Financial Performance - For the fiscal year ending December 31, 2024, the company reported total revenue of RMB 9,485,000, a decrease of 54.9% compared to RMB 21,005,000 in 2023[3]. - The company recorded a net loss of RMB 79,965,000 for the reporting period, an improvement from a net loss of RMB 132,701,000 in the previous year, representing a 39.7% reduction in losses[3]. - Other income for the year ended December 31, 2023, decreased by approximately 54.8% to about RMB 9.5 million, primarily due to a reduction in government grants received during the reporting period[33]. - The company recorded other income of approximately RMB 38.7 million during the reporting period, compared to a loss of RMB 49.6 million for the year ended December 31, 2023[34]. - The net loss decreased from approximately RMB 1,327.0 million in 2023 to approximately RMB 800.0 million in the reporting period[42]. - Basic and diluted loss per share was RMB 0.62, compared to RMB 1.43 in the previous year, showing a reduction in loss per share[68]. Research and Development - Research and development expenses increased to RMB 71,117,000, up from RMB 43,041,000, indicating a 65.2% rise in investment in R&D[3]. - R&D expenses increased from approximately RMB 430.4 million in 2023 to approximately RMB 711.7 million in the reporting period, primarily due to an increase in share-based compensation[37]. - The company is focusing on the development of antibody-cytokine fusion proteins to enhance anti-tumor effects and address challenges associated with traditional cytokine therapies[6]. - The company is leveraging its proprietary AICTM platform to enhance the design and efficacy of its antibody-cytokine fusion proteins[6]. - The company has made significant investments in innovative platforms to address technical challenges and optimize therapeutic outcomes in immunotherapy[23]. Clinical Development - The company has three core products in clinical development, including IAH0968, which is undergoing Phase II trials for biliary tract cancer, colorectal cancer, and gastric cancer[4]. - IAH0968 demonstrated a 40% objective response rate (ORR) and an 80% disease control rate (DCR) in patients with metastatic colorectal cancer and biliary tract cancer who had previously failed multiple lines of therapy[8]. - The core product IAH0968 is a 100% fucose-free anti-HER2 antibody, which aims to improve immune cell recruitment and enhance antibody-dependent cellular cytotoxicity (ADCC)[7]. - The company has completed Phase I clinical trials for IAP0971 and IAE0972, targeting late-stage solid tumors, including non-small cell lung cancer and colorectal cancer[4]. - IAH0968 has completed Phase I clinical trials for late-stage HER2+ malignancies, with IND approval obtained in September 2022 for Phase II and III trials[9]. - IAP0971 demonstrated good safety at doses up to 200µg/kg in Phase I trials, with initial anti-tumor activity observed in five patients[11]. - IAE0972 has completed Phase I trials with 14 patients enrolled, showing initial efficacy and no dose-limiting toxicities[14]. - IND approvals for IAP0971 and IAE0972 were obtained from both the National Medical Products Administration and the FDA for late-stage malignancies[12][14]. - IAE0972 is set to enter Phase II and III trials for recurrent or metastatic head and neck squamous cell carcinoma and nasopharyngeal carcinoma in September 2024[15]. - The company has achieved significant milestones in clinical trial completions and IND approvals over the past two years[10][12]. Product Pipeline - The product pipeline includes multiple candidates across various stages, with IAH0968, IAN0982, IAE0972, IBC0966, IBD0333, ISH0888, ISH0613, IAP0971, and IBB0979 listed as core candidates[19]. - The company is developing ISH0613 as a monotherapy for systemic lupus erythematosus (SLE) and IAN0982 for late-stage solid tumors, either as a monotherapy or in combination with other therapies[18]. - IBB0979 is a dual-function antibody-IL-10 fusion protein currently in clinical trials, with FDA and National Medical Products Administration approvals for Phase I and II trials for late-stage or metastatic solid tumor patients obtained in October and November 2022, respectively[17]. - IBC0966, a PD-L1-SIRPα dual-function fusion protein, has completed Phase I clinical trials as a monotherapy for advanced malignancies by December 2023, with exclusive rights for development and commercialization in Greater China obtained from Yimingang Biotechnology[17]. - IBD0333, a 4-1BB and CD24 bispecific antibody, received IND approvals from the FDA and National Medical Products Administration in June and July 2023, respectively, and Phase I clinical studies targeting late-stage/metastatic solid tumor patients are set to begin in March 2024[17]. Financial Position - Cash and cash equivalents totaled approximately RMB 790.0 million as of December 31, 2024, a decrease of approximately 36.9% from RMB 1,251.0 million as of December 31, 2023[43]. - Current assets amounted to approximately RMB 4,930.0 million, while current liabilities were approximately RMB 441.0 million, including interest-bearing bank loans of approximately RMB 343.0 million[44]. - Total liabilities, including interest-bearing bank loans and lease liabilities, were approximately RMB 41,196.0 million as of December 31, 2024, compared to RMB 320,599.0 million in 2023[46]. - The debt-to-asset ratio decreased to approximately 8.7% as of December 31, 2024, compared to approximately 135.8% as of December 31, 2023[48]. - The group's capital commitments amounted to RMB 23.3 million as of December 31, 2024, primarily related to contracts with suppliers for equipment purchases and land use rights[51]. Governance and Compliance - The audit committee has reviewed the consolidated financial statements and annual performance without any objections[64]. - The company has adopted corporate governance principles and will comply with all applicable rules until December 31, 2024[60]. - The company has established an audit committee consisting of three independent non-executive directors[63]. - The group is committed to complying with the applicable disclosure requirements set by the Hong Kong Stock Exchange and the Companies Ordinance[79]. Future Plans - The company plans to expand its GMP-compliant production facilities to enhance production capacity and begin building its commercial team[31]. - The company aims to focus on the development of antibody cytokines to strengthen its position in the drug development field[31]. - The company plans to actively seek international collaboration opportunities to maximize asset value and enhance global brand recognition[31]. - The company plans to list on May 24, 2024, under stock code 2898[119].
盛禾生物(02898) - 2024 - 年度业绩