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TAIZHOU, China, April 13, 2022 /PRNewswire/ -- Jiangsu Recbio Technology Co., Ltd. (the"Company", together with its subsidiaries, the "Group",Stock code:2179.HK) is pleased to announce that the Company has received approval from the Ministry of Health and Prevention of the United Arab Emirates ("UAE") ("Clinical Trial Approval") to conduct a Phase II/III clinical study of sequential booster vaccination for its recombinant protein COVID-19 vaccine ReCOV ("ReCOV") to evaluate the immunogenicity and safety of ReCOV as a heterologous booster in adult subjects.
This clinical trial is a multi-center, randomized, observer-blinded, active-controlled phase II/III study on persons who have previously completed two doses of inactivated COVID-19 vaccine for primary vaccination and whose last vaccination is 3 to 12 months away from heterologous booster of ReCOV. It is expected that approximately 1,950 adult subjects will be enrolled.
The study's safety and immunogenicity data are expected to be published in 2022, supporting the submission to the UAE Emergency Use Authorization (EUA) for ReCOV as a heterologous booster.
About Recombinant Two-Component COVID-19 Vaccine (ReCOV)
In May 2020, Recbio, together with Jiangsu Provincial Center for Disease Control and Prevention ("Jiangsu CDC") and Taizhou Medical New & High-tech Industrial Development Zone, jointly developed a recombinant two-component COVID-19 vaccine(ReCOV). Under the guidance of Professor Fengcai Zhu from the Jiangsu CDC, the R&D team thoroughly optimized the vaccine using protein engineering and new adjuvant technologies, so that ReCOV has promising safety and strong immunogenicity against SARS-CoV-2 and variants of concern such as Omicorn and Delta. A series of comprehensive advantages such as better cross-protection against emerging variants, easy scale-up of production, cost advantages, worldwide accessibility, good preparation stability, and storage and transportation at room temperature which become a very competitive second-generation new COVID-19 vaccine.
About Recbio
Founded in 2012, Recbio is an innovative vaccine company. With the vision of "Become the Leader of Innovative Vaccine in the Future," Recbio takes "Protect Human Health with Best-in-Class Vaccines" as its mission. It has established three major cutting-edge technology platforms including novel adjuvants platform, protein engineering platform, immunological evaluation platform and mRNA vaccine platform. Recbio has a high-value vaccine portfolio consisted of HPV vaccine candidates, COVID-19 vaccine candidates, shingles vaccine candidates, influenza vaccine candidates, adults TB vaccine candidates etc. The core management team has more than 20 years of experience in the development and commercialization of innovative vaccines. For more information, please visit https://www.recbio.cn/.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Recbio, are intended to identify certain of such forward-looking statements. Recbio does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Recbio with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Recbio's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Recbio's competitive environment and political, economic, legal and social conditions.
Jiangsu Recbio Technology Co., Ltd.
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