Research and Development Achievements - In 2023, Jiangsu Recbio Technology achieved multiple milestone achievements in the research and development and commercialization of various vaccine pipelines[7]. - Early investments in research and development have started to yield satisfactory outcomes despite a challenging environment[7]. - The company has developed a comprehensive vaccine innovation engine with novel adjuvant and protein engineering platforms[20]. - The company is focused on expanding its vaccine portfolio to address various viral infections, including HPV, RSV, and COVID-19[34]. - The company is committed to advancing its research initiatives in the field of immunology and vaccine development[162]. - The company reported a significant increase in R&D activities, focusing on novel vaccine development, with over 60 publications and 20 invention patents since 1998[141]. - The in-house R&D team consists of over 100 personnel, most holding advanced degrees in relevant fields, supporting the full-cycle vaccine R&D[78]. - The company has developed three advanced technology platforms for novel adjuvant development, protein engineering, and immunological evaluation, enhancing its ability to discover and develop subunit vaccines[73]. Clinical Trials and Vaccine Development - The phase III clinical trial of the recombinant HPV 9-valent vaccine REC603 in China has reached its 30th month, advancing towards new drug application[8]. - The company has successfully enrolled all subjects for the phase I clinical trial of the novel adjuvanted recombinant shingles viral vaccine REC610 in China, with promising results from the first-in-human trial in the Philippines[8]. - The clinical trial for REC603 commenced in March 2019 and was completed in July 2020, demonstrating the company's commitment to advancing its vaccine pipeline[35]. - The phase III clinical trial for REC603 in China involves 16,050 subjects and includes primary efficacy, immuno-bridging, and immunogenicity comparative trials with Gardasil®9[37]. - REC610 received drug clinical trial approval from the NMPA in October 2023 for phase I and phase III clinical trials in China[31]. - The adverse event rate for REC603 was 53.75%, significantly lower than the 86.6% rate reported for Gardasil®9 in a 2009 trial[41]. - The company aims to ensure smooth transition of vaccine candidates into successful commercial products through early-stage manufacturing capabilities[22]. Financial Performance - The company reported a loss before tax of RMB 572,443,000 for the year ended December 31, 2023, an improvement from a loss of RMB 735,996,000 in 2022[17]. - The loss attributable to owners of the parent for 2023 was RMB 571,957,000, compared to RMB 722,703,000 in 2022[17]. - The basic and diluted loss per share for 2023 was RMB 1.19, compared to RMB 1.52 in 2022[17]. - Total non-current assets increased to RMB 1,056,904, up 18.8% from RMB 889,687 in 2022[18]. - Total current assets decreased to RMB 1,129,373, down 20.4% from RMB 1,419,920 in 2022[18]. - Other income and gains decreased by 32.0% from RMB 148.0 million in 2022 to RMB 100.6 million in 2023, primarily due to a RMB 97.6 million decrease in exchange gains[107]. - Research and development costs decreased by 31.9% from RMB 716.4 million in 2022 to RMB 487.8 million in 2023, indicating a significant reduction in R&D expenditure[111]. Manufacturing and Production Capacity - The HPV vaccine industrialization base has a designed production capacity of 20 million doses per year, compliant with WHO pre-qualification standards[10]. - The innovative vaccines manufacturing facility has a total GFA of approximately 17,000 sq.m. and meets EU GMP standards[22]. - The manufacturing facility received the European Union Qualified Person Declaration in April 2022, indicating compliance with EU GMP standards[22]. - The company is constructing an HPV vaccine manufacturing facility in Taizhou, Jiangsu province, with a designed peak annual capacity of 20 million doses of HPV 9-valent vaccines[91]. - The production base for innovative vaccines has acquired a manufacturing license and produced multiple batches of the novel adjuvanted recombinant shingles viral vaccine[10]. Market Expansion and Commercialization - The company has made substantial progress in overseas market commercialization, reaching intention agreements for clinical registration and market expansion in regions including the Middle East and Southeast Asia[12]. - The company has signed joint development agreements with two industry chain partners for new adjuvant respiratory syncytial virus vaccines and new adjuvant rabies vaccines[8]. - A framework agreement was signed with SPIMACO for the recombinant HPV 9-valent vaccine REC603, allowing exclusive development and commercialization in 15 Middle East and North Africa countries[94]. - The company aims to adopt reasonable follow-up development strategies based on market demand and regulatory guidance for its products[33]. - The company plans to submit a Biologics License Application (BLA) to the NMPA in 2025, contingent on interim analysis results[37]. Governance and Management - The company is committed to corporate governance and investor relations, ensuring transparency and accountability[156]. - The management team emphasizes collaboration with academic institutions to foster innovation and research advancements[146]. - The leadership team includes professionals with degrees from prestigious institutions, enhancing the company's governance and operational effectiveness[159]. - The company has a diverse board with expertise in law, finance, and medical research, enhancing its strategic decision-making capabilities[177]. - The management team is committed to enhancing operational efficiency and strategic development to drive growth[146]. Awards and Recognition - The company has been recognized with a "Gelonghui Golden Award" for being an excellent public health enterprise and as the "Most Popular New Stock" among new listings[14]. - Dr. Liu has been awarded as one of the "Top Ten Innovative and Entrepreneurial High-level Talents" in 2020[145].
瑞科生物(02179) - 2023 - 年度财报