Clinical Trial Approval For mRNA Covid-19 Vaccine For Omicron Variant In The Philippines

TAIZHOU, China, June 27, 2022 /PRNewswire/ -- Jiangsu Recbio Technology Co., Ltd. is pleased to announce that, the Group has recently received the clinical trial approval (the"Clinical Trial Approval") for its R520A, a mRNA COVID-19 vaccine ("R520A"), from the Food and Drug Administration of the Philippines.

R520A is an mRNA COVID-19 vaccine specifically targeting the Omicron variant developed by Wuhan Recogen Biotechnology Co., Ltd., a subsidiary of the Company. R520A adopts a self-developed lyophilization technology that can effectively sustain the physiochemical properties and bioactivity of mRNA-LNP and achieve long-term storage at 2℃–8℃. In the pre-clinical studies, the level of neutralizing antibody titers against Omicron variant increased to a high level of 4,758 and it can also induce neutralization response against Delta variant, indicating its promising immunogenicity profile. The relevant research results have been posted on the preprint server, bioRxiv.

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/.

About Recogen

Recogen is a holding subsidiary of Recbio which was founded in 2021. Recogen is a biotechnology company that combines the state of the art mRNA vaccine platform technology with new adjuvant technology. Headquartered in Wuhan, Recogen is a joint venture between Jiangsu Recbio Technology Co., Ltd and Shenzhen Rhegen Biotechnology Co. Ltd. Adhering to the strategy of "immunology embraces the central principle", Recogen has independently developed the platform technology required for the design, synthesis and evaluation of mRNA vaccines and applies the platform to the development of various infectious diseases vaccines.

Forward-looking statements

This Presentation 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.

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