Two-Component Recombinant COVID-19 Vaccine ReCOV Granted With Emergency Use Authorization In Mongolia

Published: Mar 21, 2023

TAIZHOU, China, March 21, 2023 /PRNewswire/ -- 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 has become a key factor in the successful research and development of innovative vaccines in China, and has 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.

About Recbio

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/.

Forward-looking statements

This Press Release may contain projections, estimates, forecasts, targets, opinions, prospects, results, returns and forward-looking statements with respect to the financial condition, results of operations, capital position, strategy and business of the Group which can be identified by the use of forward-looking terminology such as "may", "will", "should", "expect", "anticipate", "project", "plan", "estimate", "seek", "intend", "target", "believe", "potential" and "reasonably possible" or the negatives thereof or other variations thereon or comparable terminology (collectively, "forward-looking statements"), including the strategic priorities, research and development projects, and any financial, investment and capital targets and any other targets, commitments and ambitions described in writing or verbally herein. Any such forward-looking statements are not a reliable indicator of future performance, as they may involve significant stated or implied assumptions and subjective judgements which may or may not prove to be correct, accurate or complete. There can be no assurance that any of the matters set out in the forward-looking statements are attainable, will actually occur or will be realised or are complete or accurate. The assumptions and judgments may prove to be incorrect, inaccurate or incomplete, and involve known and unknown risks, uncertainties, contingencies and other important actors, many of which are outside the control of the Group. There is also no assurance that the Group may develop or market its core products or other pipeline candidates successfully. Actual achievements, results, performance or other future events or conditions may differ materially from those stated, implied and/or reflected in any forward-looking statements due to a variety of risks, uncertainties and other factors (including without limitation general market conditions, regulatory changes, geopolitical tensions or data limitations and changes). Any such forward-looking statements are based on the beliefs, expectations and opinions of the Group at the date the statements are made, and the Group does not assume, and hereby disclaims, any obligation or duty to update, revise or supplement them if circumstances or management's beliefs, expectations or opinions should change. For these reasons, you should not place reliance on, and are expressly cautioned about relying on, any forward-looking statements. No representations or warranties, expressed or implied, are given by or on behalf of the Group as to the achievement or reasonableness of any projections, estimates, forecasts, targets, commitments, prospects or returns contained herein.

Please refer to the announcements published by the Company on the websites of The Stock Exchange of Hong Kong Limited (www.hkexnew.hk) or of the Company (www.recbio.cn) for further details. If there is any inconsistency between this Presentation and the announcements, the announcements shall prevail.

Jiangsu Recbio Technology Co., Ltd.

Investor Inquiry:
Email: ir@recbio.cn
Tel: +86-0523-86818860

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Email: media@recbio.cn
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Two-Component Recombinant COVID-19 Vaccine ReCOV Granted With Emergency Use Authorization In Mongolia