The MHLW has granted marketing & manufacturing authorization for Libtayo as monotx. for cervical cancer whose disease progressed after CT
TAIZHOU, China, Dec. 25, 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 sequential booster vaccination Phase II study of the recombinant two-component COVID-19 vaccine ReCOV in the Philippines. This clinical study aims to compare the immunogenicity and safety profile of ReCOV and Pfizer's mRNA vaccine COMIRNATY®as booster vaccination among subjects who have completed primary vaccination of inactivated vaccines. The results showed that neutralizing antibody titer levels against Omicron BF.7 and BA.2.75 induced by sequential vaccination of ReCOV were significantly better than those of the mRNA vaccine group (with significant differences statistically).
The main strain of the current outbreak in Beijing is Omicron BF.7. As a variant of Omicron, BF.7 has a stronger immune escape ability, faster infection rate, and stronger concealment. Therefore, vaccination of vaccines with better efficacy is key to ending the epidemic.
1. Statistically superior neutralizing antibody titer levels against Omicron BF.7 compared to the mRNA vaccine. Upon 14 days after booster vaccination, the seroconversion rate (SCR) of neutralizing antibody against Omicron BF.7 of the ReCOV group and the mRNA vaccine group were 91.1% and 88.4%, respectively, and the SCR of the ReCOV group was higher than that of the mRNA vaccine group . At the same time, the geometric mean titers (GMT) of neutralizing antibodies in the ReCOV group and the mRNA vaccine group were 6,549.1 and 4,529.6, respectively, and the GMT in the ReCOV group was significantly higher than that in the mRNA vaccine group (P value < 0.001). In addition, the neutralizing antibody level induced by the ReCOV group increased by 30.8 times compared with the baseline, which was significantly higher than that of the mRNA vaccine (22.7 times). In the ReCOV group, the neutralizing antibody against Omicron BF.7 was only 2.5 times lower than that of the original strain, showing excellent cross-neutralization effect.
2. Statistically superior neutralizing antibody titer levels against Omicron BA.2.75 compared to the mRNA vaccine. Upon 14 days after booster vaccination, the SCR of neutralizing antibody against Omicron BA.2.75 of the ReCOV group and the mRNA vaccine group were 92.1% and 88.4%, respectively, and the SCR value of the ReCOV group was higher than that of the mRNA vaccine group. At the same time, the neutralizing antibody GMT of the ReCOV group and the mRNA vaccine group were 6,268.3 and 4,676.3, respectively, and the GMT of the ReCOV group was significantly higher than that of the mRNA vaccine group (P value = 0.003). In addition, the neutralizing antibody induced by the ReCOV group increased by 27.3 times compared with the baseline, which was significantly higher than that of the mRNA vaccine (21.5 times). In the ReCOV group, the neutralizing antibody against Omicron BA.2.75 was only 2.6 times lower than that of the original strain, showing excellent cross-neutralization effect.
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 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.
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/.
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.
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PR Source:- Prnewswire