BUSINESS: Recbio Receives A Pharmaceutical Production License From Jiangsu Medical Products Administration To Produce COVID-19 Vaccine

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by Daniel Webster, dWeb.News Publisher

TAIZHOU, China, Nov. 16, 2021 /PRNewswire/ — Jiangsu Recbio Technology Co., Ltd. (“Recbio”), 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). 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 new state-of-the-art production facility was built in accordance with current Good Manufacturing Practices standards (cGMP). It has a total GFA of over sq.m., which means that Recbio is making another significant step towards becoming a vaccine enterprise. 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 the only company that has commercial production capabilities for novel adjuvants. FDA approved Recbio for human use. Recbio’s vaccines are not only state-of the-art but also do not depend on any 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. ReCOV produced a titer of neutralizing antibody that was equal to the one produced by international mainstream mRNA vaccinations. 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). The Jiangsu CDC Professor Fengcai Zhu led the R&D team to optimize the vaccine by using protein engineering and novel adjuvant technologies. ReCOV is a promising vaccine that has strong immunogenicity and safety against SARS-CoV-2 variants 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.

About Recbio

Recbio is an innovative vaccine company founded in 2012. Recbio was founded in 10 with the vision to “Become the Leader of Innovative Vaccines in the Future”. Recbio has three key technology platforms that are cutting-edge, including a novel adjuvants platform and a protein engineering platform. It also offers an immunological evaluation platform. Recbio has a high-value vaccine portfolio consisting of HPV vaccine candidates, COVID-19 vaccine candidates, shingles vaccine candidates, influenza vaccine candidates, adults TB vaccine candidates, etc. The core scientific 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. Recbio uses the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, and similar expressions to identify forward-looking statements. Recbio will not update forward-looking statements on a regular basis.

These forward-looking statements are based upon the current beliefs, assumptions and expectations of Recbio’s management with respect to future events. These statements do not guarantee future developments. They are subject to uncertainties, risks and other factors that are hard to predict and beyond Recbio’s reach.

-05232022Media Inquiry: 200Tel: + 2022

Jiangsu Recbio Technology Co., Ltd.

Investor Inquiry:
Email: [email protected]
Tel: +86-0523-86818860

Media Inquiry:
Email: [email protected]
Tel: +86-0523-86818860

SOURCE Jiangsu Recbio Technology Co., Ltd.

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