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Innovative vaccine company Recbio (02179.HK) announced its latest progress and annual results for 2024. The company always adhered to the mission of " Protect Human Health With Best-In-Class Vaccines", and achieved the following milestones and progress in research pipeline and business operations.

 

BUSSINESS HIGHLIGHTS

REC603-Recombinant HPV 9-valent Vaccine

▪ HPV 9-valent vaccines can prevent against approximately 90% of cervical cancer and 90% of the anal and genital warts and are widely considered as the most effective vaccines for HPV. Currently, there is no domestic HPV 9-valent vaccine approved for sale in China.
▪ Our phase III clinical trial of REC603 in China is in progress and regular follow-up is being conducted in accordance with the clinical protocol. We have finished the visit and observation of the 36th month and initiated the visit and observation of the 42nd month. We will carry out an interim analysis by adopting pathological endpoints and anticipate submitting a BLA application in 2025 when conditions are satisfied.
▪ The CDE of the NMPA issued the “Technical Guidelines for the Clinical Trials of Human Papillomavirus Vaccines (for Trial Implementation)” (the “Guidelines”) in July 2023, which clearly points out that the randomized, double-blind and placebo-controlled design is still the best strategy to confirm the protective efficacy of the first-generation of vaccine for the time being. Our phase III clinical protocol for the HPV 9-valent vaccine strictly follows the guidelines of the regulatory authorities; and we have the largest HPV 9-valent vaccine 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, maintaining ranking among the leading group in China in terms of 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 vaccination is an effective means of preventing shingles. According to global research data on shingles vaccines that have been marketed, as compared to attenuated live vaccines, novel adjuvanted recombinant protein vaccines can provide stronger cellular immune and protective efficacy.
▪ At present, we have completed the enrollment and the full course of vaccination of all subjects in the phase III clinical trial in China, and are conducting follow-up visit and observation according to the clinical protocol. The randomized, double-blind and placebo-controlled clinical study is designed to evaluate the protection effectiveness, safety and immunogenicity of REC610 vaccine in healthy subjects aged 40 years and above, and a total of 24,640 subjects have been enrolled in 18 research centers in Yunnan, Henan and Shanxi provinces. Previously, exploratory clinical studies of REC610 with Shingrix® as positive control were carried out in the Philippines and China, respectively, and the expected results were obtained. The data showed that in healthy subjects aged 40 years and above, the overall safety profile of two doses of REC610 was favorable, and no vaccination-related SAEs or AESIs, or TEAEs leading to early withdrawal from the study were observed. REC610 induces strong gE-specific immune response at a level comparable to those in the Shingrix® group.

 

REC625 – Bivalent Recombinant Respiratory Syncytial Virus Vaccine
▪ The REC625 is equipped with the novel adjuvant independently developed by us and intended to prevent the diseases caused by respiratory syncytial virus infection in the elderly population. Preclinical studies have shown that REC625 has favorable immunogenicity compared to overseas marketed products and can induce high levels of specific neutralizing antibodies, and significantly improve the neutralizing antibodies against subtype B. The project adopted our independently designed vaccine antigen structure and relevant invention patent application has been submitted. We plan to complete the preclinical studies in 2025.

 

ReCOV–Recombinant Bicomponent COVID-19 Vaccine
▪ ReCOV is a recombinant COVID-19 vaccine developed by the Company comprehensively using its core technology platforms, including its novel adjuvant, protein engineering and immunological evaluation platforms, and the adjuvant used therein is its self-developed novel adjuvant BFA03. Since it obtained the first clinical trial approval in April 2021, the Company has conducted multiple clinical trials in countries including New Zealand, the Philippines, the United Arab Emirates (“UAE”), China, Russia and Nepal, achieving several complete clinical research results. ReCOV was granted the emergency use authorization in Mongolia in 2023. Currently, there is no ongoing clinical trial for this project worldwide. Given the relatively low global demand for COVID-19 vaccines at present, continuing to advance the subsequent registration and commercialization of this project may not yield favorable economic and social benefits. The Company will no longer make new rounds of clinical development for COVID-19 vaccine projects developed against the existing strains, but will reasonably allocate resources based on the future development plans for respiratory combination vaccines, the market, policy environment and other factors. As there are adjustments in the business plans for COVID-19 vaccine projects, upon in-depth analysis and prudent consideration, the Company has decided to deregister its subsidiary, Wuhan Recogen, which was established to conduct the R&D of mRNA COVID-19 vaccine. At the same time, the Company will continuously pay attention to and keep track of the mRNA vaccine technology.
▪ During the Reporting Period, the Company established a complete and systematic quality system for large-scale commercial production of vaccines at its vaccine manufacturing facility in Taizhou City, Jiangsu Province based on the COVID-19 vaccine project. The factory meets both Chinese and European Union (EU) GMP standards and has obtained a Chinese vaccine production license. It has consistently received the EU Qualified Person Declaration issued by a Qualified Person (QP) for several years. The factory has a track record of successful large-scale batch production, which is of great value in advancing the subsequent development and industrialization of the Company’s recombinant shingles vaccine REC610 and bivalent recombinant respiratory syncytial virus vaccine REC625.

 

FINANCIAL HIGHLIGHTS

Book funds

▪ The book funds were approximately RMB 457 million as of December 31, 2024, compared to RMB 912 million as of December 31, 2023.

 

R&D and administrative expenses
▪ Operating expenses (R&D and administrative expenses) in 2024 were RMB 585 million .Compared to 2023, the reduction was approximately 7.4%.

 

Loss for the year
▪ The loss for the year was approximately RMB 561 million, narrowed by 1.8% year-on-year

 

MANUFACTURING

HPV Vaccine Manufacturing Facility

Our HPV vaccine industrialisation base is built in accordance with WHO PQ standards and has entered the trial production stage, which can support the maximum annual output of 20 million doses of recombinant 9-valent HPV vaccine.

 

 

Innovation Vaccine (CHO cell) Manufacturing Facility

The factory meets both Chinese and EU GMP standards and has obtained a Chinese vaccine production license. It has consistently received the European Union (EU) Qualified Person Declaration issued by a Qualified Person (QP) for several years. The factory has a track record of successful large-scale batch production, which is of great value in advancing the subsequent development of REC610 (recombinant shingles vaccine) and REC625 (recombinant respiratory syncytial virus vaccine) of the Company.

 

 

Dr. Liu Yong, Founder, Chairman of the Board, and General Manager of Recbio, stated: "In 2024, Recbio achieved encouraging progress with parallel advancements in both R&D and industrial development. Our key product pipelines have all made progress in line with expectations. Looking ahead to 2025, Recbio is expected to submit the market authorization application for its first strategic product. This achievement embodies the collective wisdom and dedication of all Recbio employees and, more importantly, marks the imminent value return for the longstanding support from our shareholders."

 

 

About Recbio

Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (stock code: 02179.HK) is an innovative vaccine company propelled by internally developed technologies. Committed to our mission of " Protect human health with best-in-class vaccines", we have developed a comprehensive vaccine innovation engine consisting of a novel adjuvant platform, protein engineering platform and immunological evaluation platform. We are one of the few companies that are capable of independently developing and commercializing a full range of novel adjuvants. Our vaccine portfolio currently consists of more than 10 high-value innovative vaccine pipelines, covering HPV, shingles, RSV and other major diseases. Our core products recombinant HPV 9-valent vaccine REC603 and novel adjuvanted recombinant shingles vaccine REC 610, are under phase III clinical trial.

 

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.

 

Investor Inquiry:

Email: ir@recbio.cn

Tel: +86-0523-86818860

 

Media Inquiry:

Email: media@recbio.cn

Tel: +86-0523-86818860

 

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SOURCE ：Jiangsu Recbio Technology Co., Ltd.