Jiangsu Recbio Technology Co., Ltd. announced 2023 annual results report and latest progress
BUSSINESS HIGHLIGHTS
REC603-Recombinant HPV 9-valent Vaccine
- We are in the process of conducting phase III clinical trial of REC603 in
China and follow-up is being conducted in accordance with the clinical protocol. We have completed the 24th month follow-up visit and are conducting the 30th month follow-up visit observation. We plan to take the pathological endpoint for interim analysis and submit BLA application after meeting the conditions. - 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; and we have the largest HPV 9-valent phase III clinical trial subjects inChina and are conducting clinical trials inHenan ,Shanxi andYunnan 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 inChina in term of the clinical development progress. - We are actively promoting the commercialization of recombinant HPV 9-valent vaccine REC603 in overseas markets. In
January 2024 , we have signed the framework agreement with SPIMACO, a pharmaceutical company inSaudi Arabia , for the recombinant HPV 9-valent vaccine REC603 and entered into an authorization and strategic cooperation. According to the agreement, we exclusively license SPIMACO to develop, register and commercialize recombinant HPV 9-valent vaccine REC603, in 15 Middle East andNorth Africa countries, includingSaudi Arabia . In addition, we have successively achieved intention of cooperation with partners in theUnited Arab Emirates ,the Philippines andIndia on the recombinant HPV 9-valent vaccine to jointly promote clinical registration and market expansion.
REC610 – Novel Adjuvanted Recombinant Shingles Vaccine
- We have completed enrollment of all subjects in the phase I clinical trial in
China . The study proposes to adopt a randomized, double-blind, parallel controlled design for enrolled 180 healthy adult subjects aged 40 and above in Pu'er,Yunnan Province to evaluate the safety, tolerability and immunogenicity of REC610. REC610 has obtained the Notice on Drug Clinical Trial Approval (notice number: 2023LP02151) issued by the NMPA inOctober 2023 , which is authorized to carry out phase I and phase III clinical trials inChina as a Category 3.3 biological product for preventive use. - Positive results from the first-in-human ("FIH") clinical trial interim analysis in
the Philippines . Previously, the Company's REC610 commenced the FIH clinical trial with GSK Shingrix® active controlled inthe Philippines . The Interim Analysis (IA) results showed that REC610 demonstrated overall favorable safety and tolerability profile in healthy participants aged 40 and above after two doses of the vaccination. REC610 induced strong gE-specific humoral and cellular immune responses, which were evident after the first vaccination and reached the peak at 30 days after the second vaccination. The humoral and cellular immune responses were comparable between REC610 and Shingrix® group, and the immune response level in REC610 group was numerically higher than that in Shingrix® group.
REC625–Novel Adjuvanted Recombinant Respiratory Syncytial Virus Vaccine
- The REC625 is equipped with the novel adjuvant BFA01 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 and can induce high levels of specific neutralizing antibodies, and its immunogenicity is comparable to that of international mainstream varieties.
- The project adopted our independently designed vaccine antigen structure and relevant invention patents application has been submitted.
- We plan to complete the preclinical studies of this project in 2024.
Others
- The two independently developed novel adjuvants, BFA01 and BFA03, have been successfully included in the adjuvant supply pool managed by the
Coalition for Epidemic Preparedness Innovations ("CEPI") due to their significant advantages in efficacy and safety, as well as their commercial-scale industrialization capabilities, to meet the demand for innovative adjuvants from vaccine developers around the world. - We actively promote the cooperation of adjuvant empowerment and work with partners to achieve the upgrade and iteration of 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 innovative adjuvants and related technical services to jointly develop novel adjuvant respiratory syncytial virus vaccine and novel adjuvant rabies vaccine.
FINANCIAL HIGHLIGHTS
Cash and bank balances
- Cash and cash equivalents were approximately
RMB 912 million as ofDecember 31, 2023 , compared toRMB 1.325 billion as ofDecember 31, 2022 .
R&D and administrative expenses
- Operating expenses (R&D and administrative expenses) in 2023 were RMB 631 million .Compared to 2022, the reduction was approximately 27.55%.
Loss for the year
- The loss for the year was approximately
RMB 572 million , narrowed by 22.22% year-on-year
About Recbio
Founded in 2012,
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
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
Investor Inquiry:
Email: ir@recbio.cn
Tel: +86-0523-86818860
Media Inquiry:
Email: media@recbio.cn
Tel: +86-0523-86818860
Related Links:
https://www.recbio.cn/
View original content:https://www.prnewswire.com/news-releases/jiangsu-recbio-technology-co-ltd-announced-2023-annual-results-report-and-latest-progress-302094826.html
SOURCE