Financial Performance - Total comprehensive loss for the year ended December 31, 2024, was RMB 387,928 thousand, a slight increase of 1.2% compared to RMB 383,171 thousand in 2023[3]. - Revenue for the year was RMB 107 thousand, with a gross profit of RMB 14 thousand, indicating minimal sales activity[5]. - The company reported a basic and diluted loss per share of RMB 1.15, compared to RMB 1.32 in the previous year, indicating a slight improvement in loss per share[5]. - The pre-tax loss for 2024 is RMB (387,928,000), slightly higher than the pre-tax loss of RMB (383,171,000) in 2023, indicating a marginal increase in losses[29]. - The company's loss increased by 1.2% from RMB 383,171,000 for the year ended December 31, 2023, to RMB 387,928,000 for the year ended December 31, 2024[82]. Expenses and Costs - Research and development costs decreased by 5.5% to RMB 235,446 thousand from RMB 249,252 thousand in the previous year[3]. - Administrative expenses surged by 82.7% to RMB 108,332 thousand, up from RMB 59,306 thousand in 2023[3]. - Total financial costs decreased to RMB 12,817,000 in 2024 from RMB 22,236,000 in 2023, a reduction of approximately 42.3%[26]. - Employee costs, including director remuneration, totaled RMB 72,778,000 in 2024, compared to RMB 70,831,000 in 2023, reflecting a slight increase of about 2.8%[22]. - The depreciation of property, plant, and equipment increased to RMB 9,272,000 in 2024 from RMB 7,798,000 in 2023, an increase of about 18.9%[22]. Assets and Liquidity - Cash and bank balances increased significantly to RMB 460,463 thousand from RMB 186,830 thousand in 2023, reflecting improved liquidity[6]. - Current net assets improved to RMB 279,894 thousand from a deficit of RMB 1,067,270 thousand in the previous year[7]. - Total assets less current liabilities stood at RMB 626,612 thousand, a recovery from a negative position of RMB 727,841 thousand in 2023[7]. - Non-current total assets increased to RMB 346,718 thousand from RMB 339,429 thousand in 2023, showing stability in long-term asset management[6]. - Cash and cash equivalents increased to RMB 374,988,000 in 2024 from RMB 186,830,000 in 2023, with RMB 280,912,000 held in HKD and RMB 90,597,000 in RMB[39]. Research and Development - The company is primarily engaged in the research, development, and commercialization of pharmaceutical products, with a focus on drug discovery[8]. - Revenue from research and development services for 2024 is RMB 107,000, compared to RMB 0 in 2023[18]. - The company expects to recognize revenue from research and development services over the service period, indicating a focus on long-term projects[19]. - The company has a R&D team of 110 members as of December 31, 2024, with approximately 57% holding master's or doctoral degrees in relevant fields[69]. - The company is focusing on the development of its proprietary drug design and screening platform, which has led to the identification and synthesis of multiple drug candidates[68]. Clinical Trials and Product Development - The company has initiated a key Phase II clinical trial for its core product TY-9591, with 224 patients enrolled as of November 2024, and plans to submit a Pre-NDA application in April 2025[43]. - The company is conducting a Phase II clinical trial for TY-302 in breast cancer, with plans to enter the registration phase by 2026, and will initiate a Phase II trial for prostate cancer in the first half of 2025[44]. - The company has received IND approval for TY-2136b and is currently conducting a Phase I clinical trial in the U.S., with plans to communicate with the FDA regarding future development[45]. - TY-0540 is in Phase I clinical trials in China for advanced solid tumors, with an expansion cohort study for breast and ovarian cancer initiated in February 2025[47]. - The company has established a pipeline of 12 candidate drugs since its inception in 2017, including core product TY-9591, which is undergoing critical Phase II and III trials in China for lung cancer[52]. Market and Commercialization - The company successfully listed on the Hong Kong Stock Exchange on August 20, 2024, raising approximately HKD 579.3 million from the issuance of 47,880,000 H shares at HKD 12.10 per share[51]. - The company is actively expanding its commercialization team to enhance brand promotion and market potential through various academic and industry collaborations[70]. - The company plans to actively explore commercial collaboration opportunities with leading industry peers to accelerate the development of its candidate drugs and enhance their clinical and commercial value in key international markets[97]. - The company has established a commercialization team with experienced core management to meet its commercialization needs and will continue to integrate capital, talent, and technology advantages[97]. Governance and Compliance - The company has complied with all provisions of the corporate governance code since its listing, except for the deviation regarding the roles of the Chairman and President being held by the same person[99]. - The audit committee is composed of two independent non-executive directors and one non-executive director, ensuring a strong independence in its composition[106]. - The audit committee's responsibilities include overseeing the financial reporting system, risk management, and internal control systems[107]. - The company will continue to regularly review and monitor its corporate governance practices to ensure compliance with the corporate governance code[100]. Future Outlook - The company aims to enter the registrational clinical stage for several products by 2026, including TY-302 for prostate cancer and TY-2699a for breast and pancreatic cancers[53]. - The company plans to enhance its R&D capabilities and has developed several innovative drug candidates targeting YAP-TEAD, CDK4, and EGFR (PROTAC)[94]. - The company is developing next-generation ADCs utilizing high-activity small molecule inhibitors and PROTAC technology to improve safety and efficacy in cancer treatment[94][95]. - The company aims to leverage AI models in drug discovery to enhance R&D efficiency and drive sustainable growth[96].
同源康医药-B(02410) - 2024 - 年度业绩