Clinical Trial Approval For ReCOV In The PRC And The Overseas Clinical Trial Progress Of ReCOV
TAIZHOU,China,May 5,2022 -- Jiangsu Recbio Technology Co.,Ltd. (the"Company",together with its subsidiaries,the "Group",Stock code:2179.HK) is pleased to announce that the Company has recently received the clinical trial approval (the "Clinical Trial Approval") for its recombinant protein COVID-19 vaccine,ReCOV ("ReCOV"),from National Medical Products Administration ("NMPA") of the People's Republic of China (the "PRC").
As disclosed in the prospectus of the Company dated March 21,2022,the Group had initiated subject enrollment for the phase II/III clinical trial for ReCOV in the Philippines. As of the date of this announcement,subject enrollment for the phase II trial for ReCOV in the Philippines and twoshot dosing for all such subjects had been completed,demonstrating a favourable safety profile of ReCOV based on the relevant safety data.
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 may potentially induce similar or higher level of neutralizing antibodies than other marketed mRNA COVID-19 vaccines and other vaccine candidates.
About Recombinant Two-Component COVID-19 Vaccine (ReCOV)
Recombinant two-component COVID-19 vaccine (CHO Cell) is a combination of new adjuvants,protein engineering and other technology platform to thoroughly optimize the vaccine,ReCOV has a series of comprehensive advantages,such as good safety,strong immunogenicity,good cross-protection effect against the current popular mutants in the world,easy production,low production cost,good stability of preparation,storage and transportation at room temperature and so on,making it a very competitive new generation of COVID-19 vaccine.
About Recbio
Founded in 2012,Recbio is an innovative vaccine company. 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,immunological evaluation platform and mRNA vaccine 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.
Jiangsu Recbio Technology Co.,Ltd.
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