Recbio (02179.HK) announced its latest progress and interim results for 2024. During the reporting period, we have made rapid progress in product development, achieving the following milestones and advancements in our R&D pipeline and business operations.

 

BUSSINESS HIGHLIGHTS

REC603-Recombinant HPV 9-valent Vaccine

The HPV 9-valent vaccine can prevent about 90% of cervical cancers and 90% of anal and genital warts, and is widely regarded as the most effective vaccine against HPV. At present, there is no domestically produced 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 are conducting the visit and observation of the 36th 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 “Technical Guidelines for the Clinical Trials of Human Papillomavirus Vaccines (for Trial Implementation)” (the “Guidelines”) issued by the CDE of the NMPA in July 2023 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 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.

· In January 2024, we have signed the framework agreement with SPIMACO, a pharmaceutical company in Saudi Arabia, for the recombinant HPV 9-valent vaccine REC603 and entered into a strategic cooperation. In addition, we have also signed the framework agreement with seven Commonwealth of Independent States countries including Argentina and Russia for the development, registration and commercialization of the recombinant HPV 9-valent vaccine REC603, in which the parties will separately agree on specific commercial arrangements related to REC603 under the above-mentioned framework agreement, which will be disclosed by the Company in a timely manner in accordance with the requirements of the Listing Rules.

 

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.

We have now completed the final vaccination of all subjects in phase I clinical trial in China and are conducting visits and observations according to the clinical protocol. This study adopted a randomized, double-blind, parallel controlled design in 180 healthy adult subjects aged 40 and above in Pu’er City, Yunnan Province to evaluate the safety, tolerability and immunogenicity of REC610. Data from phase I clinical trial in China indicated that the safety profile of subjects was favorable following the completion of the final vaccination. No SAE, AESI or TEAE leading to early discontinuation was reported. Based on the anticipated clinical trial results, we expect to initiate phase III clinical trial in China in 2024.

 

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 study for this project in 2024.

 

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 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 decides 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 comprehensive and systematic quality system for large-scale commercial production of vaccines based on the COVID-19 vaccine project at its vaccine production base in Taizhou City, Jiangsu Province. 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 boasts a successful track record of large-scale batch production, which is of great value for promoting 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 RMB 598 million as of June 30, 2024, compared to RMB 912 million as of December 31, 2023 .

 

R&D and administrative expenses

R&D and administrative expenses for the first half of 2024 were RMB 205 million .Compared to the first half of 2023, the reduction was approximately 17.2%.The core product REC603 is already in the 36-month follow-up stage of Phase III clinical trials, and clinical expenses have decreased compared to the previous period.

 

Administrative expenses

Administrative expenses for the first half of 2024 were RMB 55 million .Compared to the first half of 2023, the reduction was approximately 30.0%.

 

Loss during the period

The loss during the period was RMB 250 million, narrowed by 9.86% year-on-year.

 

About Recbio

Founded in 2012, Jiangsu Recbio Technology Co., Ltd. (hereafter referred to as Recbio or the Company; stock code: 2179.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 cultivated a robust portfolio of vaccine products with exclusive rights, addressing the substantial unmet needs in the realm of high-impact infectious diseases. Over the course of more than two decades, Recbio has meticulously built three pioneering platforms: a novel adjuvant platform, a protein engineering platform, and an immunological evaluation platform, making us one of the few global companies capable of both developing and manufacturing the complete range of novel adjuvants.

 

Leveraging the close integration of our three platforms, we are consistently creating promising vaccine candidates. Fueled by these innovative platforms, the Company has forged a high-value portfolio of innovative vaccines, encompassing over ten potential blockbuster varieties. These encompass areas such as cervical cancer, shingles, RSV infection, and other prevalent high-burden diseases, and have emerged as leading products in terms of development and clinical progress in China.

Having been honed and refined over the course of a decade, Recbio is poised to reap the benefits as several products are nearing commercialization.

 

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 (b0s.0662hao.com) for further details. If there is any inconsistency between this Presentation and the announcements, the announcements shall prevail.

 

 

Jiangsu Recbio Technology Co., Ltd.

 

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SOURCE ：Jiangsu Recbio Technology Co., Ltd.