Clinical Trials and Vaccine Development - The company is conducting a Phase III clinical trial for REC603, a recombinant nine-valent HPV vaccine, with a total sample size of 16,050 participants, and expects to submit a BLA application by 2025[1]. - REC610, a new adjuvanted recombinant shingles vaccine, has received clinical trial approval in the Philippines, with the first participant enrolled on February 13, 2023[3]. - The ReCOV vaccine demonstrated superior neutralizing antibody levels against the original strain and Omicron variants compared to Pfizer's mRNA vaccine in a Phase II trial conducted in the Philippines[4]. - The company plans to submit a clinical trial application for the next-generation nine-valent HPV vaccine, REC604b, in 2023[8]. - The company is advancing early research on REC606, a recombinant vaccine for adult tuberculosis, utilizing protein engineering and new adjuvant technology[9]. - The company has obtained exclusive global development rights for REC607, a viral vector candidate vaccine for adult tuberculosis, and is currently conducting preclinical research[10]. - The ongoing Phase III clinical trial in China has a total sample size of 16,050 participants, with significant progress made in immunogenicity bridging studies and comparisons with Gardasil®9[40]. - The company is developing the recombinant human tuberculosis vaccine (REC606) using protein engineering and novel adjuvant technology platforms, aiming for improved safety and immune response[52]. - The early-stage recombinant quadrivalent influenza vaccine (REC617) is under development, focusing on enhancing tolerability, immunogenicity, and cross-protection capabilities[52]. - The company is working on a multivalent hand-foot-mouth disease vaccine (REC605) with higher coverage rates for EV71, CA16, CA10, and CA6 serotypes[53]. Financial Performance - Total other income and gains for 2022 reached RMB 147,993 thousand, a significant increase from RMB 27,810 thousand in 2021, representing a growth of 432%[13]. - The company reported a pre-tax loss of RMB (735,996) thousand for 2022, compared to a loss of RMB (657,566) thousand in 2021, indicating an increase in losses of approximately 12%[15]. - Basic and diluted loss per share for the year was RMB (1.52), slightly improved from RMB (1.56) in 2021[15]. - Total non-current assets increased to RMB 889,687 thousand in 2022, up from RMB 624,649 thousand in 2021, reflecting a growth of 42.5%[14]. - Current assets totaled RMB 1,419,920 thousand in 2022, compared to RMB 1,294,571 thousand in 2021, marking an increase of 9.7%[14]. - Current liabilities rose to RMB 328,983 thousand in 2022, up from RMB 139,293 thousand in 2021, representing an increase of 136%[14]. - The net assets of the company stood at RMB 1,653,078 thousand as of December 31, 2022, a slight decrease from RMB 1,673,296 thousand in 2021[16]. - Research and development expenses for 2022 were RMB (716,444) thousand, significantly higher than RMB (472,953) thousand in 2021, indicating an increase of 51.5%[15]. - The company reported a loss before tax of RMB (735,996,000) for the year ended December 31, 2022, compared to a loss of RMB (657,566,000) for the year ended December 31, 2021, reflecting an increase in losses of approximately 11.9%[26]. - The company incurred a loss on the sale of property, plant, and equipment amounting to RMB 55,000 for the year ended December 31, 2022, compared to RMB 19,000 in the previous year[23]. Vaccine Pipeline and Production Capacity - The peak production capacity of the HPV vaccine industrialization base will be increased to 20 million doses per year to meet the growing market demand in China and internationally[2]. - The company has developed a portfolio of 12 vaccine candidates, including three strategic products: REC603 (a recombinant HPV nine-valent vaccine in Phase III clinical trials), ReCOV (a recombinant bivalent COVID-19 vaccine in the product registration phase), and REC610 (a new adjuvant recombinant shingles vaccine in clinical research)[35]. - The production capacity for the HPV nine-valent vaccine at the new facility in Taizhou, Jiangsu Province is designed to be 20 million doses per year[35]. - The Taizhou production facility has a total construction area of approximately 17,000 square meters and has received production licenses from the Jiangsu Provincial Drug Administration and compliance statements from the EU quality authorization person[35]. - The company has established a scalable production capability for HPV virus-like particles, ensuring stable high yields for both domestic and global market demands[41]. Research and Development Initiatives - The company is developing new adjuvants for its candidate vaccines to enhance tolerability and immunogenicity[11]. - The company has established an integrated vaccine innovation engine, including novel adjuvant platforms, protein engineering platforms, and immune evaluation platforms[35]. - The company has established three advanced technology platforms for adjuvant development, protein engineering, and immunoassay, facilitating the discovery and development of subunit vaccines[54]. - The company has a dedicated internal production team that manufactures most of the candidate vaccines used in clinical trials, including the HPV vaccine pipeline[58]. - The company is committed to enhancing patient tolerance to drugs, which is a critical aspect of their clinical research[106]. Market and Competitive Position - The potential market demand for HPV vaccines in China is substantial, with an estimated 701.7 million doses needed by 2025 due to a significant number of unvaccinated women aged 9 to 45[41]. - The company holds a competitive advantage with its cost-effective domestic HPV vaccines, which captured 66.7% of the HPV bivalent vaccine market in its first year[42]. - The existing HPV vaccines in China have an age range of 9 to 45 years, which aligns with the target demographic for REC603[42]. - The company is positioned to benefit from favorable government policies aimed at accelerating the approval and adoption of domestic HPV vaccines[42]. Corporate Governance and Future Plans - The company has confirmed compliance with corporate governance codes and maintains high standards to protect shareholder interests[92]. - The board believes that having the same individual serve as both chairman and CEO will not affect the balance of power and responsibilities within the board[92]. - The company plans to utilize the net proceeds from the global offering by the end of 2023, with a total of RMB 669.714 million allocated for various purposes[95]. - The company will continuously review the usage plan of unutilized net proceeds to adapt to changing market conditions[96]. - The company is exploring strategic acquisitions to enhance its product offerings and market reach[103].
瑞科生物-B(02179) - 2022 - 年度业绩