Approval Of The Comparative Study Between ReCOV And mRNA Vaccines By FDA In The Philippines

August 3, 2022 |

4 min read

Jiangsu Recbio Technology Co., Ltd. is pleased to announce that, the Company has recently received the clinical trial approval for its recombinant protein COVID-19 vaccine, ReCOV from the Food and Drug Administration of the Philippines.

TAIZHOU, China, Aug. 3, 2022 /PRNewswire/ -- Jiangsu Recbio Technology Co., Ltd. (the"Company”, together with its subsidiaries, the “Group”,Stock code:02179.HK) is pleased to announce that, the Company has recently received the clinical trial approval for its recombinant protein COVID-19 vaccine, ReCOV from the Food and Drug Administration of the Philippines, approving the Company to conduct a randomized, blinded, active-controlled Phase II clinical trial of ReCOV on healthy subjects aged 18 years or above who have received primary vaccination with two doses of an inactivated COVID-19 vaccine to compare the immunogenicity and safety between ReCOV and Pfizer’s mRNA vaccine COMIRNATY^®. The Company plans to commence clinical enrollment in the near future.

ReCOV is a recombinant COVID-19 vaccine being developed by the Company with its technology platforms including the novel adjuvant and protein engineering platforms, and the adjuvant used therein is the Company’s self-developed novel adjuvant BFA03. Based on the relevant studies conducted by the Company, ReCOV can induce high titers of neutralizing antibody and Th1 biased cellular immune responses, and has shown favorable neutralizing effect and immune persistence against variants including Omicron variant and Delta variant. It has a variety of comprehensive advantages, including overall positive safety profile, potential growth in production scale, low production cost, preparation stability, and ability to be stored and transported at room temperature.

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

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