The Philippines Has Approved ReCOV For Phase II/III Cinical Trial

The Philippines has approved Recombinant Two-Component COVID-19 Vaccine (ReCOV) developed by Jiangsu Recbio Technology Co., Ltd. ("Recbio") for Phase II/III clinical research. The trial is a global multicenter, randomized, double-blind, placebo-controlled study, to further evaluate the efficacy, safety, and immunogenicity of ReCOV in 18 years and older adult subjects. Recbio will complete the first enrollment of subjects soon. Recbio has submitted applications for Phase II/III clinical trials of ReCOV in several countries around the world.

"We are very pleased that the Philippines is the first country to approve the ReCOV for Phase II/III clinical research." said Dr. Liu Yong, Chairman and General Manager: " At present, to effectively cope with mutant strains of immune escape, it is urgent to accelerate the establishment of a strong immune barrier constructed by innovative COVID-19 vaccines. Based on ReCOV's strong Phase I immunogenicity and safety data, as well as good cross-neutralization against VOCs such as Omicron and Delta, we will accelerate international multi-center Phase II/III clinical development worldwide. "

Based on the antigen design concept guided by neutralizing antibodies, the ReCOV vaccine adopts the two-component antigen of NTD-RBD-Foldon, and adjuvanted with self-developed BFA03（an AS03-like squalene adjuvant）, which has stronger immunogenicity and better neutralizing protective effect. Recbio previously announced the Phase I preliminary data of the ReCOV in New Zealand in November 2021. Overall, the preliminary data demonstrated that ReCOV were well tolerated and showed good safety profile, no SAE or TEAE leading to early discontinuation, no abnormal vital signs/laboratory testing results with clinical significance. After 1st dose of ReCOV vaccination, the seroconversion rate (SCR) of neutralizing antibodies was 100%. At 14 days after two doses of ReCOV, neutralizing antibody titers as high as 1643.2 IU/mL can be induced, and the level has reached the international leading level. ReCOV will be further evaluated for efficacy and safety in larger clinical trials soon.

A number of preclinical research have shown that the ReCOV has a good neutralization effect on various VOCs such as Omicron and Delta. The ReCOV vaccine has outstanding advantages in accessibility, it can be stable at room temperature for at least six months, and it is expected to be stable for at least 24 months under standard cold chain conditions, which makes ReCOV suitable for delivery in hot climates and limited cold chain logistics conditions. Large-scale vaccination in resource-limited countries and regions can effectively solve the problem of uneven distribution of vaccines.

Due to the use of self-developed novel adjuvants and no need to rely on specific suppliers, ReCOV is significantly cost-effective and has a good supply base for production. In November 2021, 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). 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.

The world's first lyophilized mRNA vaccine, effective against Omicron mutants

At present, the two mRNA vaccines most widely used in the world must be stored and transported in extremely harsh ultra-low temperature from bottling to the moment before inoculation. In response to the lack of accessibility of existing mRNA vaccines, Rhecogen , which was jointly established by Recbio and Rhegen, has taken the lead in completing the research on lyophilized dosage forms, and the product can be stored and transported under conventional cold chain or even room temperature conditions. Studies have shown that the physicochemical properties and biological activity of the product remain consistent before and after lyophilization. We will submit a clinical trial application for the lyophilized mRNA vaccine against the Omicron variant to the regulatory agencies as soon as possible.

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

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/.

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.