirus methods is highly correlated
.
The pseudovirus neutralizing antibody test results in this study can be used as a reliable proxy for true virus neutralizing antibodies, which can be used to evaluate the immunogenicity of ReCOV in domestic and foreign clinical studies, and can be used for interracial immune bridging to support overseas clinical trial results for domestic declaration
.

ReCOV is a recombinant new crown pneumonia vaccine developed by the company using new adjuvants, protein engineering, immunoevaluation and other core technology platforms, and its adjuvant adjuvant adjuvant adjuvant is self-developed BFA03
.
ReCOV has a series of comprehensive advantages
such as strong broad-spectrum neutralizing antibody, obvious Th1-biased cellular immune response, good immune persistence, good overall safety, easy production scale-up, low production cost, good stability of preparations, and storage and transportation at room temperature.
The company has completed the construction of the ReCOV industrialization base and the preparation for commercial production, and has obtained the epidemic seedling production license issued by the Chinese regulatory authorities, making sufficient preparations
for commercialization in China.