Taizhou, Jiangsu Province, March 21, 2024/PRNewswire/ -- On March 20, innovative vaccine company Recobiology (02179.HK) released its 2023 annual results report and latest developments. Recobiology has always adhered to the vision and mission of “creating first-class vaccines to protect human health”, guided by the company's strategy, and has achieved the following milestones and progress in research and pipeline and business operations.

Business summary

REC603-recombinant HPV nine valent vaccine

• The recombinant nine-valent HPV vaccine REC603 is undergoing phase III clinical trials in China, and regular follow-up work is being carried out according to the clinical protocol. We have completed our 24-month visit and are in the process of visiting and observing for the 30th month. We will use pathological endpoints for mid-term analysis, and submit a BLA application after the conditions are met.
• The “Technical Guidelines for Clinical Trials of Human Papillomavirus Vaccines (Trial)” issued by the Drug Evaluation Center of the State Drug Administration clearly states that “randomized, double-blind, placebo-controlled design is currently the best strategy to confirm the protective efficacy of first-generation vaccines.” Our nine-valent HPV vaccine phase III clinical plan strictly follows the guidelines of the regulatory authorities; we have the largest HPV nine-valent phase III clinical sample volume in China, and are testing in the three provinces of Henan, Shanxi and Yunnan, where HPV infection rates are high. Currently, the company is conducting visits according to the established plan to maintain clinical development progress in the first domestic production camp.
• We are actively promoting the commercialization process of the recombinant 9-valent HPV vaccine REC603 in overseas markets. In January 2024, we signed a framework agreement with Saudi Arabian pharmaceutical company SPIMACO to reconstitute the 9-valent HPV vaccine REC603 and reached authorization and strategic cooperation. Under the agreement, we exclusively authorized SPIMACO to develop, register and commercialize the recombinant 9-valent HPV vaccine REC603 in 15 Middle East and North African countries, including Saudi Arabia. Furthermore, we have successively reached cooperation agreements with partners in the UAE, the Philippines and India on the recombinant HPV nine-valent vaccine to jointly promote clinical registration and market expansion.

REC610 - New Adjuvant Recombinant Herpes Zoster Vaccine

• We have completed enrolling all participants in the Phase I clinical trial in China. Using a randomized, double-blind, parallel-controlled design, the study recruited 180 healthy subjects aged 40 and above in Pu'er City, Yunnan Province to evaluate the safety, tolerability, and immunogenicity of REC610. REC610 obtained the Drug Clinical Trial Approval Notice (Notice Number: 2023LP02151) issued by the China Drug Administration in October 2023, and was approved as a Class 3.3 biological product for prophylactic use to carry out phase I and phase III clinical trials in China.
• The Philippines' first mid-term human (FIH) clinical trial analysis yielded positive results. Previously, our REC610 conducted a FIH clinical trial in the Philippines using GlaxoSmithKline Shingrix as a positive control. Data analyzed during the study period showed that two doses of REC610 were generally safe and well tolerated in healthy subjects aged 40 and above. Rec610 can induce strong GE-specific humoral immune and cellular immune responses. Immune response occurs immediately after the first dose and peaks 30 days after the two doses. Its level is comparable to that of the Shingrix group, and is numerically higher than that of the Shingrix group.

REC625-New Adjuvant Recombinant Respiratory Syncytial Virus Vaccine

• REC625 is equipped with our self-developed novel adjuvant BFA01, which is intended to be used to prevent diseases caused by respiratory syncytial virus infection in the elderly. Preclinical studies have shown that REC625 has good immunogenicity and can induce the production of high levels of specific neutralizing antibodies. Its immunogenicity is comparable to that of mainstream international varieties.
• The project uses our self-designed vaccine antigen structure, and a relevant invention patent application has been submitted.
• We plan to complete pre-clinical research for this program in 2024.

Other matters

• The two self-developed novel adjuvants, BFA01 and BFA03, have been successfully integrated into the adjuvant supply bank managed by the Coalition for Epidemic Prevention Innovation (CEPI) with significant advantages in efficacy and safety and commercial-scale industrialization capabilities, which can meet the needs of global vaccine developers for innovative adjuvants.
• We actively promote adjuvant empowerment cooperation, work with partners to upgrade and iterate vaccines, and will share the incremental value of innovative varieties in the future. We have successively signed joint development agreements with two industry chain partners to provide them with innovative adjuvants and related technical services, and jointly develop the new adjuvant respiratory syncytial virus vaccine and the new adjuvant rabies vaccine.

Financial Summaries

Book funds

• As of December 31, 2023, the book capital was approximately RMB 912 million, compared to RMB 1,325 million as of December 31, 2022.

R&D and administrative expenses

• Compared with 2022, operating expenses (R&D and administrative expenses) in 2023 were RMB 631 million, a year-on-year decrease of about 27.55%.

Loss during the period

• The loss for the period was approximately RMB 572 million, a year-on-year decrease of 22.22%.

Dr. Liu Yong, founder, chairman of the board of directors and general manager of Recobiology, said, “Looking ahead to 2024, medium- to long-term certainty in the company's value and short-term uncertainty in the external environment are intertwined, and opportunities and challenges coexist. We firmly believe that as long as the company works hard, maintains its strategic strength, does not relax its goals, and works hard and does not slack off, it will definitely be able to hand over satisfactory answers to all shareholders. On behalf of the board of directors, I would like to sincerely thank all shareholders, partners and friends for their long-term trust and unwavering support, and also express my deep gratitude to the management and all employees who have worked with the company! We look forward to the early launch of Recobiotics products to benefit humanity, and to give back to our shareholders who have high expectations for us as soon as possible!”

About Ricoh Biotech

Jiangsu Ruike Biotechnology Co., Ltd. (hereinafter referred to as “Recobiotics” or the “Company”, Hong Kong Stock Exchange stock code: 02179) was founded in 2012 and is an innovative vaccine company with independent research and development technology as the core driving force. The company has always adhered to the mission of “creating first-class vaccines and protecting human health”. By strategically focusing on the burden of major infectious diseases, the company has built a major vaccine product pipeline portfolio with independent intellectual property rights to meet public health needs that are far from being met. After more than 20 years of technical accumulation, Recobiotics has built three innovative platforms for novel adjuvants, protein engineering, and immune evaluation. The company is one of the few companies in the world capable of developing and producing a full range of novel adjuvants. The company's three platforms work closely together to continuously develop major vaccine varieties with leading performance. Driven by a strong innovation platform, the company has built a high-value innovative vaccine pipeline portfolio with more than 10 major varieties, covering major diseases such as cervical cancer, shingles, respiratory syncytial virus, cytomegalovirus, and herpes simplex virus infections, leading the country in product development and clinical progress. After ten years of sharpening the sword and accumulating sparse resources, Recobiotics is about to enter a period of explosion in product commercialization.

Forward-looking statement

This press release may include forecasts, estimates, forecasts, objectives, opinions, prospects, results, returns, and forward-looking statements relating to the Group's financial position, operating performance, capital position, strategy and business, which may be determined by using forward-looking terms such as “may,” “will,” “should,” “anticipate,” “anticipate,” “project,” “plan,” “estimate,” “seek”, “plan,” “aim,” “believe,” “potential,” and “reasonably likely” or “reasonably likely” or denial of variation Text or similar terms (collectively, “forward-looking statements”), including strategic priorities, research and development projects and any financial, investment, and capital goals and any other goals, commitments, and ambitions described in this presentation in writing or orally. Any such forward-looking statements are not a reliable indicator of future results, as they may involve important statements or implied assumptions and subjective judgments that may or may not be proven to be correct, accurate, or complete. There is no guarantee that any of the matters set out in the forward-looking statements will be achievable, will actually occur or will be realized, or complete or accurate. These assumptions and judgments may prove incorrect, inaccurate or incomplete, and involve known and unknown risks, uncertainties, contingencies and other significant factors, many of which are beyond the control of the Group. There is also 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 limitations and changes). Any such forward-looking statement is based on the Group's beliefs, expectations and opinions as of the date the statement was made. If circumstances or management's beliefs, expectations, or opinions change, the Group does not assume and hereby disclaims any responsibility or obligation to update, modify, or supplement these statements. For these reasons, you should not rely on any forward-looking statements and be clearly cautioned that you should not rely on any forward-looking statements. The Group or its representatives make no express or implied representation or warranty as to the fulfillment or fairness of any of the predictions, estimates, projections, objectives, promises, prospects, or rewards contained in this presentation.

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