TaizhouAugust 28, 2023/ PR Newswire /-innovative vaccine company 02179.HK has released its 2023 interim results report and latest developments. The company has always adhered to the mission of "creating first-class vaccines and protecting human health". During the reporting period, we rapidly promoted product research and development and reached the following milestones and progress in pipeline research and business operations.

• RecombinationHPVNine-valent vaccineREC603The main efficacy trial study is carrying out regular follow-up work in accordance with the clinical plan, and the first part has been completed.eighteenA six-month visit, which is in progresstwenty-fourMonths of visit and observation. TheIIIThe phase clinical plan is highly consistent with the guiding principles of the regulatory department, and the sample size is leading, and the clinical field has obvious advantages. Compared with before, it is expected to speed up the completion of case collection and maintain the domestic leading progress of clinical development.
• Application for clinical trials of new adjuvant recombinant herpes zoster vaccine in China has been formally accepted; overseasIThe clinical progress is smooth, and the overall safety and tolerance are good.
• We will continue to strengthen the distribution of independent intellectual property rights of innovative vaccines. In the respiratory syncytial virus vaccine (RSV) and new adjuvants and other projects to apply for a number of invention patents
• As of2023YearsixMonththirtyCash and cash equivalents are about RMB10.99100 million yuan, and as of2022YeartwelveMonththirty-oneRMB per day13.25100 million yuan
• Vs.2022Compared with the first half of 20002023Operating expenses in the first half of the year(Research and development and administrative expenditure)For RMB3.26100 million yuan, a reduction of about24.41%
• The loss during the period is about RMB2.77100 million yuan, narrowing compared with the same period last year22.4%

Business summary

REC603-reorganizationHPVNine-valent vaccine

Nine-valent HPV vaccine can prevent about 90% of cervical cancer and 90% of anal and genital warts, and is widely considered to be the most effective vaccine against HPV. At present, no domestic nine-valent HPV vaccine has been approved for sale in China.

• We are conducting a phase III clinical trial of REC603 China. The test consists of main efficacy test, young age group immune bridging test, and Gardasil.9 Immunogenicity comparison test was composed of three parts, using multicenter, random, blind, placebo-controlled design, with a total sample size of 16050 subjects.
• The main efficacy trial study is conducting regular follow-up in accordance with the clinical protocol. We have completed the 18th month visit and are conducting the 24th month visit observation. We will take the pathological end point for interim analysis and submit the BLA application when the conditions are met.
• Immune bridging and Gardasil in young age group9 comparison of immunogenicity the three-dose vaccination of the two studies has been completed.
• The "Technical guidelines for Clinical Trials of Human Papillomavirus Vaccine (trial)" issued by the Drug Review Center of the State Drug Administration clearly points out that "randomized, double-blind, placebo-controlled design is the best strategy to confirm the protective effectiveness of the first generation vaccine." Our nine-valent HPV vaccine phase III clinical program strictly follows the guidelines of regulatory authorities; we have the largest sample size of III phase 9 clinical trials in Henan, Shanxi and Yunnan provinces with high HPV infection rates. At present, the company is visiting according to the established plan and is expected to complete the case collection faster than before, so as to keep the domestic leading progress of clinical development.

REC610New adjuvant recombinant herpes zoster vaccine

Herpes zoster is an acute infectious skin disease caused by reactivation of varicella-zoster virus (VZV) latent in the body. There is no specific cure for herpes zoster, vaccination is an effective means to prevent herpes zoster. According to the global research data of herpes zoster vaccine, the new adjuvant vaccine can provide stronger cellular immunity and protective effect than live attenuated vaccine.

• The company has received the acceptance notice (acceptance number: CXSL2300518) issued by the State Drug Administration and agreed to accept the application for clinical trials of its new adjuvant recombinant herpes zoster vaccine REC610. The company plans to adopt random, double-blind, ShingrixIn a parallel control design, 180 healthy subjects aged 40 and over were recruited to conduct phase I clinical trials in China to evaluate the safety, tolerance and immunogenicity of REC610.
• The company has conducted the first human trial of REC610 with GlaxoSmithKline PLC Shingrix as a positive control in the Philippines in February 2023. At present, the study is progressing smoothly, all subjects have completed a 30-day follow-up after two doses of vaccine vaccination, and the safety and tolerance are good.
• REC610 is equipped with a new adjuvant BFA01 developed by our company, which can promote the production of high levels of VZV glycoprotein E (gE) specific CD4+T cells and antibodies. Preclinical studies have shown that REC610 has good immunogenicity and can induce high levels of gE antigen specific CD4+T cell reaction and IgG antibody, and its immune response is not inferior to that of the control vaccine Shingrix..

ReCOVRecombinant two-component novel coronavirus vaccine

ReCOV is a recombinant novel coronavirus vaccine developed by our company using new adjuvants, protein engineering, immune evaluation and other core technology platform, and its adjuvant is a new adjuvant BFA03 developed by ourselves. ReCOV vaccine has a series of comprehensive advantages, such as strong broad spectrum of neutralizing antibody, good immune persistence, good overall safety, easy to scale up, low production cost, good preparation stability, and can be stored and transported at room temperature.

• The ReCOV international multicenter phase III clinical trial has completed all subjects' enrollment and full vaccination. Follow-up work is being carried out in accordance with the clinical plan. We will analyze the end point of protective efficacy and submit the listing application to the regulatory authorities in China after meeting the conditions.
• In March 2023, ReCOV was authorized for emergency use in Mongolia.

Other matters

• We will continue to strengthen the distribution of independent intellectual property rights of innovative vaccines. Based on the protein engineering platform and mRNA technology platform, we have applied for 15 invention patents related to antigens for respiratory syncytial virus vaccine (RSV), recombinant human herpes simplex virus vaccine (HSV), SARS-COV-2 and their variants. Based on the new adjuvant platform, we have applied for 16 invention patents in the key raw materials of adjuvants, of which one new adjuvant patent has been granted.
• In April 2023, the company's targeted issuance of domestic shares was approved by the China Securities Regulatory Commission. The reply is valid for 12 months from the date of consent to registration.
• In May, 2023, the company was selected to be included in the MSCI China small cap index, effective after the market closes on May 31, 2023.

Financial summary

Cash and bank balance

As of June 30, 2023, cash and cash equivalents were about 1.099 billion yuan, while as of December 31, 2022, it was 1.325 billion yuan.

Research and development and administrative expenditure

Compared with the first half of 2022, operating expenditure (R & D and administrative expenditure) in the first half of 2023 was 326 million yuan, a decrease of about 24.41 per cent compared with the same period last year.

Dr. Liu Yong, founder, Chairman and General Manager of Ruike Biology, said: "in 2023, the company has always adhered to the mission of 'creating first-class vaccines and protecting human health' and focused on strategic pipelines. We will speed up the R & D and commercial preparation of key varieties; continue to improve the technology platform and management capabilities, enhance the company's potential for development, and the company has made remarkable progress in all aspects of management. Looking forward to the second half of 2023, we will, as always, strengthen the innovative research and development of core technologies and key varieties, and accelerate management change. At the same time, we will strive to expand cooperation at home and abroad to promote the commercialization of various models around the world, so that advanced vaccine technology can benefit a wider range of people and create more value for shareholders and investors. "

About Rico biology.

Jiangsu Ruike Biotechnology Co., Ltd. (stock code: 02179.HK), founded in 2012, is an innovative vaccine company with independent research and development technology as the core driving force, dedicated to creating innovative vaccines covering R & D, production and commercialization. For a long time, the company has always adhered to the mission of "creating first-class vaccines to protect human health". With the powerful R & D engine composed of new adjuvants, protein engineering, immune evaluation, mRNA vaccine and other core technology platforms, the company has established more than 10 highly differentiated high-value innovative vaccine combinations, covering cervical cancer, herpes zoster, COVID-19 and other diseases with heavy burden. The core product, recombinant HPV nine-valent vaccine REC603, is currently in phase III clinical trial, and the clinical progress is leading. The new adjuvant recombinant herpes zoster vaccine REC610 has good immunogenicity, its performance is not inferior to the international mainstream Shingrix vaccine, and has entered the clinical stage. In addition, the recombinant novel coronavirus vaccine ReCOV has become one of the most competitive second-generation COVID-19 vaccines in the world, and its immunogenicity is superior to Pfizer Inc mRNA vaccine. Ruike Biology has developed a clear commercial strategy to further infiltrate the diversified vaccine market around the world. After ten years of sharpening the sword and rising abruptly based on accumulated strength, Ruike Biology is about to enter the explosive period of commercialization of its products.

Forward-looking statement

This press release may contain projections, estimates, projections, objectives, opinions, prospects, results, returns and forward-looking statements relating to the Group's financial position, results, capital position, strategy and business, which can be used in forward-looking terms. For example, "may", "will", "should", "expect", "expect", "project", "plan", "estimate", "seek", "intend", "goal", "believe", "potential" and "reasonable possibility" or their negatives or other variants or similar terms (collectively referred to as "forward-looking statements") Includes strategic priorities, R & D projects and any financial, investment and capital objectives, as well as any other goals, commitments and aspirations described in writing or orally in this presentation. Any such forward-looking statements are not reliable indicators of future performance as they may involve material statements or implied assumptions and subjective judgments that may or may not prove to be correct, accurate or complete. There is no guarantee that anything set out in the forward-looking statements is achievable, will actually occur or will be realized, or is complete or accurate. These assumptions and judgments may prove incorrect, inaccurate or incomplete and involve known and unknown risks, uncertainties, contingencies and other important factors, many of which are outside the control of the Group. There is no guarantee that the Group can successfully develop or sell its core products or other candidate products. Due to various risks, uncertainties and other factors (including, but not limited to, general market conditions, regulatory changes, geopolitical tensions or data restrictions and changes). Any such forward-looking statements are made on the basis of the Group's beliefs, expectations and opinions as at the date of the statements, and in the event of any change in circumstances or management's beliefs, expectations or opinions, the Group assumes no responsibility or obligation to update, modify or supplement these statements. For these reasons, you should not rely on any forward-looking statements and be expressly vigilant that you should not rely on any forward-looking statements. The Group or its representatives do not make any representations or warranties, express or implied, as to the realization or reasonableness of any forecasts, estimates, projections, objectives, commitments, prospects or returns contained in this presentation.

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