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TAIZHOU, China, April 11, 2022 /PRNewswire/ -- The board of directors of Jiangsu Recbio Technology Co., Ltd. (the "Company", together with its subsidiaries, the "Group",Stock code:2179.HK) is pleased to announce that, on April 9, 2022, the Company has received the European Union (EU) Qualified Person Declaration issued by a Qualified Person ("QP") for the Group's manufacturing facility for its recombinant protein COVID-19 vaccine, ReCOV ("ReCOV") in Taizhou, the People's Republic of China (the "PRC").
Pursuant to Eudralex Vol 4 regulations (EU Good Manufacturing Practice) and the guiding principles of International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Parenteral Drug Association (PDA) and International Society for Pharmaceutical Engineering (ISPE), etc., this EU QP audit mainly focused on the bulk and preparation of antigen and the novel adjuvant BFA03, covering manufacturing management system, quality management system, production equipment and facility management system, validation and computerized systems, material management systems, product testing and release management and other aspects of a comprehensive systematic and in-depth inspection. This signifies the Group's manufacturing facility in Taizhou and its quality management system have met EU GMP standards, laying a solid foundation for the high-quality development and future international commercialisation of ReCOV.
ReCOV is a recombinant COVID-19 vaccine being developed by the Group with its technology platforms including the novel adjuvant and protein engineering platforms. Based on the relevant studies conducted by the Group, ReCOV has shown favourable neutralizing effect and immune persistence against variants including Omicron variant and Delta variant. Clinical data from the Group's phase I trial for ReCOV in New Zealand also showed that it has an overall favorable safety profile and may potentially induce similar or higher level of neutralizing antibodies than other marketed mRNA COVID-19 vaccines and vaccine candidates.
About Recbio
Recbio is an innovative vaccine company founded in 2012. 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, and immunological evaluation 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/.
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.
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.
Investor Inquiry:
Email: ir@recbio.cn
Tel: +86-0523-86818860
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https://www.recbio.cn/
