The Philippines Has Approved ReCOV For Phase II/III Clinical Trial

18 January 2022 | Tuesday | News

The Philippines has approved Recombinant Two-Component COVID-19 Vaccine (ReCOV) developed by Jiangsu Recbio Technology Co., Ltd. ("Recbio") for Phase II/III clinical research. The trial is a global multicenter, randomized, double-blind, placebo-controlled study, to further evaluate the efficacy, safety, and immunogenicity of ReCOV in 18 years and older adult subjects. Recbio will complete the first enrollment of subjects soon. Recbio has submitted applications for Phase II/III clinical trials of ReCOV in several countries around the world.
Image Source : Public Domain

Image Source : Public Domain

  • Recombinant Two-Component COVID-19 Vaccine (ReCOV) was approved for International Phase II/III Clinical Trial
  • ReCOV induced high levels of neutralizing antibodies against SARS-CoV-2 and Variants of Concern such as Omicron and Delta
  • Rhecogen , a subsidiary focused on mRNA vaccines of the infectious diseases, launched the world's first lyophilized mRNA vaccine

"We are very pleased that the Philippines is the first country to approve the ReCOV for Phase II/III clinical research." said Dr. Liu Yong, Chairman and General Manager: " At present, to effectively cope with mutant strains of immune escape, it is urgent to accelerate the establishment of a strong immune barrier constructed by innovative COVID-19 vaccines. Based on ReCOV's strong Phase I immunogenicity and safety data, as well as good cross-neutralization against VOCs such as Omicron and Delta, we will accelerate international multi-center Phase II/III clinical development worldwide. "

Based on the antigen design concept guided by neutralizing antibodies, the ReCOV vaccine adopts the two-component antigen of NTD-RBD-Foldon, and adjuvanted with self-developed BFA03(an AS03-like squalene adjuvant), which has stronger immunogenicity and better neutralizing protective effect. Recbio previously announced the Phase I preliminary data of the ReCOV in New Zealand in November 2021. Overall, the preliminary data demonstrated that ReCOV were well tolerated and showed good safety profile, no SAE or TEAE leading to early discontinuation, no abnormal vital signs/laboratory testing results with clinical significance. After 1st dose of ReCOV vaccination, the seroconversion rate (SCR) of neutralizing antibodies was 100%. At 14 days after two doses of ReCOV, neutralizing antibody titers as high as 1643.2 IU/mL can be induced, and the level has reached the international leading level. ReCOV will be further evaluated for efficacy and safety in larger clinical trials soon.

A number of preclinical research have shown that the ReCOV has a good neutralization effect on various VOCs such as Omicron and Delta. The ReCOV vaccine has outstanding advantages in accessibility, it can be stable at room temperature for at least six months, and it is expected to be stable for at least 24 months under standard cold chain conditions, which makes ReCOV suitable for delivery in hot climates and limited cold chain logistics conditions. Large-scale vaccination in resource-limited countries and regions can effectively solve the problem of uneven distribution of vaccines.

Due to the use of self-developed novel adjuvants and no need to rely on specific suppliers, ReCOV is significantly cost-effective and has a good supply base for production. In November 2021, the company has received the Pharmaceutical Production License (scope: recombinant two-component COVID-19 vaccine [CHO cell]) issued by the Jiangsu Medical Products Administration(JSMPA). The newly constructed state-of-art production facility was designed following the current Good Manufacturing Practices (cGMP) standards. With a total GFA of over 17,000 sq.m., Taizhou facility has an annual production capacity of more than 100 million doses, which can quickly be expanded to 300 million doses per year.

The world's first lyophilized mRNA vaccine, effective against Omicron mutants

At present, the two mRNA vaccines most widely used in the world must be stored and transported in extremely harsh ultra-low temperature from bottling to the moment before inoculation. In response to the lack of accessibility of existing mRNA vaccines, Rhecogen , which was jointly established by Recbio and Rhegen, has taken the lead in completing the research on lyophilized dosage forms, and the product can be stored and transported under conventional cold chain or even room temperature conditions. Studies have shown that the physicochemical properties and biological activity of the product remain consistent before and after lyophilization. We will submit a clinical trial application for the lyophilized mRNA vaccine against the Omicron variant to the regulatory agencies as soon as possible.


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