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New COVID-19 Vaccine Developed in China Receives Production License

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Jiangsu Recbio Technology Co., Ltd., a biopharmaceutical company focusing on the research, development and commercialization of innovative vaccines that can address prevalent diseases with significant burdens, recently announced that 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).

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It indicates that Recbio’s production facility in Taizhou, Jiangsu province, China (Taizhou facility) has been qualified to manufacture the recombinant two-component COVID-19 vaccine [CHO cell] (ReCOV), which signifies that Recbio has taken another significant step towards a vaccine enterprise with an entire industry chain cover research, production and marketing.         

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.

In the last 10 years, novel adjuvants had gradually been applied in the vaccine industry and brought profound changes to the industry. Recbio is one of the few companies with commercial production capability for novel adjuvants that have been approved by FDA for human use. Thanks to that, vaccines developed by the company not only have state-of-art performance, but also not rely on any particular adjuvant supplier. Equipped with an in-house developed novel adjuvant BFA03 benchmarking AS03, ReCOV has demonstrated excellent immunogenicity, safety, and tolerability in the Phase I clinical study in New Zealand. Notably, the titer of neutralizing antibodies induced by ReCOV was no less than that induced by the international mainstream mRNA vaccines. ReCOV is expected to apply for an EUA (Emergency Use Authorization) as early as the first half of 2022.

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 Delta. A series of comprehensive advantages such as better cross-protection against emerging variants, easy production scale-up, cost advantages, worldwide accessibility, good preparation stability, and storage and transportation at room temperature become a very competitive second-generation new COVID-19 vaccine.

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About the author

editor

Editor in chief is Linda Hohnholz.

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