德琪医药(06996) - 2025 - 中期业绩

Company Overview The company is a biopharmaceutical firm focused on the research, development, and commercialization of pharmaceutical products, with a strong pipeline and significant financial adjustments in the reporting period Company Information Antengene Corporation Limited, registered in the Cayman Islands, is primarily engaged in the R&D and commercialization of pharmaceutical products - Company Name: Antengene Corporation Limited[2] - Business Scope: Research and commercialization of pharmaceutical products[3] - Reporting Period: Unaudited condensed consolidated results for the six months ended June 30, 2025[3] Financial Highlights For the six months ended June 30, 2025, revenue decreased by 12.5% year-on-year, but loss significantly narrowed by 54.3% due to reduced R&D, selling, and administrative expenses, with adjusted loss also decreasing by 52.2% Interim Condensed Consolidated Financial Highlights for the Six Months Ended June 30, 2025 | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 53,182 | 60,779 | -12.5% | | Other income and gains | 38,126 | 27,317 | +39.6% | | R&D costs | (79,935) | (130,841) | -38.9% | | Selling and distribution expenses | (36,990) | (56,028) | -34.0% | | Administrative expenses | (39,304) | (58,478) | -32.8% | | Loss for the period | (76,378) | (167,033) | -54.3% | | Adjusted loss for the period* | (72,858) | (152,567) | -52.2% | *Excluding equity-settled share-based payment expenses - Revenue decrease primarily due to 2023 December Selinexor's inclusion in the medical insurance catalog, followed by market demand rationalization, but increased by RMB 22.0 million in H1 2025 compared to H2 2024, reflecting steady growth[5] - Increase in other income and gains mainly attributed to higher government grants[5] - Reduction in R&D, selling and distribution, and administrative expenses primarily due to decreased drug development expenses, employee costs, and market development expenses, reflecting enhanced R&D efficiency and continuous cost control[5][6] Business Highlights During the reporting period, the company achieved significant progress in its product pipeline and operations, including Selinexor's medical insurance inclusion and new indication approvals in multiple APAC regions, positive advancements in several clinical and preclinical assets, and plans to increase investment in AI for next-generation T-cell engager pipeline development - Selinexor (XPOVIO®) approved for inclusion in National Health Insurance in Taiwan, China, and received New Drug Application (NDA) approval for three indications in Indonesia[8] - Phase II CLINCH study for ATG-022 (Claudin 18.2 antibody-drug conjugate) is ongoing in Mainland China and Australia, with a global clinical collaboration with MSD to evaluate its efficacy in combination with KEYTRUDA®[8] - Phase I STAMINA trial for ATG-037 (CD73 inhibitor) completed, with plans to initiate Phase II; combination therapy showed 100% disease control rate in CPI-resistant melanoma patients[11] - I/II phase TORCH-2 study data for ATG-008 (mTORC1/2 inhibitor) combined with toripalimab showed potential for significant clinical benefit in CPI-resistant cervical cancer patients[11] - Steady progress achieved with the company's novel "2+1" T-cell engager platform AnTenGager™, with plans to establish a dedicated AI department to accelerate the development of next-generation proprietary TCE pipeline[13] - The company adheres to a "combination and complementary" R&D strategy, focusing on discovering, developing, and commercializing global first-in-class, only-in-class, and/or best-in-class therapies[14] Management Discussion and Analysis This section provides an in-depth review of the company's vision, financial performance, pipeline advancements, R&D strategies, and future outlook, highlighting key achievements and strategic directions Vision and Overview Antengene is an APAC biopharmaceutical company focused on innovative oncology drugs, committed to discovering, developing, and commercializing global first-in-class, only-in-class, and/or best-in-class therapies to improve patient lives, with a robust pipeline including one commercialized product and five clinical-stage projects - Company Vision: Discover, develop, and commercialize global first-in-class, only-in-class, and/or best-in-class therapies to treat patients across borders and improve their quality of life[15] - Company Positioning: A commercial-stage biopharmaceutical company in the Asia-Pacific region, focused on innovative oncology drugs since its operation in 2017[16] - R&D Pipeline: Includes one commercial-stage product, five clinical-stage projects, and multiple preclinical-stage projects, adopting a "combination and complementary" R&D strategy[16] - Selinexor (XPOVIO®) has received NDA approvals in multiple APAC regions[16] Financial Performance Analysis During the reporting period, the company's revenue decreased year-on-year, but strict cost control led to significant reductions in R&D, selling, and administrative expenses, resulting in a substantial narrowing of both loss for the period and adjusted loss, with increased government grants also contributing positively to other income and gains Key Financial Data for the Six Months Ended June 30, 2025 | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | YoY Change (RMB thousands) | | :--- | :--- | :--- | :--- | | Revenue | 53,182 | 60,779 | (7,597) | | Other income and gains | 38,126 | 27,317 | 10,809 | | R&D costs | (79,935) | (130,841) | 50,906 | | Selling and distribution expenses | (36,990) | (56,028) | 19,038 | | Administrative expenses | (39,304) | (58,478) | 19,174 | | Loss for the period | (76,378) | (167,033) | 90,655 | | Adjusted loss for the period | (72,858) | (152,567) | 79,709 | Revenue and Gross Profit Revenue decreased from RMB 60.8 million in H1 2024 to RMB 53.2 million in H1 2025, primarily due to market demand rationalization after Selinexor's inclusion in medical insurance in December 2023, but showed steady growth compared to H2 2024 - Revenue decreased from RMB 60.8 million in H1 2024 to RMB 53.2 million in H1 2025, mainly impacted by market demand rationalization after medical insurance inclusion in December 2023[79] - Despite the year-on-year decrease, H1 2025 revenue increased by RMB 22.0 million compared to H2 2024, indicating steady growth and stable conditions[79] Other Income and Gains Other income and gains increased by RMB 10.8 million from RMB 27.3 million in H1 2024 to RMB 38.1 million in H1 2025, primarily due to increased government grants - Other income and gains increased by RMB 10.8 million from RMB 27.3 million in H1 2024 to RMB 38.1 million in H1 2025, mainly attributed to increased government grants[80] Research and Development Costs R&D costs decreased by RMB 50.9 million from RMB 130.8 million in H1 2024 to RMB 79.9 million in H1 2025, primarily due to reduced drug development expenses and R&D employee costs, reflecting improved R&D efficiency - R&D costs decreased by RMB 50.9 million from RMB 130.8 million in H1 2024 to RMB 79.9 million in H1 2025[81] - The decrease was mainly due to reduced drug development expenses and R&D employee costs, reflecting the gradual settlement of late-stage assets and improved R&D efficiency[81] R&D Cost Components | Component | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Employee costs | 36,695 | 51,327 | | - Equity-settled share-based payment expenses | 2,457 | 9,171 | | Depreciation and amortization | 2,790 | 6,312 | | Drug development expenses | 36,830 | 62,479 | | Professional fees | 342 | 7,574 | | Others | 3,278 | 3,149 | | Total | 79,935 | 130,841 | Selling and Distribution Expenses Selling and distribution expenses decreased by RMB 19.0 million from RMB 56.0 million in H1 2024 to RMB 37.0 million in H1 2025, mainly due to reduced market development expenses and commercial employee costs, reflecting enhanced promotion efficiency and continuous cost control - Selling and distribution expenses decreased by RMB 19.0 million from RMB 56.0 million in H1 2024 to RMB 37.0 million in H1 2025[83] - The decrease was mainly due to reduced market development expenses and commercial employee costs, reflecting enhanced promotion efficiency and continuous cost control[83] Selling and Distribution Expense Components | Component | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Employee costs | 9,157 | 12,603 | | - Equity-settled share-based payment expenses | 80 | 1,151 | | Market development expenses | 27,520 | 42,729 | | Depreciation and amortization | 171 | 317 | | Others | 142 | 379 | | Total | 36,990 | 56,028 | Administrative Expenses Administrative expenses decreased by RMB 19.2 million from RMB 58.5 million in H1 2024 to RMB 39.3 million in H1 2025, primarily due to reduced employee costs, reflecting improved operational efficiency - Administrative expenses decreased by RMB 19.2 million from RMB 58.5 million in H1 2024 to RMB 39.3 million in H1 2025[85] - The decrease was mainly due to reduced employee costs, reflecting improved operational efficiency[85] Administrative Expense Components | Component | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Employee costs | 20,707 | 33,714 | | - Equity-settled share-based payment expenses | 983 | 4,144 | | Professional fees | 6,717 | 9,878 | | Depreciation and amortization | 6,787 | 6,617 | | Others | 5,093 | 8,269 | | Total | 39,304 | 58,478 | Loss for the Period and Adjusted Loss Loss for the period significantly decreased from RMB 167.0 million in H1 2024 to RMB 76.4 million in H1 2025, primarily due to reduced R&D, selling and distribution, and administrative expenses, with adjusted loss also showing a substantial reduction - Loss for the period decreased from RMB 167.0 million in H1 2024 to RMB 76.4 million in H1 2025, mainly due to reduced R&D, selling and distribution, and administrative expenses[6] - Adjusted loss for the period (excluding equity-settled share-based payment expenses) decreased by 52.2% from RMB 152.6 million in H1 2024 to RMB 72.9 million in H1 2025[7] Reconciliation of Loss and Adjusted Loss | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Loss for the period | (76,378) | (167,033) | | Add: Equity-settled share-based payment expenses | 3,520 | 14,466 | | Adjusted loss for the period | (72,858) | (152,567) | Pipeline Progress Antengene's pipeline focuses on oncology and autoimmune diseases, comprising one commercialized asset, five clinical-stage, and multiple preclinical-stage projects, with significant advancements in Selinexor's market access and other clinical candidates - The company's pipeline focuses on oncology and autoimmune diseases, including one commercial-stage asset, five clinical-stage projects, and multiple preclinical-stage projects[17] Commercialized Products Selinexor (ATG-010, XPOVIO®), the company's first commercialized product, is an oral selective nuclear export inhibitor (SINE) for various hematological malignancies and solid tumors, achieving significant market access and new indication approvals in multiple APAC regions - Selinexor (ATG-010, XPOVIO®) is the company's first commercialized product, an oral Selective Nuclear Export Inhibitor (SINE) for treating various hematological malignancies and solid tumors[21] - In February 2025, XPOVIO® was approved for inclusion in the National Health Insurance in Taiwan, China; in March 2025, Indonesia's BPOM approved its NDA for three indications[8][26][27] - As of June 30, 2025, XPOVIO® has received NDA approvals in Mainland China, South Korea, Singapore, Australia, Malaysia, Thailand, Taiwan, China, Hong Kong, China, Macau, China, and Indonesia[27] - The company is conducting a Phase II/III registration trial in Mainland China for XPOVIO® in combination with R-GDP for rrDLBCL[27] Other Clinical Stage Candidates Several clinical-stage candidates are progressing, including ATG-022, which received US FDA orphan drug designation and entered a global clinical collaboration with MSD, and ATG-037, which completed its Phase I trial - ATG-022 (Claudin 18.2 antibody-drug conjugate) Phase II CLINCH study is ongoing in China and Australia, and received US FDA orphan drug designation for gastric and pancreatic cancer[28] - In May 2025, a global clinical collaboration was established with MSD to evaluate the efficacy of ATG-022 in combination with KEYTRUDA® for advanced solid tumors[8][28] - ATG-037 (CD73 inhibitor) Phase I STAMINA trial completed dosing, and the Ib/II phase has been initiated[29] - ATG-031 (CD24 antibody) PERFORM Phase I trial is undergoing dose escalation in the US[29] - ATG-101 (PD-L1x4-1BB bispecific antibody) Phase I study is undergoing dose escalation in Australia, China, and the US, and received US FDA orphan drug designation for pancreatic cancer[29] Other Late-Stage Candidates The I/II phase TORCH-2 study for ATG-008 (onatasertib, mTORC1/2 inhibitor) in combination with toripalimab has been completed, showing promising clinical benefits for CPI-resistant cervical cancer patients - ATG-008 (onatasertib, mTORC1/2 inhibitor) I/II phase TORCH-2 study in combination with toripalimab has been completed[30] - TORCH-2 study data showed an Overall Response Rate (ORR) of 22.2%, a Disease Control Rate (DCR) of 85.2%, and a median Overall Survival (OS) of 21.4 months for CPI-resistant cervical cancer patients with this combination regimen[11][31] Preclinical Candidates Multiple preclinical candidates, including ATG-042, ATG-201, and ATG-106, are undergoing preclinical research to support future IND/CTA applications - Multiple preclinical candidates, including ATG-042 (PRMT5-MTA inhibitor), ATG-201 (CD19 x CD3 T-cell engager), and ATG-106 (CDH6 x CD3 T-cell engager), are undergoing preclinical research to support IND/CTA applications[12][32][33] Technology Platform and R&D Strategy The company is making steady progress with its novel T-cell engager platform AnTenGager™ and plans to establish a dedicated AI department to accelerate the development of next-generation TCE pipeline, focusing on a "combination and complementary" R&D strategy for cancer treatment - Steady progress achieved with the novel "2+1" T-cell engager platform AnTenGager™, which can enhance efficacy and reduce CRS risk[13][34] - Plans to increase investment and integrate resources to establish a dedicated AI department, equipped with DeepSeek, to accelerate the development of next-generation proprietary TCE pipeline[13][34] - R&D strategy focuses on cancer treatment, adopting a differentiated "combination and complementary" approach to build a pipeline of synergistic first-in-class/best-in-class assets[35] - As of June 30, 2025, the company has nine clinical studies ongoing in Mainland China, the US, and Australia[36] - XPOVIO® has been included in the 2023 National Medical Insurance Catalog, and its new indication (rrDLBCL) was also included in the 2024 National Medical Insurance Catalog, effective January 1, 2025[36] - As of June 30, 2025, the company holds five pending Patent Cooperation Treaty (PCT) applications and eight PCT applications that have entered the national phase[37] Business Development and Future Outlook During the reporting period, the company did not engage in new business development activities, strategically focusing on advancing core R&D programs and enhancing technological capabilities, with future plans to progress clinical-stage product development, build a global and APAC pipeline through external collaborations and internal discovery, and strengthen its commercial team for Selinexor's commercialization - No new business development activities were undertaken during the reporting period, consistent with the strategy of focusing on advancing core R&D programs[14][38] - The company will continue to advance the clinical development of nine clinical-stage products across various therapeutic areas[40] - Will continue to implement a dual-engine approach of external collaboration and internal discovery to build a global and APAC pipeline focused on key oncogenic pathways, tumor microenvironment, tumor-associated antigens, and autoimmune diseases[40] - Will continue to build its commercial team to prepare for the commercialization of XPOVIO® in the APAC region, addressing unmet medical needs[40] Post-Reporting Period Events After the reporting period, Selinexor received new indication approval in China, and ATG-022 was granted Breakthrough Therapy Designation, further enhancing the market potential and development speed of the company's product pipeline - In July 2025, China's NMPA approved XPOVIO® (Selinexor) in combination with bortezomib and dexamethasone for the treatment of adult MM patients who have received at least one prior therapy[39] - In August 2025, ATG-022 was granted Breakthrough Therapy Designation (BTD) by China's NMPA Center for Drug Evaluation (CDE) for the treatment of CLDN18.2-positive, HER2-negative unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma patients[39] Financial Statements This section presents the interim condensed consolidated financial statements, including the statement of profit or loss, comprehensive income, and financial position, providing a snapshot of the company's financial performance and health Interim Condensed Consolidated Statement of Profit or Loss For the six months ended June 30, 2025, the company reported revenue of RMB 53,182 thousand and a gross profit of RMB 42,908 thousand, with the loss for the period significantly narrowing to RMB 76,378 thousand from RMB 167,033 thousand in the prior year Interim Condensed Consolidated Statement of Profit or Loss (For the six months ended June 30) | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Revenue | 53,182 | 60,779 | | Cost of sales | (10,274) | (8,856) | | Gross profit | 42,908 | 51,923 | | Other income and gains | 38,126 | 27,317 | | R&D costs | (79,935) | (130,841) | | Selling and distribution expenses | (36,990) | (56,028) | | Administrative expenses | (39,304) | (58,478) | | Other expenses | (985) | (478) | | Finance costs | (198) | (448) | | Loss before tax | (76,378) | (167,033) | | Income tax expense | – | – | | Loss for the period | (76,378) | (167,033) | | Basic and diluted loss per share attributable to owners of the parent | RMB (0.12) | RMB (0.27) | Interim Condensed Consolidated Statement of Comprehensive Income For the six months ended June 30, 2025, the company's total comprehensive loss for the period significantly decreased to RMB 87,994 thousand from RMB 168,242 thousand in the prior year, primarily due to the narrowed loss for the period Interim Condensed Consolidated Statement of Comprehensive Income (For the six months ended June 30) | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Loss for the period | (76,378) | (167,033) | | Exchange differences on translation of overseas operations | (11,616) | (1,209) | | Other comprehensive loss for the period, net of tax | (11,616) | (1,209) | | Total comprehensive loss for the period | (87,994) | (168,242) | | Attributable to owners of the parent | (87,994) | (168,242) | Interim Condensed Consolidated Statement of Financial Position As of June 30, 2025, the company's total assets were RMB 1,075,557 thousand, with net assets of RMB 766,327 thousand and net current assets of RMB 660,371 thousand, indicating healthy liquidity and debt-to-asset ratios Interim Condensed Consolidated Statement of Financial Position (As of June 30, 2025) | Indicator | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Total non-current assets | 415,186 | 388,577 | | Total current assets | 850,435 | 956,155 | | Total current liabilities | 190,064 | 146,325 | | Net current assets | 660,371 | 809,830 | | Total assets less current liabilities | 1,075,557 | 1,198,407 | | Total non-current liabilities | 309,230 | 347,606 | | Net assets | 766,327 | 850,801 | | Total equity | 766,327 | 850,801 | Notes to the Financial Statements This section provides detailed explanations and breakdowns of the financial statements, covering company information, accounting policies, segment reporting, revenue analysis, loss components, tax, dividends, loss per share, and various payables Company and Group Information Antengene Corporation Limited, an investment holding company incorporated in the Cayman Islands on August 28, 2018, with its shares listed on the Main Board of the Hong Kong Stock Exchange on November 20, 2020, primarily engages in the R&D and commercialization of pharmaceutical products through its subsidiaries - The company was incorporated in the Cayman Islands on August 28, 2018[46] - The company is an investment holding company, with subsidiaries involved in the R&D and commercialization of pharmaceutical products[47] - The company's shares were listed on the Main Board of The Stock Exchange of Hong Kong Limited on November 20, 2020[48] Basis of Preparation and Changes in Accounting Policies The interim condensed consolidated financial information is prepared in accordance with IAS 34 and is consistent with the accounting policies used for the annual consolidated financial statements for the year ended December 31, 2024, with the initial adoption of IAS 21 (Amendments) "Lack of Exchangeability" having no impact on the Group's financial information - The interim condensed consolidated financial information is prepared in accordance with International Accounting Standard 34 "Interim Financial Reporting"[49] - Accounting policies are consistent with the annual consolidated financial statements for the year ended December 31, 2024, except for the initial adoption of IAS 21 (Amendments) "Lack of Exchangeability"[50] - IAS 21 (Amendments) has no impact on the interim condensed consolidated financial information as all the Group's transaction currencies are exchangeable[51] Operating Segments and Geographical Information The Group operates in a single reportable operating segment, the R&D and commercialization of pharmaceutical products, with Mainland China remaining the primary source of revenue, though revenue from other countries/regions has grown, and non-current assets are mainly concentrated in Mainland China - The Group has only one reportable operating segment: the research and development and commercialization of pharmaceutical products[52] Revenue from External Customers (by Geographical Region) | Region | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Mainland China | 43,621 | 53,569 | | Other countries/regions | 9,561 | 7,210 | | Total Revenue | 53,182 | 60,779 | Non-current Assets (by Geographical Region) | Region | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Mainland China | 379,523 | 353,622 | | Other countries/regions | 1,885 | 4,651 | | Total Non-current Assets | 381,408 | 358,273 | Analysis of Revenue, Other Income and Gains The company's revenue primarily stems from the sale of pharmaceutical products, with Mainland China contributing the majority, while other income and gains are mainly composed of government grants, bank interest income, and foreign exchange gains, with government grants showing a significant increase Analysis of Revenue from Customer Contracts | Category | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Type of goods | | | | Sale of pharmaceutical products | 53,182 | 60,779 | | Geographical market | | | | Mainland China | 43,621 | 53,569 | | Other countries/regions | 9,561 | 7,210 | | Timing of revenue recognition | | | | Goods transferred at a point in time | 53,182 | 60,779 | - Performance obligations are satisfied upon delivery of pharmaceutical products, with payments generally due within 60 to 150 days after the billing date[56] Analysis of Other Income and Gains | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Other income | | | | Government grants | 14,614 | 811 | | Bank interest income | 10,270 | 20,292 | | Others | 382 | – | | Other interest income from financial assets | 1 | 1 | | Other gains | | | | Gain on disposal of right-of-use assets from early termination of leases | 624 | – | | Foreign exchange gains | 12,235 | 6,181 | | Fair value change of equity investments | – | 32 | | Total other income and gains | 38,126 | 27,317 | - Government grants refer to subsidies received from local governments with no unfulfilled conditions[56] Components of Loss Before Tax Loss before tax primarily comprises cost of inventories sold, depreciation and amortization, lease payments, and employee benefit expenses; during the reporting period, both employee benefit expenses and depreciation and amortization decreased, while foreign exchange gains positively impacted loss reduction Components of Loss Before Tax (For the six months ended June 30) | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Cost of inventories sold | 10,274 | 8,856 | | Depreciation of property, plant and equipment | 6,257 | 8,149 | | Depreciation of right-of-use assets | 3,250 | 4,763 | | Amortization of other intangible assets | 241 | 334 | | Lease payments not included in the measurement of lease liabilities | 340 | 1,498 | | Total employee benefit expenses | 66,560 | 97,644 | | Foreign exchange gains | (12,235) | (6,181) | | Fair value loss/(gain) on financial assets | 21 | (32) | | Gain on disposal of right-of-use assets from early termination of leases | (624) | – | | Loss on disposal of items of property, plant and equipment | 317 | 43 | - Employee benefit expenses include wages and salaries, contributions to pension schemes, staff welfare expenses, and equity-settled share-based payment expenses[57] Income Tax The Group is subject to income tax in various jurisdictions at local rates, including Hong Kong (16.5%/8.25%), Macau (12%), Mainland China (25%), Australia (25%), Singapore (17%), South Korea (10%), and the US (21% federal + 8.7% state); no income tax provision was made for the reporting period due to the absence of assessable profits - The Group is subject to income tax on profits arising in or derived from the jurisdictions where its member companies are located and operate[58] - Corporate income tax rates in major jurisdictions: Hong Kong 16.5% (partially 8.25%), Macau 12%, Mainland China 25%, Australia 25%, Singapore 17%, South Korea 10%, US federal 21% plus Delaware state 8.7%[61][62][63][64][65][66][67] - No income tax provision was made for the six months ended June 30, 2025, as the Group did not generate any assessable profits[68] Dividends The company did not pay or declare any dividends for the six months ended June 30, 2025 - The company did not pay or declare any dividends for the six months ended June 30, 2025[69] Loss Per Share For the six months ended June 30, 2025, the basic and diluted loss per share attributable to ordinary equity holders of the parent was RMB (0.12), an improvement from RMB (0.27) in the prior year, with outstanding share options and restricted share units having an anti-dilutive effect - The calculation of basic loss per share is based on the loss for the period attributable to ordinary equity holders of the parent and the weighted average number of ordinary shares outstanding during the period, which was 620,441,464 shares[70] - For the six months ended June 30, 2025, basic and diluted loss per share was RMB (0.12) (2024: RMB (0.27))[42] - Outstanding share options and restricted share units had an anti-dilutive effect on the basic loss per share, thus no dilutive adjustment was made[70] Data for Basic and Diluted Loss Per Share Calculation | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Loss for the period attributable to owners of the parent used in calculating basic and diluted loss per share | (76,378) | (167,033) | | Weighted average number of ordinary shares outstanding during the period used in calculating basic and diluted loss per share | 620,441,464 | 618,974,062 | Trade Receivables As of June 30, 2025, total trade receivables amounted to RMB 22,636 thousand, all of which are due within six months Aging Analysis of Trade Receivables | Aging | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Within six months | 22,636 | 18,675 | | Total | 22,636 | 18,675 | Trade Payables As of June 30, 2025, total trade payables amounted to RMB 4,627 thousand, all due within three months and non-interest bearing Aging Analysis of Trade Payables | Aging | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Within three months | 4,627 | 3,579 | | Total | 4,627 | 3,579 | - Trade payables are non-interest bearing and generally settled within two to three months[75] Other Payables and Accruals As of June 30, 2025, total other payables and accruals amounted to RMB 142,711 thousand, primarily comprising deferred income, accrued salaries, payables for property, plant and equipment purchases, and fees for CRO, CDMO, and SMO services Components of Other Payables and Accruals | Item | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Deferred income | 22,317 | 22,987 | | Accrued salaries | 13,478 | 17,455 | | Other taxes payable | 5,697 | 5,730 | | Payables for purchase of property, plant and equipment | 24,574 | 368 | | Other payables and accruals | 76,645 | 72,460 | | Total | 142,711 | 119,000 | - Deferred income refers to government grants related to assets, which will be recognized in profit or loss over the expected useful life of the related assets[78] - Other payables and accruals mainly include accrued or invoiced but unpaid fees for services provided by Contract Research Organizations (CRO), Contract Development and Manufacturing Organizations (CDMO), and Site Management Organizations (SMO)[78] Other Information This section covers various non-financial aspects of the company, including employee and remuneration policies, liquidity and financial resources, investment activities, foreign exchange risk, contingent liabilities, corporate governance, use of listing proceeds, interim results review, public float, and material litigation Employees and Remuneration Policy As of June 30, 2025, the company had 152 employees, with R&D personnel constituting the largest proportion, and provides comprehensive remuneration, benefits, and on-the-job training to support employee career development Number of Employees by Function (As of June 30, 2025) | Function | Number of Employees | % of Total Employees | | :--- | :--- | :--- | | General and Administration | 41 | 27.0 | | R&D | 73 | 48.0 | | Commercialization | 16 | 10.5 | | Manufacturing | 22 | 14.5 | | Total | 152 | 100.0 | - The company has 125 employees in China and 27 employees overseas[90] - Employee remuneration includes salaries, bonuses, provident fund and social insurance contributions, and other benefit payments[90] - The company provides extensive on-the-job training, induction training, and mentorship programs to help employees develop professional knowledge and management skills[90] Liquidity and Financial Resources As of June 30, 2025, the company's cash and bank balances were RMB 794.1 million, with a current ratio of 447.4% and a gearing ratio of 39.5%, indicating healthy liquidity and financial stability - As of June 30, 2025, cash and bank balances were RMB 794.1 million (December 31, 2024: RMB 900.1 million), with the decrease primarily due to operating expenses[91] - Current assets were RMB 850.4 million, and current liabilities were RMB 190.1 million[92] - The current ratio was 447.4% (December 31, 2024: 653.4%)[93] - The gearing ratio was 39.5% (December 31, 2024: 36.7%)[94] Material Investments, Acquisitions and Disposals As of June 30, 2025, the company held no material investments and had no material acquisitions or disposals of subsidiaries, associates, and joint ventures during the reporting period - As of June 30, 2025, the company held no material investments[95] - For the six months ended June 30, 2025, the company had no material acquisitions or disposals of subsidiaries, associates, and joint ventures[95] Future Plans for Material Investments or Capital Assets As of June 30, 2025, the company had no specific plans for material investments or capital assets - As of June 30, 2025, the company had no specific plans for material investments or capital assets[96] Foreign Exchange Risk The company is exposed to transactional currency risk, with a significant portion of bank balances and interest receivables denominated in foreign currencies; currently, there is no foreign exchange hedging policy, but management monitors and considers hedging significant foreign exchange risks when necessary - The company is exposed to transactional currency risk, with a majority of bank balances and interest receivables denominated in foreign currencies[97] - Currently, there is no foreign exchange hedging policy, but management monitors foreign exchange risk and will consider hedging when necessary[97] Contingent Liabilities and Pledged Assets As of June 30, 2025, the company had no material contingent liabilities and had pledged leased land totaling RMB 41.8 million to secure bank financing - As of June 30, 2025, the company had no material contingent liabilities[98] - The Group has pledged leased land totaling RMB 41.8 million to secure bank financing[99] Corporate Governance and Securities Transactions The company is committed to maintaining high standards of corporate governance and complies with the Corporate Governance Code, with the Chairman and CEO roles held by the same individual, an arrangement the Board believes facilitates strategy execution and communication, supported by sufficient checks and balances; directors and relevant employees adhere to the Standard Securities Dealing Code - The company complies with the Corporate Governance Code set out in Appendix C1 Part 2 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited[100] - The roles of Chairman and Chief Executive Officer are held by the founder, Dr. Jianming Mei, an arrangement the Board believes facilitates strategy execution and information communication[100] - The Board of Directors comprises two executive directors and three independent non-executive directors, ensuring sufficient checks and balances[101] - All directors confirmed compliance with the Standard Securities Dealing Code for Directors of Listed Issuers during the reporting period[102] - During the reporting period, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities[103] Use of Proceeds from Listing The net proceeds from the initial public offering were approximately RMB 2,274.70 million, with an unutilized net amount of approximately RMB 376.61 million as of June 30, 2025; a portion of the proceeds was reallocated on March 22, 2024, and the remaining funds are expected to be fully utilized by December 31, 2026 - Net proceeds from the initial public offering were approximately RMB 2,274.70 million[104] - As of June 30, 2025, the total unutilized net proceeds amounted to approximately RMB 376.61 million[104] - On March 22, 2024, the Board resolved to reallocate approximately RMB 553.93 million of unutilized net proceeds to "fund ongoing preclinical research and planned clinical trials for other preclinical candidates in our pipeline"[108] - The unutilized net proceeds of RMB 376.61 million as of June 30, 2025, are expected to be fully utilized by December 31, 2026[108] Use of Net Proceeds from Listing | Purpose | Original Allocation (RMB million) | After Revised Allocation (RMB million) | Unutilized as of Dec 31, 2024 (RMB million) | Actual Use during Reporting Period (RMB million) | Unutilized as of June 30, 2025 (RMB million) | Expected Full Utilization Timeline | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Clinical trials and commercialization of core products | 932.63 | 932.63 | – | – | – | Not applicable | | Clinical trials for other clinical-stage candidates | 568.67 | 117.29 | 2.29 | 0.14 | 2.15 | By December 31, 2026 | | Research and clinical trials for preclinical candidates | 204.72 | 758.65 | 391.17 | 43.39 | 347.78 | By December 31, 2026 | | Pipeline expansion and business development | 318.46 | 215.91 | 29.44 | 2.76 | 26.68 | By December 31, 2026 | | Capital expenditure | 22.75 | 22.75 | – | – | – | Not applicable | | General corporate purposes | 227.47 | 227.47 | – | – | – | Not applicable | | Total | 2,274.70 | 2,274.70 | 422.90 | 46.29 | 376.61 | | Review of Interim Results The Audit Committee has reviewed the accounting principles and practices adopted by the Group and discussed internal controls and financial reporting matters with management, while external auditor Ernst & Young has conducted an independent review of the interim financial information - The Audit Committee, composed of three independent non-executive directors, has reviewed the accounting principles and practices adopted by the Group[105] - External auditor Ernst & Young has conducted an independent review of the interim financial information in accordance with Hong Kong Standard on Review Engagements 2410[105] Public Float and Material Litigation Since the listing date, at least 25% of the company's total issued shares have been held by the public, complying with Listing Rules; during the reporting period, the company was not involved in any material litigation or arbitration - Since the listing date, at least 25% of the company's total issued shares have been held by the public, in compliance with the Listing Rules[106] - During the reporting period, the company was not involved in any material litigation or arbitration, and the directors are unaware of any pending or threatened material litigation or claims against the Group[107] Interim Dividend and Publication of Report The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025; the interim results announcement has been published on the HKEX and company websites, and the interim report will be published in September 2025 - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025[109] - The interim results announcement has been published on the HKEX website and the company's website[110] - The interim report for the six months ended June 30, 2025, will be published on the HKEX and company websites in September 2025[110]