Acceptance Of The Application For Clinical Trial Of Recbio Novel Adjuvanted Recombinant Quadrivalent HPV Vaccine

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Oct 27, 2022, 22:52 ET

TAIZHOU, China, Oct. 27, 2022 /PRNewswire/ -- Jiangsu Recbio Technology Co., Ltd. (the "Company", together with its subsidiaries, the "Group") is pleased to announce that, the Group has recently received a notice of acceptance from the National Medical Products Administration to accept the application for a clinical trial of in-housed developed novel adjuvanted recombinant quadruvalent HPV vaccine, REC604a.

The REC604a is equipped with the novel adjuvanted BFA04 independently developed by the Company, which aims to reduce the dose of vaccination by enhancing the immunogenicity and cross-protection effects. Reducing dose number helps save costs and increase vaccination rates, which is recommended by regulatory agencies such as the WHO. Preclinical studies have shown that the BFA04 adjuvant enhances the neutralizing antibodies by 7.7 times when compared with using an aluminum adjuvant. Compared with three-shot of HPV vaccine Gardasil, the levels of HPV neutralizing antibodies induced by two-shot of REC604a were higher than those induced by three-shot of Gardasil. In 24 weeks after the last immunization procedure, the decreasing trend of neutralizing antibody titer induced by REC604a was slower than that induced by Gardasil.

The notice of acceptance of the clinical trial for REC604a further indicates the Company's leading strength in the field of novel adjuvanted vaccines, enhances the Company's core competitiveness and market position, and is expected to provide a better prevention option for accelerating the increase of HPV vaccination rate in China.

In accordance with Article 32 of the Administrative Licensing Law of the People's Republic of China, it is decided to accept it upon examination. Within 60 days from the date of acceptance, if no negative or questioning opinion is received from the Center for Drug Evaluation, the Company may carry out clinical trials in accordance with the submitted plan.

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.

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