TAIZHOU, China, Aug. 27, 2023 /PRNewswire/ -- Innovative vaccine company Recbio (02179.HK) announced its latest progress and interim results for 2023. During the reporting period, the company always adhered to the mission of " Protect Human Health With Best-In-Class Vaccines", rapidly promoted product research and development, and achieved the following milestones and progress in research pipeline and business operations.
Follow-up on the subjects of REC603's primary efficacy trial is being conducted in accordance with the clinical protocol. We have completed the 18th month follow-up visit and are conducting the 24th month follow-up visit observation.The Phase III clinical program is highly consistent with the guiding principles of the regulatory authorities, the sample size and the clinical site advantages are obvious.Currently, the Company is conducting follow-up visits according to the established protocol and is expected to accelerate the completion of case collection, maintaining the leading domestic position in the clinical development progress
The application for Chinese clinical trial of novel adjuvanted recombinant shingles vaccine REC610 has been officially accepted. Overseas phase I clinical progress is smooth, the overall safety and tolerability is good
We continuously strengthen the construction of independent intellectual property rights for innovative vaccines.We have applied for a number of invention patents related to respiratory syncytial virus vaccine (RSV),new novel adjuvants and other projects.
Cash and cash equivalents were approximately RMB 1.099 billion as of June 30, 2023, compared to RMB 1.325 billion as of December 31, 2022
Operating expenses (R&D and administrative expenses) for the first half of 2023 were approximately RMB 326 million .Compared to the first half of 2022, the reduction was approximately 24.41%
The loss during the period was approximately RMB 277 million, narrowed by 22.4% year-on-year
BUSSINESS HIGHLIGHTS
REC603-Recombinant HPV 9-valent Vaccine
HPV 9-valent vaccines can provide protection against 90% of cervical cancer and 90% of the anal and genital warts, being widely considered as the most effective vaccines against HPV-related diseases. Currently, no domestic HPV 9-valent vaccine has been approved for marketing in China.
We are in the process of conducting phase III clinical trial in China. The phase III clinical trial in China consists of three parts, i.e., the primary 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 placebo controlled design and with a total size of 16,050 subjects.
Follow-up on the subjects of REC603's primary efficacy trial is being conducted in
accordance with the clinical protocol. We have completed the 18th month follow-up visit and are conducting the 24th month follow-up visit observation. We plan to take the pathological endpoint for interim analysis and submit BLA application to the NMPA for REC603 after meeting the conditions.
The Company has completed the three doses vaccination in the two studies of REC603 immuno-bridging trial in the younger-age groups and the immunogenicity comparative trial with Gardasil®9.
The "Technical Guidelines for the Clinical Trials of Human Papillomavirus Vaccines (for Trial Implementation)" issued by the Center for Drug Evaluation of NMPA clearly states that "randomized, double-blind, placebo-controlled design is currently the best strategy to confirm the protective efficacy of first-generation vaccines." Our Phase III clinical protocol for the 9-valent HPV vaccine strictly follows the guidelines of the regulatory authorities; We have the largest HPV 9-valent Phase III clinical trial subjects in China and are conducting clinical trials in Henan, Shanxi and Yunnan provinces with high HPV infection rates. Currently, the Company is conducting follow-up visits according to the established protocol and is expected to accelerate the completion of case collection, maintaining the leading domestic position in the clinical development progress.
REC610 – Novel Adjuvanted Recombinant Shingles Vaccine
Shingles is an acute infectious skin disease caused by reactivation of latent varicella zoster virus (VZV) in the body. There is no specific medicine for shingles, and vaccine is an effective means of preventing shingles. According to research data on shingles vaccines that have been marketed around the world, the novel adjuvanted vaccine can provide stronger cellular immunity and protective efficacy as compared to live attenuated vaccines.
The Company has recently received the notice of acceptance (acceptance number:
CXSL2300518) issued by NMPA, pursuant to which the clinical trial application for its self-developed novel adjuvanted recombinant shingles vaccine REC610 has been accepted. The Company proposes to adopt a randomized, double-blind, Shingrix® parallel controlled phase I clinical trial in 180 healthy adult subjects aged 40 and above in Mainland China to evaluate the safety, tolerability of REC610 and have a preliminary assessment of its immunogenicity.
The Company commenced the first-in-human GSK Shingrix® active controlled clinical trial of REC610 in the Philippines in February 2023. Currently, the clinical trial is being executed smoothly. All subjects have completed 30 days of follow-up studies after two doses of the vaccination, with favorable safety and tolerability profile.
REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+T cells and antibody. Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE specific CD4+T cell responses and IgG antibody, and its immune response is non-inferior to the controlled vaccine Shingrix®.
ReCOV-Recombinant COVID-19 Vaccine
ReCOV is a recombinant COVID-19 vaccine being developed by the Company with its technology platforms, including its novel adjuvant, protein engineering and immunological evaluation platforms, and the adjuvant used therein is its self-developed novel adjuvant BFA03. It has a variety of comprehensive advantages, including favorable broad-spectrum of neutralizing antibodies 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.
For ReCOV international multi-center Phase III clinical trial, we have completed all subjects enrollment and full vaccination, and is currently under follow-up visit in accordance with the clinical protocol. We will analyze the endpoint of protective efficacy, and submit the application to the PRC regulatory authorities after meeting the conditions.
We obtained an emergency use authorization (EUA) for ReCOV in Mongolia in March 2023.
Others
We continuously strengthen the construction of independent intellectual property rights for innovative vaccines. Based on the protein engineering platform and mRNA technology platform, we have applied for a total of 15 invention patents related to antigens for respiratory syncytial virus vaccine (RSV),recombinant human herpes simplex virus vaccine (HSV), SARS-COV-2 and its variants projects. Based on the novel adjuvant platform, we applied for a total of 16 invention patents in the key raw materials of adjuvants, among which 1 novel adjuvant authorized patent was obtained.
In April 2023, the Company received the Reply of the Approval on the Registration of Shares Issued by Jiangsu Recbio Technology Co., Ltd. to Target Subscribers from the CSRC. The Reply should be valid for a period of 12 months from the date of approval.
In May 2023, the Company has been selected as a constituent of the MSCI China Small Cap Index, with effect from the close of market on May 31, 2023.
FINANCIAL HIGHLIGHTS
Cash and bank balances
Cash and cash equivalents were approximately RMB 1.099 billion as of June 30, 2023, compared to RMB 1.325 billion as of December 31, 2022.
R&D and administrative expenses
Operating expenses (R&D and administrative expenses) for the first half of 2023 were RMB 326 million .Compared to the first half of 2022, the reduction was approximately 24.41%.
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.
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Forward-looking statements
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