Financial Performance - For the six months ended June 30, 2025, the total comprehensive loss was RMB 114,065,000, a decrease of 48.0% compared to RMB 219,533,000 for the same period in 2024[2]. - The company reported a loss attributable to ordinary shareholders of RMB 112,177,000 for the six months ended June 30, 2025, compared to a loss of RMB 219,053,000 for the same period in 2024, indicating a reduction in losses by approximately 48.9%[24]. - Basic and diluted loss per share for the period was RMB 0.30, down from RMB 0.68 in the previous year, reflecting an improvement in financial performance[24]. - Total revenue for the six months ended June 30, 2024, and June 30, 2025, was RMB 0[64]. - Financial costs increased by 35.3% from RMB 5,431,000 for the six months ended June 30, 2024, to RMB 7,349,000 for the six months ended June 30, 2025[72]. Research and Development - Research and development costs were RMB 88,758,000, down 35.6% from RMB 137,758,000 in the previous year[2]. - The R&D team consists of 113 members, with approximately 56% holding master's or doctoral degrees in relevant fields[62]. - The company has established four comprehensive technology platforms for small molecule drug development, focusing on kinase biology and drug discovery[61]. - The company aims to improve pipeline feasibility and accelerate product development cycles through its advanced R&D capabilities and infrastructure[62]. - The company is developing next-generation ADCs that utilize high-activity small molecule inhibitors and PROTAC technology to improve safety and efficacy[90]. Clinical Trials and Drug Development - The core product TY-9591 has completed enrollment of 224 patients for its pivotal Phase II clinical trial, with a Pre-NDA submission expected in Q4 2025[36]. - The company is conducting a Phase III clinical trial for TY-9591 in China, with 541 patients enrolled as of July 2025, and full enrollment expected by Q2 2026[36]. - The company has initiated a Phase II clinical trial for TY-302 in breast cancer, with the trial for prostate cancer receiving ethics approval on July 10, 2025[37]. - The Phase I clinical trial for TY-2136b is ongoing in the U.S., with plans to communicate with the FDA based on collected data[38]. - TY-0540 has received regulatory approval for multiple combination therapies, with ongoing trials for breast and prostate cancer[40]. Financial Position - Non-current assets totaled RMB 311,123,000, a decrease from RMB 346,718,000 as of December 31, 2024[5]. - Current assets decreased to RMB 483,298,000 from RMB 568,975,000 in the previous year[5]. - Total liabilities decreased to RMB 259,331,000 from RMB 289,081,000 as of December 31, 2024[6]. - Net assets were reported at RMB 358,497,000, down from RMB 472,562,000 in the previous year[6]. - Cash and cash equivalents decreased to RMB 131,082,000 as of June 30, 2025, from RMB 374,988,000 at the end of 2024, a decline of approximately 65%[30]. Corporate Governance - The company has adopted a corporate governance code and has complied with all provisions except for the deviation where the roles of Chairman and CEO are held by the same person, Dr. Wu Yusheng[96]. - The board currently consists of one executive director, five non-executive directors, and four independent non-executive directors, ensuring strong independence[96]. - The company has appointed 4 vice presidents and 1 financial officer, all of whom are subject to board appointment or dismissal[112]. - The proposed amendments to the articles of association will be subject to approval by shareholders at an extraordinary general meeting[112]. Employee and Organizational Changes - As of June 30, 2025, the company has 163 employees, an increase from 144 employees as of June 30, 2024[88]. - The company plans to enhance its R&D capabilities by developing innovative drug candidates targeting CDK4, EGFR (PROTAC), and PI3Ka, among others[90]. - The commercialization team has been established with experienced members, focusing on building a systematic sales and marketing framework[94]. Funding and Investments - The government funding increased from RMB 103,205 thousand in 2024 to RMB 118,866 thousand in 2025, reflecting a growth of approximately 15.2%[34]. - The company has agreed to invest RMB 18.0 million in a newly established fund as a limited partner, in partnership with several entities including Tengyuan Changxing and Huzhou Innovation[86].
同源康医药(02410) - 2025 - 中期业绩