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].

Product Development - Sunho Biologics reported three core products: IAH0968, IAP0971, and IAE0972, with IAH0968 currently in Phase II clinical trials for cholangiocarcinoma and colorectal cancer[6]. - IAP0971 and IAE0972 have completed Phase I clinical trials targeting advanced solid tumors, including non-small cell lung cancer and colorectal cancer[6]. - The company is developing antibody-cytokine fusion proteins to enhance anti-tumor effects, addressing limitations of traditional cytokine therapies[7]. - IAH0968 is designed to target the human epidermal growth factor receptor 2 (HER2) with enhanced binding affinity, significantly improving its therapeutic potential[7]. - The company aims to expand its research capabilities to include bispecific antibodies and fusion proteins for broader therapeutic applications beyond oncology[7]. - Sunho Biologics is focused on overcoming challenges such as short half-lives and systemic toxicity associated with conventional cytokine drugs[7]. - The company has established a proprietary platform (GAIC™) to strengthen its antibody-cytokine fusion protein development[7]. - Future product development is expected to address the needs of cancer patients facing immune suppression and drug resistance[7]. - Core product IAH0968 is a 100% fucose-free anti-HER2 antibody, showing an objective response rate (ORR) of 40% and a disease control rate (DCR) of 80% in patients with metastatic CRC and BTC who failed multiple prior therapies[9]. - IAH0968's Phase I clinical trial demonstrated good tolerability with only one dose-limiting toxicity (DLT) observed at a dosage of 10 mg/kg, with no maximum tolerated dose (MTD) reached[9]. - IAP0971, a dual-target PD-1 antibody, showed good safety at a high dose of 200 μg/kg in its Phase I trial, with no DLT or MTD observed[12]. - Initial anti-tumor efficacy was observed in four patients with advanced malignancies treated with IAP0971, all achieving stable disease (SD) after two cycles[12]. - The company plans to initiate Phase II clinical trials for IAP0971 in China in Q3 2024[12]. - IAE0972, a dual-target EGFR antibody, completed a Phase I trial with 14 patients, observing only one grade 3 adverse event and no DLT or MTD[14]. - Preliminary efficacy was noted in patients with advanced solid tumors treated with IAE0972, with some achieving stable disease after two treatment cycles[14]. - The company is advancing multiple clinical trials for its products, with expectations to complete Phase IIb trials for CRC by Q4 2024 and Phase II trials for BTC by Q3 2025[10][12]. - The focus on fucose removal in antibody design aims to enhance ADCC activity, a strategy widely attempted in the biopharmaceutical industry[9]. - IBC0966, a clinical-stage anti-PD-L1 antibody, completed Phase I trials for advanced malignancies in December 2023 and is expected to enter Phase III trials in Q2 2025[17]. - IBB0979, a dual-functional antibody, is currently in Phase I trials, with completion expected in Q4 2024[15]. - IBD0333, a bispecific antibody, received IND approval in June and July 2023, with Phase I trials starting in March 2024 and completion anticipated in Q3 2025[17]. - IAN0982, developed on the AIM™ platform, is expected to submit IND applications to regulatory authorities in Q2 2025[18]. - ISH0613, targeting systemic lupus erythematosus, is projected to submit IND applications in Q4 2024[18]. - The company is developing multiple candidates in clinical and IND application stages, indicating a robust pipeline with high commercial viability[15]. - The product pipeline includes a mix of therapies targeting both innate and adaptive immunity, showcasing the company's strategic focus on immuno-oncology[17]. Financial Performance - Other income decreased by approximately 70.4% from about RMB 6.0 million in the first half of 2023 to approximately RMB 1.8 million in the reporting period, primarily due to a reduction in government subsidies[35]. - Research and development expenses increased from approximately RMB 24.6 million in the first half of 2023 to about RMB 37.7 million in the reporting period, mainly due to an increase in share-based compensation for R&D personnel[40]. - The company recorded listing expenses of approximately RMB 23.0 million during the reporting period, compared to about RMB 9.6 million in the previous period[44]. - The company's net loss decreased from approximately RMB 61.5 million for the six months ended June 30, 2023, to about RMB 36.0 million in the reporting period[46]. - The company reported a loss before tax of RMB 36,077,000, improving from a loss of RMB 61,489,000 in the same period last year, indicating a reduction in losses by approximately 41.3%[85]. - Basic and diluted loss per share improved to RMB 0.34 from RMB 0.67, reflecting a decrease in loss per share by approximately 49.3%[85]. - The company did not recommend the payment of an interim dividend for the period ended June 30, 2024[83]. - The company reported a total of RMB 38,720,000 in other income and losses, significantly higher than RMB 15,000 in the prior year[108]. - The company incurred total expenses of RMB 28,463,000 during the period, a decrease of 24% from RMB 37,572,000 in the previous year[114]. - The company recognized a gain of RMB 34,782,000 from the fair value changes of financial liabilities, which was not present in the previous year[108]. - For the six months ended June 30, 2024, the company reported a net loss attributable to shareholders of RMB 36,077,000, compared to a net loss of RMB 61,489,000 for the same period in 2023, representing a 41.3% improvement in losses[118]. Capital and Assets - As of June 30, 2024, the total cash and cash equivalents amounted to approximately RMB 493.9 million, an increase of about 294.9% compared to RMB 125.1 million as of December 31, 2023[47]. - The current assets were approximately RMB 514.5 million, while current liabilities were approximately RMB 34.8 million, including interest-bearing bank loans of RMB 23.0 million[47]. - The debt-to-asset ratio decreased to approximately 6.7% as of June 30, 2024, down from approximately 135.8% as of December 31, 2023[50]. - As of June 30, 2024, the company had capital commitments of RMB 25.5 million, primarily related to contracts for equipment purchases and land use rights[52]. - Non-current assets totaled RMB 72,919,000 as of June 30, 2024, compared to RMB 63,309,000 at the end of 2023, showing an increase of about 15.5%[87]. - The company’s total equity attributable to owners increased to RMB 548,023 thousand as of June 30, 2024, from RMB (104,109) thousand at the beginning of the year[93]. - The company’s total liabilities decreased to RMB 9,568,000 as of June 30, 2024, from RMB 73,960,000 at the end of 2023[122]. Shareholder Information - As of June 30, 2024, the total issued shares of the company were 156,666,800[71]. - Sunho Wisdom holds 88,000,000 shares, representing 56.17% of the company's total issued shares[69]. - Zhang Feng holds 100,000,000 shares, accounting for 63.83% of the total issued shares[69]. - The major shareholder, 恒泰信託(香港)有限公司, holds 94,000,000 shares, which is 60.00% of the total issued shares[69]. - 湖州市倚锋安盛创投合伙企业 holds 11,666,660 shares, representing 7.45% of the total issued shares[69]. - 深圳市倚锋控股集团有限公司 holds 17,500,000 shares, accounting for 11.17% of the total issued shares[69]. - The company has adopted a Restricted Share Unit Plan as of August 2, 2023, allowing for a maximum of 6,000,000 shares to be issued under the plan[72]. - As of June 30, 2024, no other individuals hold any recorded interests in the company's shares[68]. Research and Development - The company emphasizes the importance of R&D investment for long-term growth and product pipeline diversification through both internal development and external collaborations[30]. - The AIC™ platform enables high expression levels of up to 4g/L and 86% purity in antibody production[27]. - The company aims to activate immune cells through innovative therapies targeting various cancers, including glioblastoma and prostate cancer[17]. - The company plans to apply for IND approval for combination therapy clinical trials based on data collected from single-agent trials[23]. - The platforms are designed to address technical challenges and resistance issues in immunotherapy development[24]. - The integrated biotherapeutic platform covers all key functions of biopharmaceutical development, enhancing pipeline feasibility and reducing development costs[30]. Production Capacity - The company established a production capacity of 1,600 liters with four active production lines, including three 200-liter and one 1,000-liter single-use bioreactors[33]. - The company completed the installation of a 5,000-liter bioreactor production line, which received qualification certification in November 2023, enabling the production of candidates for Phase III clinical trials and commercialization[33]. - The company has successfully produced over 30 batches of antibodies, meeting the needs for preclinical research and early clinical trials[33]. Corporate Governance - The company has established an audit committee consisting of three independent non-executive directors, ensuring compliance with corporate governance standards[81]. - The company has no changes in the board of directors since its listing date[65].

Financial Performance - Total other income decreased to RMB 1,782,000 from RMB 6,024,000, representing a decline of approximately 70.4% year-over-year [3]. - Net other gains and losses increased significantly to RMB 38,720,000 compared to RMB 15,000 in the previous year [4]. - Research and development expenses rose to RMB (37,708,000), up from RMB (24,610,000), indicating a 53.2% increase [3]. - Administrative expenses decreased to RMB (15,270,000) from RMB (33,130,000), a reduction of approximately 53.8% [3]. - The company reported a net loss of RMB (36,077,000) for the period, an improvement from a loss of RMB (61,489,000) in the same period last year, reflecting a 41.3% reduction in losses [4]. - Cash and cash equivalents increased significantly to RMB 493,882,000 from RMB 125,074,000, marking a growth of 294.5% [5]. - Total assets net of current liabilities improved to RMB 552,627,000 from a negative RMB (97,213,000) in the previous year [6]. - The company’s basic and diluted loss per share improved to RMB (0.34) from RMB (0.67) year-over-year [4]. - The company’s total liabilities decreased significantly, with trade and other payables dropping to RMB 9,568,000 from RMB 73,960,000 [5]. - The company reported a loss attributable to shareholders of RMB 36,077 thousand for the six months ended June 30, 2024, compared to a loss of RMB 61,489 thousand for the same period in 2023, indicating a reduction in losses [15]. Product Development - The company has three core products under development: IAH0968, IAP0971, and IAE0972, all of which are self-developed monoclonal antibodies and cytokines targeting cancer and autoimmune diseases [17]. - IAH0968 has initiated Phase II clinical trials for cholangiocarcinoma and colorectal cancer, while IAP0971 and IAE0972 have completed Phase I clinical trials for late-stage solid tumors, including non-small cell lung cancer and colorectal cancer [17]. - The core product IAH0968 is a 100% glycoengineered anti-HER2 antibody, showing a 40% objective response rate (ORR) and an 80% disease control rate (DCR) in patients with metastatic CRC and BTC who have failed multiple prior therapies [20]. - IAH0968 has demonstrated good tolerability and anti-tumor activity in patients with advanced HER2+ malignancies, with only one dose-limiting toxicity (DLT) reported at a dosage of 10 mg/kg [21]. - The core product IAP0971 is a dual-target antibody designed to activate immune cells, including CD8+ T cells and NK cells, by blocking the PD-1/PD-L1 signaling pathway [22]. - IAP0971 completed Phase I clinical trial in July 2023, showing good safety at 200μg/kg with no dose-limiting toxicities (DLT) or maximum tolerated dose (MTD) observed [23]. - IAE0972, a dual-target antibody, completed dose escalation in Phase I trials with only one grade 3 adverse event reported, and no DLT or MTD reached [25]. - IBB0979, another antibody-cytokine fusion protein, is currently in Phase I trials, with the first patient dosed in July 2023, and expected to complete Phase I by Q4 2024 [26]. - The company is developing multiple candidates with high commercial viability, with rights to global development and commercialization for most products as of June 30, 2024 [26]. Research and Development - The company is focused on developing regulatory immune microenvironments through direct modulation of innate and adaptive immune systems [7]. - The company has developed an AICTM platform to enhance the design of antibody-cytokine fusion proteins, aiming to overcome limitations of traditional cytokine therapies [19]. - The AICTM platform enables the production of antibodies with a yield of 4g/L and a purity of 86% in a single affinity chromatography step [37]. - The AEATM platform produces antibodies with 0% fucose content, enhancing ADCC activity by increasing binding affinity to FcγRIIIa by 100 times [38]. - The AIMTM platform focuses on designing multifunctional bioproducts for cancer immunotherapy, allowing exploration of various innate immune stimulators for different clinical applications [39]. - The company emphasizes the importance of R&D investment for long-term growth and competitive advantage, integrating all key biopharmaceutical development functions [40]. - The company aims to address technical challenges and optimize therapeutic effects in immunotherapy development through its innovative platforms [35]. Corporate Governance and Compliance - The company has established an audit committee consisting of three independent non-executive directors [68]. - The company adheres to corporate governance codes and has complied with all applicable provisions since the listing date [65]. - The company has established a strong governance structure with both executive and independent non-executive directors [72]. - The company is committed to adhering to the listing rules set by the Hong Kong Stock Exchange [71]. - The company has implemented a performance evaluation system for employees to determine salary increases, bonuses, or promotions [64]. Market Strategy and Expansion - The company aims to expand its market presence within mainland China, excluding Hong Kong and Macau [72]. - The company is actively pursuing new strategies for market expansion and product development [72]. - The company aims to leverage antibody-cytokine advantages to enhance anti-tumor activity through various mechanisms targeting different pathways [25]. - The company plans to focus on the development of antibody cell factors and expand its GMP-compliant production facilities to enhance production capacity [43]. - The company aims to actively seek international collaboration opportunities to maximize asset value and enhance global brand recognition [43]. Financial Position and Assets - As of June 30, 2024, the total cash and cash equivalents amounted to approximately RMB 493.9 million, an increase of approximately 294.9% compared to RMB 125.1 million as of December 31, 2023 [53]. - The current assets as of June 30, 2024, were approximately RMB 514.5 million, while current liabilities were approximately RMB 34.8 million [53]. - The debt-to-asset ratio as of June 30, 2024, decreased to approximately 6.7% from approximately 135.8% as of December 31, 2023 [56]. - Capital commitments as of June 30, 2024, were RMB 25.5 million, primarily related to contracts for equipment purchases and land use rights [58]. - As of June 30, 2024, the group had no pledged or mortgaged assets [60]. - There were no significant contingent liabilities as of June 30, 2024 [59]. Employee and Operational Metrics - The total salary cost for the reporting period is RMB 28.5 million, a decrease from RMB 37.6 million for the same period last year [64]. - The company has 124 employees as of June 30, 2024 [64]. - The company has successfully completed over 30 batches of antibody cytokines, mAb, bsAb, and fusion proteins to meet the needs of preclinical research and early clinical trials [42]. - The company has established a production facility that meets global GMP standards, with a total production capacity of 1,600 liters, including three 200-liter and one 1,000-liter single-use bioreactors [42]. - The company has completed the installation of a 5,000-liter bioreactor production line, which is expected to enhance its ability to produce candidates for Phase III clinical trials and commercialization [42].