Two-Component Recombinant COVID-19 Vaccine ReCOV Granted With Emergency Use Authorization In Mongolia
Jiangsu Recbio Technology Co., Ltd. (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that in accordance with the Mongolian law on the prevention of novel coronavirus (SARS-CoV-2) outbreak, the Company was granted an Emergency Use Authorization (“EUA”) for its two-component recombinant COVID-19 vaccine ReCOV by Order No. A106 of the Minister of Public Health of Mongolia and a resolution of the Mongolian Committee for Medicinal Products for Human Use. This product is designed and developed by the Group jointly with Professor Wang Xiangxi’ s group at the Institute of Biophysics, Chinese Academy of Science, and is the first novel adjuvant recombinant subunit COVID-19 vaccine developed in China and approved overseas.
Novel adjuvant have become a key factor in the successful research and development of innovative vaccines in China, and have become one of the key research projects in the development plan of China’s pharmaceutical industry during the 14th Five-Year Plan. ReCOV is a recombinant COVID-19 vaccine being developed by the Company with its technology platforms, including its novel adjuvant, protein engineering and immunological evaluation platforms, and the adjuvant used therein is its self-developed novel adjuvant BFA03. The Company has successively conducted multiple late-stage clinical studies for ReCOV in China, the Philippines, the United Arab Emirates, Nepal and Russia. Studies have shown that ReCOV has demonstrated favorable safety profile, with mild adverse reactions and no vaccine-related serious adverse events. In particular, in a comparative clinical study with a positive control of the Pfizer’s mRNA vaccine, a sequential booster of ReCOV among subjects who have completed vaccination of inactivated vaccines induced durable and widespread cross-neutralizing antibodies against various Omicron variants, including BF.7, BA.5, BA.2.75, and BA.2, with all subgroups achieving superior levels of neutralizing antibodies as compared to the Pfizer’s mRNA vaccine (with statistically significant differences).
The granting of the EUA to ReCOV in Mongolia will benefit the Group’s expansion into overseas market, enhancement of the Group’s overseas brand awareness and promotion of the Group’s
internationalization strategy, and will play a positive role in promoting the registration in other countries and regions.
Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereinafter referred to as Recbio or the Company; stock code: 02179.HK) is an innovative vaccine company driven by self-developed technologies. We are dedicated to the R&D, production and commercialization of innovative vaccines, leveraging our core technology platforms (novel adjuvant, protein engineering, immunological evaluation). Staying true to the mission of “Protect human health with best-in-class vaccines”, the Company has established high-value pipelines consisting of several blockbuster vaccines with proprietary rights to satisfy the huge unmet demands in the markets of high-burden diseases.
Through years of devotion to the vaccine industry, Recbio has developed three advanced innovative technology platforms, namely novel adjuvant, protein engineering and immunological evaluation platforms, and become one of the few companies in the world capable of developing novel adjuvant systems. We develop promising vaccine candidates constantly, taking advantage of the synergy between the novel adjuvant platform, optimized antigen designs, and immunological evaluation technologies. Recbio never ceases to optimize its technology platforms, and strives to achieve breakthroughs in mRNA vaccines using a joint venture model.
With robust R&D capacity, the Company has developed high-value innovative vaccine portfolios consisting of ten-odd differentiated vaccines, covering cervical cancer, shingles, COVID-19, TB and other high-burden diseases. Our core product REC603, a recombinant 9-valent HPV vaccine in Phase III clinical trial, shows great promise of becoming the first marketed domestic 9-valent HPV vaccine. Apart from that, ReCOV, a recombinant COVID-19 vaccine with its commercialization in the offing, has been recognized as one of the most competitive next-generation COVID-19 vaccines in the world. Recbio has a clear commercialization strategy aiming to penetrate the diversified global vaccine market.
Honed and refined for ten years, Recbio is going to reap the rewards as several products are approaching commercialization.
For more information, please visit https://www.recbio.cn/.
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