思路迪医药股份(01244) - 2025 - 中期业绩

Company Overview and Business Highlights The company capitalized on the Hong Kong capital market recovery in H1 2025, particularly in biotechnology, achieving breakthroughs in R&D, early-stage research, Envafolimab® indications, and nuclear medicine and mRNA platforms, entering a new phase of "dual-driven growth and global innovation breakthroughs" Business Summary The company achieved significant breakthroughs in R&D, early-stage research, Envafolimab® indications, and nuclear medicine and mRNA platforms, entering a new phase of dual-driven growth and global innovation - The Hong Kong capital market recovered in H1 2025, with biotechnology ETFs performing strongly, presenting opportunities for the company[4] - The company prudently increased early-stage research, guided by forward-looking clinical needs, and successfully expanded Envafolimab® indications[4] - Multiple proprietary nuclear medicine and mRNA platform products with global intellectual property rights are advancing clinical research[4] - The company entered a new era of "dual-driven growth and global innovation breakthroughs," deepening global strategic collaborations[4] Strategic Transformation and Core Platforms The company is strategically shifting from chronic tumor management to prevention of metastasis and recurrence, leveraging RDC and LNP-mRNA platforms to establish a tumor prevention system driven by unmet medical needs and technological advancements - The company's strategy expanded from chronic tumor management and precision therapy to preventing tumor metastasis and recurrence, aiming to establish a tumor prevention system via RDC and LNP-mRNA platforms[18] - This strategic evolution is driven by unmet medical needs, technological advancements, and the company's positioning, adapting to the trend of tumor chronicity[18][19] - The RDC platform has established a full closed-loop R&D system covering molecular design, screening, and preclinical evaluation, focusing on PSMA and FAP targets[19] - The AI-driven LNP-mRNA platform shows promising prospects in tumor vaccines, offering high specificity, good safety, strong efficacy, and durable immunity[19] Financial Performance The company's financial performance for the period shows a narrowed comprehensive loss, driven by stable revenue and effective cost control Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, the company reported revenue of RMB 209,167 thousand, gross profit of RMB 192,907 thousand, and a total comprehensive loss of RMB 92,634 thousand, which narrowed compared to the prior year period Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | Change (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | 209,167 | 206,422 | 2,745 | 1.3% | | Cost of sales | (16,260) | (17,473) | 1,213 | -6.9% | | Gross profit | 192,907 | 188,949 | 3,958 | 2.1% | | Other income and net gains | 17,700 | 22,437 | (4,737) | -21.1% | | Research and development expenses | (83,121) | (85,291) | 2,170 | -2.5% | | Administrative expenses | (29,735) | (43,504) | 13,769 | -31.6% | | Selling and marketing expenses | (111,547) | (110,078) | (1,469) | 1.3% | | Royalty fees | (17,637) | (15,619) | (2,018) | 12.9% | | Other expenses | (55,050) | (61,134) | 6,084 | -9.9% | | Finance costs | (3,303) | (5,063) | 1,760 | -34.8% | | Impairment losses on financial assets | (2,903) | (4,771) | 1,868 | -39.2% | | Loss before tax | (92,689) | (114,074) | 21,385 | -18.7% | | Income tax expense | 55 | – | 55 | N/A | | Total comprehensive loss for the period | (92,634) | (114,074) | 21,440 | -18.8% | Revenue and Gross Profit Analysis During the reporting period, the company's revenue primarily stemmed from Envafolimab® sales, increasing 1.3% to RMB 209.2 million, with gross profit rising 2.1% to RMB 192.9 million and gross margin slightly increasing to 92.2%, driven by higher sales volume and reduced surcharges - Revenue primarily from Envafolimab® sales, increasing 1.3% year-on-year to RMB 209.2 million[10][49] - Gross profit increased 2.1% year-on-year to RMB 192.9 million, with gross margin slightly rising from 91.5% to 92.2%[12][51] - Cost of sales decreased 6.9% to RMB 16.3 million, primarily due to reduced related surcharges and taxes[11][50] Expense Analysis The company effectively controlled various expenses during the reporting period, with R&D and administrative expenses decreasing, selling and marketing expenses remaining stable, and royalty fees increasing due to higher sales volume Research and Development Expenses R&D expenses decreased 2.5% year-on-year to RMB 83.1 million, primarily due to reduced employee welfare expenses related to R&D personnel - R&D expenses decreased 2.5% year-on-year to RMB 83.1 million[13][53] - The decrease was primarily attributable to a RMB 2.6 million reduction in employee welfare expenses related to R&D personnel[13][53] Selling and Marketing Expenses Selling and marketing expenses increased 1.3% year-on-year to RMB 111.5 million, primarily due to increased Envafolimab® sales, with the expense ratio remaining stable at 53.3%, reflecting a mature business model - Selling and marketing expenses increased 1.3% year-on-year to RMB 111.5 million[14][55] - The expense ratio remained stable at 53.3% in both H1 2024 and H1 2025, indicating a mature business model[14][55] Administrative Expenses Administrative expenses significantly decreased 31.6% year-on-year to RMB 29.7 million, primarily due to reductions in share-based payment expenses, legal and professional fees, and depreciation and amortization expenses - Administrative expenses decreased by RMB 13.8 million year-on-year to RMB 29.7 million[54] - The decrease was primarily due to a RMB 1.8 million reduction in share-based payment expenses, a RMB 6.8 million reduction in legal and professional fees, and a RMB 5.5 million reduction in depreciation and amortization expenses[54] Royalty Fees and Other Expenses Royalty fees increased 12.9% year-on-year to RMB 17.6 million due to higher Envafolimab® sales, while other expenses primarily included donations and net exchange losses - Royalty fees increased by RMB 2.0 million year-on-year to RMB 17.6 million, primarily due to increased Envafolimab® sales volume[56] - Other expenses primarily included donations of RMB 51.192 million and net exchange losses of RMB 3.612 million[98] Loss Performance Total comprehensive loss for the period decreased 18.8% year-on-year to RMB 92.6 million, primarily benefiting from increased gross profit due to sales growth and excellent administrative expense control - Total comprehensive loss for the period decreased by RMB 21.5 million year-on-year to RMB 92.6 million[15][57] - The reduction in loss was primarily attributable to a RMB 4.0 million increase in gross profit and RMB 13.8 million in administrative expense savings[15] Non-IFRS Measures Adjusted total comprehensive loss for the period narrowed to RMB 72.151 million from RMB 97.659 million in the prior year, supplementing IFRS loss measures by adding back share-based payment expenses Non-IFRS Measures | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | Change (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total comprehensive loss for the period | (92,634) | (114,074) | 21,440 | -18.8% | | Add: Share-based payment expenses | 20,483 | 16,415 | 4,068 | 24.8% | | Adjusted total comprehensive loss for the period | (72,151) | (97,659) | 25,508 | -26.1% | - Adjusted loss and total comprehensive loss for the period are calculated by adding back share-based payment expenses, aiming to provide a more comprehensive assessment of operating performance[16][58] Condensed Consolidated Statement of Financial Position As of June 30, 2025, total assets were RMB 1,141,975 thousand, a decrease from RMB 1,216,256 thousand at year-end 2024, with net current assets declining from RMB 499,963 thousand to RMB 297,712 thousand Condensed Consolidated Statement of Financial Position | Metric | 2025 June 30 (RMB thousands) | 2024 Dec 31 (RMB thousands) | Change (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total non-current assets | 339,376 | 228,505 | 110,871 | 48.5% | | Total current assets | 802,599 | 987,751 | (185,152) | -18.7% | | Total assets | 1,141,975 | 1,216,256 | (74,281) | -6.1% | | Total non-current liabilities | 5,021 | 24,754 | (19,733) | -79.7% | | Total current liabilities | 504,887 | 487,788 | 17,099 | 3.5% | | Total liabilities | 509,908 | 512,542 | (2,634) | -0.5% | | Net assets | 632,067 | 703,714 | (71,647) | -10.2% | Liquidity and Cash Flows As of June 30, 2025, total current assets were RMB 802.6 million, with cash and bank balances totaling RMB 615.3 million, a RMB 225.7 million decrease from year-end 2024, primarily due to reduced bank loans and payment for strategic cooperation consideration, resulting in a net cash outflow of RMB 205.8 million from operating activities - Total current assets were RMB 802.6 million, and cash and bank balances totaled RMB 615.3 million, a RMB 225.7 million decrease from year-end 2024[61] - The decrease in cash was primarily due to reduced bank loans resulting from timing differences in loan renewals and payment of strategic cooperation consideration to Qingdao Hainuo[61] - Net cash used in operating activities was RMB 205.8 million, net cash used in investing activities was RMB 94.3 million, and net cash used in financing activities was RMB 75.6 million[62] Product Pipeline and R&D Progress The company's product pipeline demonstrates significant progress in commercialization and clinical development, particularly for Envafolimab®, RDC, and AI LNP-mRNA platforms, alongside other promising investigational drugs Envafolimab® Envafolimab®, China's sole commercialized subcutaneous PD-L1 inhibitor, achieved RMB 209.2 million in sales revenue in H1 2025, a 1.3% year-on-year increase, with clinical research results presented at ASCO and inclusion in 19 authoritative clinical guidelines, marking the full launch of its global commercialization Commercialization Progress Envafolimab® achieved RMB 209.2 million in sales revenue in H1 2025, a 1.3% year-on-year increase, with total sales reaching approximately RMB 1.9 billion, now sold in over 3,000 hospitals and 760+ pharmacies across 30 provinces and 305 cities in China, included in 36 city-level "Huiminbao" schemes, and with a global commercialization strategy initiated through an overseas licensing agreement with Glenmark - Envafolimab® H1 sales revenue reached RMB 209.2 million, a 1.3% year-on-year increase[5][20] - It has been included in 19 latest authoritative Chinese and international clinical guidelines and consensuses[5][21][29] - It is sold in over 3,000 hospitals and 760+ pharmacies across 30 provinces and 305 cities in China, and included in 36 city-level "Huiminbao" schemes[43] - An overseas licensing agreement has been reached with Glenmark, fully initiating its global commercialization strategy[21] Clinical Research Results Envafolimab® presented 11 research findings at the 2025 ASCO Annual Meeting, covering various tumor types including high tumor mutational burden advanced solid tumors, extensive-stage small cell lung cancer, resectable non-small cell lung cancer, biliary tract cancer, pancreatic cancer, esophageal squamous cell carcinoma, and sarcoma, with both monotherapy and combination regimens demonstrating significant efficacy and good safety - 11 research findings were presented at the ASCO Annual Meeting, covering 7+ tumor types, including high tumor mutational burden advanced solid tumors, small cell lung cancer, and non-small cell lung cancer[5][26] - Monotherapy for advanced solid tumor patients with tTMB≥13 mut/Mb achieved an ORR of 33.3% and a mDOR of up to 20.2 months[5][26] - First-line combination with chemotherapy for extensive-stage small cell lung cancer achieved an ORR of 87.1% and a median OS of 20 months[5][27] - Neoadjuvant therapy for resectable non-small cell lung cancer achieved an MPR of 40% and a pCR of 20%, with the added convenience of subcutaneous administration[7][27] - Combination with recombinant human endostatin and chemotherapy for advanced squamous non-small cell lung cancer achieved an ORR of 65.4% and a median OS of 24.6 months[7][28] Guideline Recommendations As of June 2025, Envafolimab® has received recommendations in 19 latest authoritative domestic and international clinical guidelines and expert consensuses, covering various cancer types including cervical, uterine, ovarian, gastric, colorectal, lung, and esophageal cancers, further solidifying its clinical position - Envafolimab® has been recommended in 19 latest authoritative domestic and international clinical guidelines and expert consensuses[29] - Recommendations include NCCN guidelines (cervical cancer, uterine tumors, ovarian cancer) and CSCO guidelines (endometrial cancer, cervical cancer, ovarian cancer, immune checkpoint inhibitors, gastric cancer, colorectal cancer, lung cancer, esophageal cancer, etc)[29] Radioligand Drug Conjugate (RDC) Platform The company has established a comprehensive RDC platform covering molecular design, screening, and preclinical evaluation, focusing on PSMA and FAP targets, with its first self-developed 177Lu-labeled PSMA-targeted RDC drug 3D1015 entering investigator-initiated trial (IIT) phase, demonstrating significant differentiated advantages and excellent safety in preclinical studies - A complete platform covering RDC molecular design, screening, and preclinical evaluation has been established, forming a full closed-loop R&D system[6][19] - Radionuclide selection covers ⁶⁸Ga, ¹⁷⁷Lu, and ²²⁵Ac, with a focus on developing PSMA and FAP targets[6][19] - The first self-developed ¹⁷⁷Lu-labeled PSMA-targeted RDC drug 3D1015 has entered the IIT phase, with preclinical studies showing significant tumor inhibition even at one-tenth the dose of Pluvicto[6][32][33] - A FAP-targeted ligand demonstrated excellent binding affinity in in vitro experiments and is currently undergoing preclinical evaluation[6] AI LNP-mRNA Platform The company has successfully localized its AI-mRNA technology platform, possessing full intellectual property rights and global commercialization rights, with its first off-the-shelf tumor vaccine 3D124 (based on the self-developed "3D-PreciseAg" platform and 3D-B051-LNP delivery system) planned for IND submission in Q1 2026, and multiple innovative therapies for hematological and solid tumors under development - Successfully localized the AI-mRNA technology platform, possessing full intellectual property rights and global commercialization rights[8] - The first off-the-shelf tumor vaccine 3D124 (targeting multiple tumor antigens such as KRAS, NRAS, EGFR) is planned for IND submission in Q1 2026[8][33][34] - The self-developed LNP delivery system (3D-B051-LNP) has filed a PCT international patent application and is highly effective in inducing cellular and humoral immune responses[23][34] - The pipeline also includes the 3D125 tumor vaccine for small cell lung cancer and in vivo CAR-T projects based on mRNA technology[8] Other Pipeline Products Other pipeline products include 3D185 (FGFR1/2/3 inhibitor) with smooth Phase I trial progress, 3D189 (WT1 peptide vaccine) with Phase I recruitment completed and positive IDMC evaluation for its global Phase III multicenter clinical study, as well as 3D057 (PD-L1 and CD3 bispecific antibody) and 3D062 (KRAS mutation inhibitor) - 3D185 (FGFR1/2/3 inhibitor) Phase I clinical trial is progressing smoothly, aiming to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy[30] - 3D189 (WT1 peptide vaccine) Phase I clinical study completed patient enrollment in China, with no new safety signals observed and WT1-specific immune responses noted[31] - The global Phase III REGAL trial of 3D189 (in collaboration with SELLAS) has received four positive evaluations from the Independent Data Monitoring Committee (IDMC), supporting its continued advancement[31] - 3D057, a PD-L1 and CD3 bispecific antibody developed based on the ALiCE platform, is steadily advancing in non-clinical studies[35] - 3D062, an internally developed KRAS mutation inhibitor, has filed a new Chinese patent application[35] Operations and Management The company demonstrates robust operational and management capabilities, supported by strong R&D platforms, global GMP-compliant production, patient-centric commercialization strategies, extensive intellectual property, and a dedicated workforce R&D Capabilities and Platforms The company possesses an experienced management team and robust R&D platforms, encompassing large and small molecule drug development, cell line screening, compound screening, and newly established LNP key component synthesis and screening platforms, supporting tumor neoantigen vaccine development with its proprietary 3D-PreciseAg antigen prediction system and nucleic acid drug R&D system, while actively exploring new combinations of TCE bispecific antibodies/bispecific antibody-ADCs - Possesses an experienced management team and strong molecular design and screening capabilities, enhancing drug development success rates[37] - The R&D center covers large molecule, small molecule drug R&D platforms, cell line screening platforms, and compound screening platforms[37] - A new LNP key component ionizable cationic lipid synthesis and screening platform has been established to support nucleic acid drug pipeline development[37] - Independently developed the 3D-PreciseAg antigen prediction system, combined with the LNP delivery system, laying the foundation for tumor vaccine development[37] - Actively exploring new combinations of TCE bispecific antibodies/bispecific antibody-ADCs and novel administration routes such as high-concentration formulation robotic capsule oral delivery[38] Production and Quality Management The company is constructing internal production facilities in Xuzhou, Jiangsu, compliant with global GMP standards, and collaborates with CMOs for manufacturing, having established a full-process quality management system covering non-clinical development, clinical research, and commercial production, and obtained NMPA approval to expand Envafolimab® injection capacity - Constructing internal production facilities in Xuzhou, Jiangsu, compliant with FDA, EMA, and China NMPA GMP standards[40] - Collaborating with qualified CMOs for preclinical and clinical supply manufacturing, and plans to continue outsourcing commercial-scale production[40] - A full-process quality management system centered on GLP, GCP, and GMP has been established to ensure compliance with international and domestic regulatory standards[41] - The production capacity for Envafolimab® injection received formal approval for expansion from the NMPA in H1 2025[42] Commercialization Strategy The company is committed to accelerating Envafolimab®'s commercialization through patient-centric marketing strategies and academic promotion activities, having established a professional sales and marketing department and actively conducting pre-launch preparations for upcoming commercial products - Committed to accelerating Envafolimab® commercialization through patient-centric marketing strategies and academic promotion activities[43] - A professional sales and marketing department has been established, responsible for product positioning, market strategy, promotional activity planning, and patient assistance[43] - Actively conducting pre-launch preparations for upcoming commercial products[44] Intellectual Property The company holds an extensive patent portfolio, including 13 granted patents in China, 24 granted patents in other jurisdictions, and 19 pending patent applications, protecting its products, drug candidates, and technologies - Possesses an extensive patent portfolio, including 13 granted patents in China and 24 granted patents overseas[45] - Holds 19 pending patent applications, including 12 in China and 7 in other jurisdictions[45] Employees and Remuneration As of June 30, 2025, the company had 183 full-time employees, with total employee welfare expenses of approximately RMB 63.4 million, emphasizing recruitment, continuous training, and performance evaluation in compliance with Chinese labor laws - As of June 30, 2025, the Group had 183 full-time employees[66] - Total employee welfare expenses were approximately RMB 63.4 million, including salaries, social insurance, benefits, and share-based awards[66] - The company recruits employees based on work experience, educational background, etc., and provides continuous education and training programs[66] Future Outlook and Strategy The company is committed to sustainable growth and global innovation, accelerating product development and commercialization, enhancing operational efficiency, and expanding Envafolimab®'s global value through strategic partnerships Future Plans The company will continue to pursue sustainable growth and global innovation strategic goals, accelerating product development and commercialization, enhancing operational efficiency, continuously producing diversified innovative drugs through AI+mRNA and nuclear medicine technology platforms, and expanding Envafolimab®'s global commercial value with partners - Committed to achieving sustainable growth and global innovation strategic goals, accelerating product development and commercialization, and enhancing operational efficiency[67] - The AI+mRNA platform will continue to generate diversified mRNA drugs and proprietary LNP libraries[69] - The nuclear medicine technology platform will meticulously develop first-generation beta-radionuclide nuclear medicine products and explore effective products with different radionuclides[69] - Will expand Envafolimab®'s development and commercialization into new markets with partners, maximizing product commercial value through further clinical studies[68][69] Post-Reporting Period Events Post-reporting period, the company signed a strategic cooperation agreement with Qingdao Hainuo, paying RMB 98.0 million to unfreeze bank accounts and withdraw lawsuits, and plans to acquire Qingdao Hainuo's equity in 3D Medicines Shanghai Co., Ltd. within 5 years, additionally entering a strategic cooperation framework agreement with Kaituo Bio to deepen mRNA collaboration - Signed a strategic cooperation agreement with Qingdao Hainuo, paying RMB 98.0 million consideration to lift preservation orders and withdraw lawsuits[69] - Plans to acquire Qingdao Hainuo's equity in 3D Medicines Shanghai Co., Ltd. within 5 years, with the paid consideration to be offset against the equity acquisition price[70] - Entered into a strategic cooperation framework agreement with Kaituo Bio, deepening collaboration in targeted LNP delivery, tumor vaccines, and in vivo CAR-T/NK based on the AI+mRNA R&D platform and LNP delivery system[71] Capital Utilization and Corporate Governance This section details the company's capital allocation from its listing and 2023 placing, its dividend policy, and adherence to high corporate governance standards, including board structure and securities trading codes Use of Net Proceeds from Listing As of June 30, 2025, total net proceeds from the global offering amounted to RMB 232,927.9 thousand, with the majority allocated to R&D, regulatory filings, and commercialization of products and drug candidates, as well as general corporate and working capital purposes Use of Net Proceeds from Listing | Intended Use | Percentage of Total Proceeds (%) | Total Net Proceeds (RMB thousands) | Amount Utilized (RMB thousands) | Unutilized Amount (RMB thousands) | Expected Timeline | | :--- | :--- | :--- | :--- | :--- | :--- | | R&D, regulatory filings, and commercialization of products and drug candidates | 90 | 209,635.1 | 179,991.0 | 29,644.1 | December 2025 | | (i) Envafolimab® | 55 | 128,110.3 | 128,110.3 | – | N/A | | (ii) Other drug candidates | 25 | 58,232.0 | 47,440.9 | 10,791.1 | December 2025 | | (iii) Construction of Xuzhou production facility and procurement of new equipment | 10 | 23,292.8 | 4,439.8 | 18,853.0 | December 2025 | | General corporate and working capital purposes | 10 | 23,292.8 | 23,292.8 | – | N/A | | Total | 100 | 232,927.9 | 203,283.8 | 29,644.1 | | Use of Net Proceeds from 2023 Placing Net proceeds of approximately RMB 207,372.9 thousand from the 2023 placing were primarily used for clinical trials evaluating Envafolimab® monotherapy, perioperative treatment for non-small cell lung cancer, construction of the Xuzhou production facility, and general corporate working capital Use of Net Proceeds from 2023 Placing | Intended Use | Percentage of Proceeds (%) | Total Net Proceeds (RMB thousands) | Amount Utilized (RMB thousands) | Unutilized Amount (RMB thousands) | Expected Timeline | | :--- | :--- | :--- | :--- | :--- | :--- | | Planned clinical trials evaluating Envafolimab® monotherapy | 50 | 103,686.4 | 3,721.7 | 3,964.8 | December 2025 | | Planned clinical trials for perioperative treatment of non-small cell lung cancer | – | – | 4,804.7 | 91,195.3 | December 2026 | | Construction of Xuzhou production facility buildings and equipment procurement | 40 | 82,949.2 | – | 82,949.2 | December 2025 | | General corporate working capital purposes | 10 | 20,737.3 | 20,737.3 | – | N/A | | Total | 100 | 207,372.9 | 29,263.6 | 178,109.2 | | Dividend Policy The Board does not recommend an interim dividend for the six months ended June 30, 2025, as the company expects to retain all future earnings for business operations and expansion, currently having no dividend policy - The Board does not recommend an interim dividend for the six months ended June 30, 2025[75] - The company expects to retain all future earnings for business operations and expansion, currently having no dividend policy[78] Corporate Governance The company is committed to maintaining high corporate governance standards, having adopted the Corporate Governance Code in Appendix C1 of the Listing Rules, with Dr. Gong Zhaolong serving as both Chairman and CEO, a structure the Board believes ensures consistent leadership with sufficient checks and balances - The company has adopted the Corporate Governance Code as set out in Appendix C1 of the Listing Rules[76] - Dr. Gong Zhaolong serves as both the Chairman of the Board and Chief Executive Officer, a structure the Board believes ensures consistent leadership with sufficient checks and balances[76][77] Standard Securities Trading Code The company has adopted the Standard Code as set out in Appendix C3 of the Listing Rules as the code of conduct for directors' securities transactions, requiring compliance from employees who may possess inside information, with all directors confirming adherence during the reporting period - The company has adopted the Standard Code as set out in Appendix C3 of the Listing Rules as the code of conduct for directors' securities transactions[79] - All directors confirmed compliance with the Standard Code during the reporting period[79] - Employees who may possess unpublished inside information are also required to comply with the Standard Code[80] Interim Results Review The Review Committee has reviewed the Group's unaudited condensed consolidated interim financial information for the six months ended June 30, 2025, confirming its compliance with applicable accounting principles and disclosure requirements, with external auditor Modern Assurance CPA Limited also conducting an independent review and confirming compliance with IAS 34 - The Review Committee has reviewed the interim financial information, confirming compliance with applicable accounting principles, standards, and disclosure requirements[82] - External auditor Modern Assurance CPA Limited has conducted an independent review, confirming that the financial information complies with IAS 34[82] Notes to the Financial Statements This section provides detailed notes to the financial statements, covering company information, accounting policy changes, operating segment data, revenue breakdown, expense details, loss before tax, income tax, dividends, loss per share, and trade receivables/payables Company Information and Basis of Preparation 3D Medicines Inc. was incorporated in the Cayman Islands on January 30, 2018, primarily engaged in pharmaceutical R&D and commercialization, with interim condensed financial information prepared in accordance with IAS 34 and to be read in conjunction with the 2024 annual consolidated financial statements - The company was incorporated in the Cayman Islands on January 30, 2018, primarily engaged in pharmaceutical R&D and commercialization[87] - The interim condensed financial information has been prepared in accordance with IAS 34 "Interim Financial Reporting"[88] Changes in Accounting Policies and Disclosures The accounting policies adopted for the preparation of the interim condensed consolidated financial statements are consistent with those in the 2024 annual consolidated financial statements, with only the initial adoption of new and amended IFRS standards, which had no significant impact on the current period's financial position and performance - Accounting policies are consistent with the 2024 annual consolidated financial statements, with only the initial adoption of new and amended IFRS standards[89] - The new and amended IFRS standards had no significant impact on the Group's financial position and performance for the current and prior years[90] Operating Segment Information The Group is engaged in biopharmaceutical R&D and commercialization, considered a single reportable segment, with all revenue derived from customers in mainland China and almost all non-current assets located in mainland China, thus no geographical information is presented - The Group is engaged in biopharmaceutical R&D and commercialization, considered a single reportable segment[91] - All revenue is derived from customers in mainland China, and almost all non-current assets are located in mainland China[92] Major Customers | Major Customers | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Customer A | 83,622 | 86,014 | | Customer B | 27,450 | 28,748 | | Customer C | N/A* | 24,968 | *For the six months ended June 30, 2025, the amount was less than 10% of the Group's revenue Revenue, Other Income and Net Gains Revenue primarily from product sales totaled RMB 209,167 thousand in H1 2025, while other income and net gains amounted to RMB 17,700 thousand, a year-on-year decrease mainly due to reduced interest income and fair value gains on financial assets at fair value through profit or loss Revenue Source | Revenue Source | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Sales of products | 209,167 | 206,422 | Other Income and Net Gains | Other Income and Net Gains | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Government grants | 4,458 | 1,136 | | Interest income | 3,757 | 6,145 | | Investment income from other investments classified as financial assets at amortized cost | 7,083 | 7,052 | | Subtotal of other income | 15,531 | 14,333 | | Fair value gains on other investments classified as financial assets at fair value through profit or loss | 2,169 | 3,520 | | Subtotal of net gains | 2,169 | 8,104 | | Total | 17,700 | 22,437 | - The decrease in other income and net gains was primarily due to a RMB 2.4 million reduction in interest income and a RMB 1.4 million reduction in fair value gains on other investments classified as financial assets at FVTPL[52] Other Expenses Other expenses primarily comprised donations of RMB 51,192 thousand and net exchange losses of RMB 3,612 thousand, totaling RMB 55,050 thousand Other Expense Items | Other Expense Items | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Donations | 51,192 | 61,134 | | Net exchange losses | 3,612 | – | | Others | 246 | – | | Total | 55,050 | 61,134 | Loss Before Tax The Group's loss before tax was calculated after deducting marketing service fees, royalty fees, cost of sales of inventories, and impairment losses on financial assets, and including fair value gains on other investments classified as financial assets at fair value through profit or loss Loss Before Tax Items | Item | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Marketing service fees | 99,190 | 89,528 | | Royalty fees | 17,637 | 15,619 | | Cost of sales of inventories | 16,260 | 17,473 | | Impairment losses on financial assets | 2,903 | 4,771 | | Fair value gains on other investments classified as financial assets at fair value through profit or loss | (2,169) | (3,520) | Income Tax Income tax expense amounted to RMB 55 thousand, representing over-provision of income tax expense in prior years - Income tax expense was RMB 55 thousand, representing over-provision of income tax expense in prior years[100] Dividends The company neither declared nor paid any dividends for the six months ended June 30, 2025 - The company neither declared nor paid any dividends for the six months ended June 30, 2025[101] Loss Per Share Attributable to Owners of the Parent For the six months ended June 30, 2025, basic and diluted loss per share attributable to owners of the parent was RMB 0.36, an improvement from RMB 0.42 in the prior year period Loss Per Share Attributable to Owners of the Parent | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Loss attributable to owners of the parent used in calculating basic loss per share | (89,350) | (103,509) | | Weighted average number of ordinary shares in issue (thousands) used in calculating basic loss per share | 245,087 | 245,049 | | Loss per share (basic and diluted) (RMB) | (0.36) | (0.42) | - No diluted adjustment was made to the basic loss per share amount due to the anti-dilutive effect of preference shares and restricted share units[102] Trade Receivables As of June 30, 2025, total trade receivables amounted to RMB 95,624 thousand, all within 3 months aging Trade Receivables Aging | Aging | 2025 June 30 (RMB thousands) | 2024 Dec 31 (RMB thousands) | | :--- | :--- | :--- | | Within 3 months | 95,624 | 47,862 | Restricted Bank Balances As of June 30, 2025, restricted bank balances were RMB 168,216 thousand, with all bank account preservation orders lifted post-reporting period following the resolution of the dispute with Qingdao Hainuo - As of June 30, 2025, restricted bank balances amounted to RMB 168,216 thousand[85] - Post-reporting period, the civil lawsuit between the company and Qingdao Hainuo was withdrawn, and all bank account preservation orders were lifted[106][108] Trade Payables As of June 30, 2025, total trade payables amounted to RMB 52,558 thousand, with a significant portion of balances aged over 1 year Trade Payables Aging | Aging | 2025 June 30 (RMB thousands) | 2024 Dec 31 (RMB thousands) | | :--- | :--- | :--- | | Within 3 months | 2,673 | 1,217 | | 3 to 6 months | 706 | 840 | | 6 months to 1 year | 1,341 | 25,891 | | Over 1 year | 47,838 | 23,183 | | Total | 52,558 | 51,131 | Definitions and Glossary This section defines key terms and abbreviations used throughout the interim results announcement, encompassing company products, regulatory bodies, financial metrics, and clinical trial types for enhanced reader understanding Definitions and Glossary This section defines key terms and abbreviations used throughout the interim results announcement, encompassing company products, regulatory bodies, financial metrics, and clinical trial types for enhanced reader understanding - Provides definitions for key terms such as "Envafolimab®," "AML," "FDA," "GMP," "IND," "PD-L1," and "R&D"[110][111][112][113][115][116]