Recbio announces Phase III Clinical Trial Progress Of Recombinant HPV 9-Valent Vaccine
TAIZHOU, China, Aug. 10, 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 completed the subject enrollment and first dose vaccination in respect of immuno-bridging study of its recombinant HPV 9-valent vaccine, REC603, in younger-age groups and the study to compare the immunogenicity between REC603 and Gardasil® 9. At the same time, follow-up on the subjects of REC603's efficacy trial is being conducted in accordance with the clinical protocol.
The phase III clinical trial of REC603 in China consists of three parts, i.e. the efficacy trial, the immuno-bridging trial in younger-age groups, and the immunogenicity comparative trial with Gardasil® 9, with a multi-center, randomized, blinded and parallel controlled design and with a total size of 16,050 subjects:
- Efficacy trial: To evaluate the protective efficacy of the vaccines in healthy female subjects aged 18 to 45 against high-risk HPV infection-related high-grade cervical, vulvar, vaginal high-grade intraepithelial neoplasia and above lesions.
- Immuno-bridging trial in younger-age groups: To evaluate the non-inferiority of serum virus neutralizing antibodies in healthy female subjects aged 9 to 17 as compared with healthy female subjects aged 18 to 45 at one month after full-course vaccination with the experimental vaccines.
- Immunogenicity comparative trial with Gardasil® 9: To evaluate the non-inferiority of serum virus neutralizing antibodies in healthy female subjects aged 16 to 26 as compared with Gardasil® 9 at one month after full-course vaccination with the experimental vaccines.
HPV 9-valent vaccines can prevent approximately 90% of cervical cancers and 90% of anal and genital warts, and is widely regarded as the most effective vaccine against HPV infections. At present, no domestic HPV 9-valent vaccine has been approved for sale in China. Completed Phase I clinical data of REC603 shows that it is safe and well tolerated with favorable immunogenicity profile. REC603 adopts H. polymorpha expression system to achieve high-yield and stable expression of HPV virus-like particles and to make the Company's vaccine candidate more suitable for commercial production. With well-defined critical process parameters and control strategies, manufacturing of REC603 can be easily scaled-up to meet the market demand domestically and globally.
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 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.
SOURCE: Jiangsu Recbio Technology Co., Ltd.
SOURCE Jiangsu Recbio Technology Co., Ltd.
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