Recbio Receives Pharmaceutical Production License from Jiangsu Medical Products Administration for Production of COVID-19 Vaccine

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 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.

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 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. 

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.

Source: Jiangsu Recbio Technology Co., Ltd.