Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 20,085,000, an increase of 44.3% compared to RMB 13,923,000 in 2022[5]. - The company reported a pre-tax loss of RMB 249,350,000, a significant reduction of 65.6% from a loss of RMB 725,180,000 in 2022[5]. - Other income increased by approximately 44.3% from RMB 13.9 million in 2022 to RMB 20.1 million in 2023, primarily due to increased interest income from bank deposits[27]. - The company reported a significant reduction in other expenses, decreasing approximately 80.8% from RMB 3.1 million in 2022 to RMB 0.6 million in 2023[29]. - The net other income increased by approximately 20.3% from RMB 15.1 million in 2022 to RMB 18.2 million in 2023, mainly due to an increase in foreign exchange gains[31]. - The group's pre-tax loss decreased by approximately 65.6% to RMB 249,400,000 for the year ended December 31, 2023, compared to RMB 725,200,000 in 2022[38]. - The liquidity position improved with cash and bank balances increasing from approximately RMB 69,000,000 in 2022 to approximately RMB 265,000,000 in 2023, primarily due to net proceeds from the global offering[43]. - The group incurred listing expenses of approximately RMB 26,500,000 for the year ended December 31, 2023, an increase of approximately 22.8% from RMB 21,500,000 in 2022[37]. Research and Development - Research and development expenses rose to RMB 172,685,000, an increase of 88.9% from RMB 91,426,000 in the previous year[5]. - The company has three clinical-stage products in its pipeline, including the core product LZ901, and four preclinical-stage products[8]. - The company achieved a significant milestone in its R&D pipeline with advancements in multiple products during 2023[9]. - The company plans to actively promote the clinical development of its pipeline drugs, including LZ901, K3, and K193, and accelerate the development of other preclinical products[25]. - The company has established comprehensive internal product discovery capabilities, covering all stages of drug development from preclinical research to manufacturing[22]. - The company is focused on developing innovative human vaccines and therapeutic biological products to prevent and control infectious diseases and treat cancer and autoimmune diseases[76]. - The company is committed to research and development in the field of immunology and protein engineering[76]. - The company has initiated preclinical research for a recombinant RSV vaccine targeting lower respiratory diseases[197]. Clinical Trials and Product Development - The company completed the Phase II clinical trial of LZ901 in China in May 2023 and initiated the Phase III trial in September 2023, involving approximately 26,000 participants, with the first dose expected to be administered by December 2023[10]. - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in China in the second half of 2024, with commercialization anticipated in 2026[17]. - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, is expected to complete its Phase I clinical trial by the second quarter of 2024[18]. - The Phase II clinical trial of LZ901 showed significant immunogenicity, with the geometric mean concentration (GMC) and geometric mean titer (GMT) of the high-dose group significantly higher than the low-dose group and the placebo group[15]. - The company has decided to suspend the development of the recombinant rabies vaccine and reallocate resources to the recombinant RSV vaccine, which is currently in the preclinical stage[19]. Production and Facilities - The new production facility in Guangdong covers an area of approximately 120,000 square meters, with 72,000 square meters of production space completed, and is expected to provide an annual capacity of no less than 20 million doses of biological products[11]. - The company received the Drug Production License from the Guangdong Provincial Drug Administration in January 2023, ensuring future commercialization of human vaccines[11]. - The group reported a debt-to-asset ratio of 12.5% as of December 31, 2023, slightly up from 12.4% in 2022[44]. - The group has entered into a construction contract for a new R&D and manufacturing facility with a total construction area of approximately 45,072.87 square meters, expected to enhance its operational capacity[47]. Corporate Governance and Management - The company is led by experienced executives, including Mr. Kong Jian, who has over 35 years in the biopharmaceutical industry and has developed five commercialized vaccines[58]. - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring a balanced composition for independent judgment[136]. - The company has established mechanisms to ensure the board receives independent viewpoints, enhancing its ability to protect shareholder interests[139]. - The company has implemented effective procedures for the appointment and re-election of directors, with a term of three years[143]. - The company has established a remuneration committee to determine the remuneration policy for directors and senior management[100]. - The company has adopted a standard code of conduct for securities trading by its directors and supervisors, confirming compliance for the year ended December 31, 2023[154]. - The company emphasizes compliance with legal and regulatory policies as part of its corporate governance responsibilities[156]. Shareholder Information - The total issued share capital of the company as of December 31, 2023, is 202,449,032 shares, comprising 142,719,736 H shares and 59,729,296 non-listed shares[113]. - The company has a significant shareholder, Yitang Saiying, holding approximately 26.60% of the H shares, which equates to 37,969,696 shares[110]. - The employee incentive plan was adopted on December 15, 2021, and all rights under this plan were granted prior to the company's listing[115]. - The company has a diverse shareholder base, with multiple entities holding substantial percentages of H shares, indicating strong institutional interest[110]. - The company has confirmed that there are no other disclosures required under the Securities and Futures Ordinance regarding interests or short positions in shares or related securities[108]. Risks and Challenges - The company has faced major risks and uncertainties, which are discussed in the management discussion and analysis section of the report[78]. - The company anticipates that a majority of its future vaccine products will be sold to China's CDC, exposing it to uncertainties related to government funding and budget processes[81]. - The company may require additional financing to support its R&D and operational expansion, which it may not be able to secure[87]. - The company faces potential liability during the R&D process, particularly from product liability claims or lawsuits[80]. - The company is subject to strict regulations regarding the R&D, manufacturing, and commercialization of its products, which may impact its approval processes[85]. Environmental, Social, and Governance (ESG) - The first Environmental, Social, and Governance (ESG) report was published, detailing the company's management, practices, and performance in ESG matters[189]. - The company aims to maintain transparency and effective communication with investors through various channels, including regular reports and announcements[186]. - The company emphasizes the integration of ESG factors into its operations and decision-making processes[193]. - The company will continue to uphold gender diversity within its workforce[179].
绿竹生物-B(02480) - 2023 - 年度财报