Update on overseas clinical trials progress of novel adjuvant COVID-19 vaccine ReCOV

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Nov 08, 2022, 02:10 ET

TAIZHOU, China, Nov. 8, 2022 /PRNewswire/ -- Jiangsu Recbio Technology Co., Ltd. (the "Company", together with its subsidiaries, the "Group") is pleased to announce that positive results were achieved for its primary vaccination Phase II study in the Philippines and heterologous booster vaccination Phase II study in United Arab Emirates ("UAE") in respect of its recombinant COVID-19 vaccine ReCOV. The studies showed that ReCOV had demonstrated good safety profile and excellent immune response and was able to provide definite cross-protection from the Omicron variants (including the epidemic strain BA4/5), outperforming the international mainstream vaccines reported to date. The Company has recently completed the first batch of subject enrollment for the international multi-center phase III clinical trial of recombinant COVID-19 vaccine ReCOV. This phase III clinical trial is an international multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ReCOV as primary vaccination in adults aged 18 years and above.

In the first half of this year, the Company initiated its primary vaccination Phase II study on ReCOV in the Philippines and heterologous booster vaccination Phase II study on ReCOV in UAE, respectively. For the Phase II study in the Philippines, the study population was previously naïve to COVID-19 vaccines; and for the Phase II study in UAE, the participants were those who had received two or three doses of inactivated vaccine before the study enrollment to evaluate the immunogenicity and safety of ReCOV as a heterogenous booster.

1. A good safety profile has been demonstrated among Asian population for both the primary and heterologous booster vaccination with low-dose and high-dose ReCOV, and no vaccinerelated serious adverse event has been reported, with a majority of vaccination-related adverse events falling between Grade 1 and Grade 2 in severity, and most of the subjects recovered within a short period of time.

2. Primary vaccination with ReCOV could induce high level of neutralizing antibodies against the prototype strain live-virus, and the highest level of neutralizing antibody after two doses of vaccination could reach 4,803.4 IU/mL (converted with WHO standard units), which exceeded that of the reported mRNA vaccines.

3. Both the primary vaccination and heterologous booster vaccination with ReCOV could induce high level of neutralizing antibodies against the Omicron variants. Compared with the prototype strain, the level of neutralizing antibodies against Omicron BA.2, BA.4/5 and BA.2.75 only dropped by approximately 1.6-2 times, 2.2-3.5 times and 2.6-3 times, respectively, and such level of decrease was significantly lower than that of mRNA vaccines.

4. Compared with the subjects who received the third shot of inactivated vaccine as a homologous booster, the SCR and GMI of neutralizing antibodies against both the prototype strain and Omicron BA.2, BA.4/5 and BA.2.75 induced by ReCOV heterologous booster vaccination were significantly higher, with the GMT of neutralizing antibodies increased by approximately 12.1-17.3 times.

5. There is a strong correlation between the levels of neutralizing antibodies detected based on the live-virus and pseudovirus testing methodologies. The test results of the pseudovirus neutralizing antibodies in this study can be used as a reliable alternative indicator for the livevirus neutralizing antibodies, to evaluate the immunogenicity in clinical studies of ReCOV carried out in China and globally and support inter-ethnic immune-bridging, and to support the regulatory application in China.

ReCOV is a recombinant COVID-19 vaccine being developed by the Company with its technology platforms including the novel adjuvant, protein engineering and immunological evaluation platforms, and the adjuvant used therein is the self-developed novel adjuvant BFA03. It has a variety of comprehensive advantages, including inducing high titers of neutralizing antibody and Th1 biased cellular immune response, favourable neutralizing effect and immune persistence, overall positive safety profile, potential growth in production scale, low production cost, preparation stability, and ability to be stored and transported at room temperature.The Company has completed the construction of ReCOV manufacturing facility and preparation for commercial production, and has obtained the relevant vaccine production license issued by the regulatory authorities in China, which is fully prepared for commercialization in China.

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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