荃信生物(02509) - 2025 - 中期业绩

Company Information and Financial Summary This section provides an overview of the company's identity and key financial performance and position highlights for the six months ended June 30, 2025 Company Overview and Report Statement This announcement by Qyuns Therapeutics Co., Ltd. presents the unaudited interim results for the six months ended June 30, 2025, reviewed by the audit committee and auditor - Company name: Qyuns Therapeutics Co., Ltd. (Jiangsu Qyuns Bio-pharmaceutical Co., Ltd.), stock code: 2509[2] - Reporting period: Unaudited condensed consolidated results for the six months ended June 30, 2025[3] - Review status: The unaudited consolidated financial statements have been reviewed by the company's audit committee and auditor[3] Financial Highlights For the six months ended June 30, 2025, the company's revenue significantly increased to RMB 206.49 million, gross profit substantially improved, and loss for the period narrowed considerably Operating Results for the Six Months Ended June 30 (RMB thousands) | Operating Results | 2025 (Unaudited) | 2024 (Unaudited) | | :---------------- | :----------------- | :----------------- | | Revenue | 206,486 | 44,919 | | Cost of Sales | (28,868) | (7,163) | | Gross Profit | 177,618 | 37,756 | | Net Other Income | 7,162 | 7,402 | | R&D Expenses | (151,394) | (145,226) | | Loss for the Period | (30,933) | (183,139) | | Loss Per Share - Basic and Diluted (RMB) | (0.13) | (0.79) | | Adjusted Loss for the Period | (5,221) | (132,501) | Financial Position as of June 30 (RMB thousands) | Financial Position | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :----------------- | :------------------------ | :------------------------ | | Cash and Cash Equivalents, Time Deposits, and Financial Assets at FVTPL | 558,897 | 556,127 | | Total Non-Current Assets | 453,091 | 367,152 | | Total Current Assets | 679,061 | 616,725 | | Total Non-Current Liabilities | 465,281 | 332,666 | | Total Current Liabilities | 451,042 | 430,161 | | Net Current Assets | 228,019 | 186,564 | | Total Equity | 215,829 | 221,050 | Operating Performance Analysis This section analyzes the company's revenue, cost of sales, R&D expenses, and non-IFRS measures for the six months ended June 30, 2025 Revenue For the six months ended June 30, 2025, the company's revenue significantly increased to RMB 206.49 million, primarily driven by licensing agreement income and CDMO and R&D service income Revenue Composition (RMB millions) | Revenue Source | 2025 H1 | | :----------------------------- | :------ | | Licensing Agreement Income | 180.77 | | CDMO Services and R&D Service Income | 22.00 | | Total Revenue | 206.49 | - Licensing agreement income primarily includes the upfront payment for QX030N overseas licensing, non-cash consideration for approximately 24.88% equity in Caldera Therapeutics, Inc., and the milestone payment for the first patient enrollment in QX004N Phase III[5] Cost of Sales For the six months ended June 30, 2025, cost of sales was RMB 28.87 million, mainly comprising CDMO service costs, QX004N R&D service and QX030N overseas licensing costs, and provisions for inventory write-downs and other contract costs - Cost of sales was RMB 28.87 million, primarily including CDMO service costs, QX004N R&D service and QX030N overseas licensing costs, as well as provisions for inventory write-downs and other contract costs[6] Research and Development Expenses For the six months ended June 30, 2025, R&D expenses increased by 4.25% year-on-year to RMB 151.39 million, mainly due to increased clinical trial costs, partially offset by reduced equity-settled share-based payment amortization R&D Expense Changes (RMB millions) | Metric | 2025 H1 | 2024 H1 | Change | YoY Change | | :----------- | :------ | :------ | :----- | :--------- | | R&D Expenses | 151.39 | 145.23 | +6.16 | +4.25% | - The increase in R&D expenses was primarily due to an increase of RMB 12.04 million in clinical trial expenses as clinical trials progressed, while equity-settled share-based payment amortization decreased by RMB 5.87 million[7] Non-IFRS Measures The company disclosed adjusted loss for the period as a non-IFRS measure, which excludes the impact of equity-settled share-based payment expenses to better reflect core operating performance Non-IFRS Measures (RMB thousands) | Metric | 2025 | 2024 | Change | YoY Change | | :--------------------------- | :--------- | :---------- | :------- | :--------- | | Loss for the Period | (30,933) | (183,139) | 152,206 | (83%) | | Add: Equity-settled share-based payment expenses | 25,712 | 50,638 | (24,926) | (49%) | | Adjusted Loss for the Period | (5,221) | (132,501) | 127,280 | (96%) | - Adjusted loss for the period excludes share-based compensation expenses, which management believes reflects core operating performance and aids in comparing core operating performance across periods and companies[8] Business Overview and Product Pipeline This section provides an overview of the company's focus on autoimmune and allergic diseases, its commercialized product, and the progress of its core product pipeline Company Overview Qyuns Therapeutics, established in 2015, is a biotechnology company focused on biological therapies for autoimmune and allergic diseases, covering dermatology, respiratory, gastroenterology, and rheumatology - The company was established in 2015, focusing on biological therapies for autoimmune and allergic diseases, comprehensively covering dermatology, respiratory, gastroenterology, and rheumatology[9] - The company has one commercialized product, Xilexin® (the first ustekinumab biosimilar in China), and two core products, QX005N and QX002N, are progressing well, with key endpoint data expected by year-end or early next year, or BLA submission[10] - The company has efficiently developed a series of long-acting bispecific antibody products, aiming to address unmet needs, advance product iteration, and pursue global partnerships to accelerate its globalization strategy[11] Core Products and Pipeline Progress The company has one commercialized product, Xilexin®, and multiple core products in late-stage clinical development, including QX005N (IL-4Rα mAb) and QX002N (IL-17A mAb), as well as QX004N (IL-23p19 mAb) and QX008N (TSLP mAb) developed with partners Xilexin® (QX001S) Xilexin® is the first ustekinumab biosimilar approved in China, approved in October 2024, with a new indication for pediatric plaque psoriasis, and over 60,000 vials shipped to Huadong Medicine - Xilexin® was approved by the NMPA in October 2024, becoming the first approved ustekinumab injection biosimilar in China and the company's first commercialized product[22] - On March 3, 2025, the supplementary application for Xilexin®'s new indication for pediatric plaque psoriasis was approved[23] - As of June 30, 2025, over 60,000 vials have been shipped to Huadong Medicine[23] QX005N / HDM3016 QX005N is an IL-4Rα targeted monoclonal antibody with 7 IND approvals, its Phase III clinical trial for PN has completed patient enrollment and was granted Breakthrough Therapy Designation, and its Phase III clinical trial for AD is nearing completion of enrollment - QX005N is an IL-4Rα targeted humanized monoclonal antibody, having obtained 7 IND approvals for indications including AD, PN, CRSwNP, CSU, asthma, and COPD[24] - The Phase III clinical trial for QX005N in PN completed patient enrollment on March 19, 2025, and was included in the Breakthrough Therapy Designation (BTD) list by the CDE in January 2024[25] - The Phase III clinical trial for QX005N in AD is nearing completion of enrollment, and the Phase II clinical trial for CRSwNP was completed in February 2025[25][26] - The company entered into a collaboration agreement with Huadong Medicine to co-develop QX005N, with Phase III clinical trial costs shared 50/50[27] QX002N QX002N is a high-affinity monoclonal antibody targeting IL-17A, its Phase III clinical trial for AS met its primary endpoint in February 2025, with BLA submission planned within the year - QX002N is a monoclonal antibody targeting IL-17A, which plays a key role in the pathogenesis of various autoimmune diseases[28] - Topline results for the QX002N Phase III clinical trial in AS were announced on February 24, 2025, meeting primary and key secondary endpoints, with ASAS40 response rates significantly higher than the placebo group[28] QX004N / HS-20137 QX004N is an IL-23p19 inhibitor for Ps and CD, with Phase I clinical data published and Phase II clinical data showing strong efficacy and good safety in moderate-to-severe plaque psoriasis patients - QX004N is an IL-23p19 inhibitor for the treatment of Ps and CD[29] - In March 2025, Hansoh Pharmaceutical disclosed that Phase II clinical data for QX004N showed strong efficacy and good safety in patients with moderate-to-severe plaque psoriasis[29] - The company entered into an exclusive out-licensing agreement with Hansoh (Shanghai) for the R&D, manufacturing, and commercialization of QX004N in the licensed territories, having received an upfront payment of RMB 75.0 million and Ps Phase III milestone and other payments of RMB 58.0 million[30] QX008N / JKN24011 QX008N is a humanized IgG1 monoclonal antibody targeting TSLP for moderate-to-severe asthma and COPD, with Health & Happiness (H&H) having completed patient enrollment for its COPD China Phase II clinical trial - QX008N is a humanized IgG1 monoclonal antibody targeting TSLP, for the treatment of moderate-to-severe asthma and moderate-to-severe COPD[31] - In January 2024, the company entered into a technology transfer agreement with Health & Happiness (H&H), granting H&H an exclusive license for the development, manufacturing, and commercialization of QX008N in mainland China, Hong Kong, and Macau[32] - Health & Happiness (H&H) is conducting a China Phase II clinical trial for QX008N in COPD and has completed patient enrollment[32] QX013N QX013N is a humanized IgG1 monoclonal antibody targeting c-kit for CSU, the first c-kit targeted biological drug candidate in China, with its IND approval marking the completion of the company's four dermatology indications layout - QX013N is a humanized IgG1 monoclonal antibody targeting c-kit, indicated for the treatment of CSU[33] - QX013N is the first c-kit targeted biological drug candidate in China, and its IND approval marks the completion of the company's comprehensive layout in four dermatological indications (psoriasis, atopic dermatitis, prurigo nodularis, and chronic spontaneous urticaria)[33] - As of the date of this announcement, Phase Ia clinical trials have been completed[33] Bispecific Antibody Products The company is developing a series of long-acting bispecific antibodies for autoimmune diseases, aiming to enhance efficacy, optimize dosing intervals, and reduce costs, with several products planned for IND/CTN submission in 2025-2026 - The company is developing a series of long-acting bispecific antibodies for autoimmune diseases, aiming to enhance clinical efficacy, extend dosing intervals, and optimize convenience of use[34] - QX027N (respiratory and dermatology) is planned for IND submission in China and the US in Q3 2025[34] - QX030N is planned for CTN submission in Australia in Q4 2025, QX031N (respiratory) is planned for IND submission in China and the US in Q4 2025, and QX035N (respiratory and dermatology) is planned for IND submission in China and the US in Q4 2026[34] Pipeline Progress (by Indication) The company's product pipeline covers dermatology, respiratory, gastroenterology, and rheumatology, with multiple products ranging from preclinical to Phase III and commercialized stages - The company's product pipeline covers multiple indications including dermatology (Ps, PN, AD, CSU), respiratory (Asthma, COPD, CRSwNP), gastroenterology (CD), and rheumatology (AS)[15][17] - The commercialized product is Xilexin®, while core products QX005N and QX002N are in Phase III clinical trials, and QX004N and QX008N are also in Phase III or Phase II clinical trials[15][17] Expected Progress of Key Products The company anticipates several key clinical milestones and BLA submissions/approvals from 2025 to 2027, including key endpoint data readouts, BLA submissions, and approvals for QX005N-PN, QX005N-AD, and QX002N - In Q3 2025, QX005N-PN Phase III key endpoint data readout; QX027N planned for IND submission in China and the US[19] - In Q4 2025, QX005N-AD Phase III key endpoint data readout; QX005N-PN planned for BLA submission; QX030N planned for CTN submission in Australia; QX031N planned for IND submission in China and the US[19] - In 2026, QX005N-AD planned for BLA submission; QX002N planned for BLA submission; QX005N-PN and QX005N-AD expected for BLA approval[19] - In 2027, QX002N expected for BLA approval[19] R&D Strategy and Capabilities This section outlines the company's R&D achievements, integrated antibody drug development platform, and strategic focus areas for future product development R&D Achievements and Platforms R&D is the cornerstone of the company's sustained success, with one monoclonal antibody drug launched, three innovative monoclonal antibodies in Phase III clinical trials, and one innovative bispecific antibody licensed overseas - The company has one monoclonal antibody drug approved for launch, three innovative monoclonal antibody drugs in Phase III clinical research, and one innovative bispecific antibody drug licensed overseas[36] - The company has established an integrated antibody drug R&D platform, including high-throughput monoclonal antibody discovery, innovative bispecific antibody design and development, a comprehensive CMC development system, and a translational medicine research platform[36] R&D Focus Areas The company's R&D focuses on respiratory diseases, inflammatory bowel disease (IBD), and dermatological diseases, aiming to develop superior long-term treatments, improve clinical remission rates, and explore new strategies for rapid symptom and lesion relief - Respiratory diseases: Develop superior long-term treatment products aimed at delaying, halting, or even reversing disease progression and maintaining long-term efficacy[37] - Inflammatory Bowel Disease (IBD): Develop innovative products that significantly improve clinical and endoscopic remission rates, addressing the unmet needs of patients treated with biologics[37] - Dermatological diseases (AD and CSU): Explore new treatment strategies to achieve rapid symptom and lesion relief, reduce recurrence risk, significantly extend recurrence-free periods, and develop next-generation drugs effective for refractory patients[38] - Bispecific antibody product development goals: Enhance efficacy, optimize dosing intervals, strengthen compliance, and reduce medication costs[38] R&D Expense Details For the six months ended June 30, 2025, the company's total R&D costs were RMB 151.39 million, with third-party contract costs accounting for the largest proportion, while staff costs and depreciation and amortization decreased R&D Cost Details (RMB thousands) | Item | 2025 | 2024 | | :------------------- | :---------- | :---------- | | Staff Costs | 26,826 | 40,683 | | Depreciation and Amortization | 4,987 | 10,921 | | Third-party Contract Costs | 106,209 | 79,636 | | Raw Materials and Consumables | 6,130 | 6,352 | | Others | 7,242 | 7,634 | | Total | 151,394 | 145,226 | - Third-party contract costs, a major component of R&D expenses, increased from RMB 79.64 million in 2024 to RMB 106.21 million in 2025[41] - Staff costs and depreciation and amortization both decreased in the first half of 2025[41] Manufacturing and Commercialization This section details the company's production facilities, manufacturing capabilities, and strategic approach to commercializing its pharmaceutical products Production Facilities and Capabilities The company's production facilities are built in strict accordance with cGMP standards, have obtained a drug manufacturing license, and passed NMPA's GMP compliance inspection - Production facilities are built in strict accordance with China, US, and EU cGMP standards and have obtained a drug manufacturing license[42] - In November 2024, the Saifu Si facility passed the NMPA's GMP compliance inspection for Xilexin® drug substance and drug product manufacturing[42] - The production base has a drug substance production line with an annual capacity of approximately 300kg of therapeutic antibodies, and two drug product production lines (vial production line capacity of 18,000 vials/hour, pre-filled syringe production line capacity of 9,000 syringes/hour)[42] Commercialization Strategy The company plans to leverage strategic partners' physician resources and networks to establish connections with drug sales and distribution chain participants, laying the groundwork for the commercial launch of its candidate drugs - The company will continue to leverage strategic partners' physician resources and networks to establish connections with participants in the drug sales and distribution chain, laying the foundation for the commercial launch of its candidate drugs[43] - In the future, the company plans to start with indications where the patient population is relatively limited and concentrated in a few key hospitals, building a relatively small, specialized internal commercialization team for specific indications[43] Intellectual Property As of June 30, 2025, the company holds 50 patents in China and 16 overseas patents, with 47 patent applications pending, and has registered 94 trademarks and 21 domain names - As of June 30, 2025, the company holds 50 patents in China (40 invention patents, 10 utility model patents) and 16 overseas patents[44] - As of the same date, the company has 47 patent applications pending approval in China and overseas[44] - Core product QX002N has 9 registered patents and 1 pending patent application, while QX005N has 8 registered patents and 1 pending patent application[44] - As of June 30, 2025, the company has registered 94 trademarks in China and Hong Kong and owns the registration of 21 domain names in China[44] Employees and Remuneration As of June 30, 2025, the Group had 337 employees, all located in China, with remuneration packages including salaries, bonuses, and equity incentives determined by qualifications, experience, position, and performance - As of June 30, 2025, the Group had 337 employees, all located in China[45] - Employee remuneration packages include salaries, bonuses, and equity incentives, determined based on qualifications, industry experience, position, and performance[45] - The company has adopted an employee share incentive scheme, and there were no significant labor disputes or recruitment difficulties during the reporting period[45] Future Outlook The company plans to continuously stabilize its foundation, aiming for at least 5 products to be approved and achieve substantial sales by 2030, while strategically expanding its bispecific antibody pipeline and global partnerships - Continuously stabilize the foundation, striving for at least 5 products to be approved and achieve substantial sales by 2030[47] - Advance the R&D of bispecific antibody candidates and strategically expand the pipeline to meet significant treatment needs in respiratory, IBD, and dermatological fields[47] - Continuously optimize the CMC quality management system, improve production efficiency, and enhance capacity utilization[47] - Engage in commercialization collaborations with renowned pharmaceutical companies, resolutely execute the globalization strategy, and further expand overseas partnerships[47] - Continuously recruit and develop talent[47] Financial Position Analysis This section provides a detailed analysis of the company's non-current assets, net current assets, inventories, receivables, payables, and contract liabilities as of June 30, 2025 Non-Current Assets As of June 30, 2025, non-current assets increased to RMB 453.09 million, primarily due to the acquisition of approximately 24.88% equity in Caldera under the QX030N overseas licensing agreement Non-Current Asset Changes (RMB millions) | Metric | June 30, 2025 | December 31, 2024 | Change | | :--------------- | :------------ | :---------------- | :----- | | Non-Current Assets | 453.09 | 367.15 | +85.94 | - Primarily due to the acquisition of approximately 24.88% equity in Caldera under the QX030N overseas licensing agreement, with an assessed fair value of approximately RMB 96.79 million[87] Net Current Assets As of June 30, 2025, net current assets increased to RMB 228.02 million, mainly driven by net cash inflows from non-current interest-bearing bank borrowings and upfront and milestone payments from QX030N and QX008N out-licensing transactions Net Current Asset Changes (RMB millions) | Metric | June 30, 2025 | December 31, 2024 | Change | | :--------------- | :------------ | :---------------- | :----- | | Net Current Assets | 228.02 | 186.56 | +41.46 | - Primarily due to a net increase in cash inflow of RMB 132.65 million from non-current interest-bearing bank borrowings, and upfront and milestone payments of RMB 74.04 million received from QX030N and QX008N out-licensing transactions[88] Inventories and Other Contract Costs As of June 30, 2025, inventories and other contract costs increased to RMB 32.80 million, mainly due to increased capitalized contract costs driven by the growth of the CDMO business Inventories and Other Contract Costs Changes (RMB millions) | Metric | June 30, 2025 | December 31, 2024 | Change | | :--------------------------- | :------------ | :---------------- | :----- | | Inventories and Other Contract Costs | 32.80 | 8.77 | +24.03 | - Primarily comprises Xilexin® inventories, raw materials, and contract costs for external CDMO services, with the increase mainly due to the growth of the developing CDMO business[89] Trade and Other Receivables As of June 30, 2025, trade and other receivables increased to RMB 87.36 million, primarily attributable to an increase of RMB 58.00 million in receivables from the QX004N out-licensing project Trade and Other Receivables Changes (RMB millions) | Metric | June 30, 2025 | December 31, 2024 | Change | | :------------------------- | :------------ | :---------------- | :----- | | Trade and Other Receivables | 87.36 | 51.82 | +35.54 | - Primarily attributable to receivables of RMB 58.00 million from the QX004N out-licensing project as of the end of June 2025[90] Trade and Other Payables As of June 30, 2025, trade and other payables increased to RMB 241.79 million, mainly due to an increase of approximately RMB 30.00 million in clinical trial payables as clinical trials progressed Trade and Other Payables Changes (RMB millions) | Metric | June 30, 2025 | December 31, 2024 | Change | | :----------------------- | :------------ | :---------------- | :----- | | Trade and Other Payables | 241.79 | 208.79 | +33.00 | - Primarily due to an increase of approximately RMB 30.00 million in clinical trial payables as clinical trials progressed[91] Contract Liabilities As of June 30, 2025, contract liabilities were RMB 21.50 million, mainly representing upfront payments for the QX030N overseas licensing project that had not yet met revenue recognition conditions Contract Liabilities Changes (RMB millions) | Metric | June 30, 2025 | December 31, 2024 | Change | | :----------------- | :------------ | :---------------- | :----- | | Contract Liabilities | 21.50 | 9.36 | +12.14 | - Primarily represents upfront payments for the QX030N overseas licensing project that had not yet met revenue recognition conditions, expected to be recognized as revenue upon fulfillment of delivery conditions[92] Contingent Liabilities As of June 30, 2025, the Group had no material contingent liabilities - As of June 30, 2025, the Group had no material contingent liabilities[93] Liquidity and Capital Resources This section details the company's sources of funding, debt structure, key financial ratios, and asset pledges, providing insight into its financial stability and capital management Sources of Funding The company primarily relies on shareholder contributions, equity financing, upfront and milestone payments from out-licensing transactions, CDMO service income, and bank and other borrowings for its liquidity - Primary sources of liquidity include shareholder contributions, equity financing, upfront and milestone payments from out-licensing transactions, CDMO service income, and bank and other borrowings[94] - Future cash is expected from profit sharing and product supply of Xilexin®, debt financing, refinancing, milestone payments from QX030N, QX008N, and QX004N out-licensing transactions, and cost sharing for co-development of QX005N with Huadong Medicine[94] - As of June 30, 2025, the company had unutilized credit facilities of RMB 180.73 million available for working capital purposes[95] Debt Structure As of June 30, 2025, the company's total interest-bearing borrowings were RMB 634.12 million, primarily comprising secured and unsecured bank loans, with an optimized loan structure showing a significant increase in the proportion of 2-3 year working capital loans Total Interest-Bearing Borrowings (RMB millions) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------- | :------------ | :---------------- | | Total Interest-Bearing Borrowings | 634.12 | 525.70 | - Primarily includes secured bank loans for production facility construction and unsecured bank loans supporting operations[96] - As of June 30, 2025, the balance of 2-3 year working capital loans accounted for 74.9% of the total working capital loan balance (December 31, 2024: 39.1%), indicating an optimized loan structure[94] Key Financial Ratios As of June 30, 2025, the company's current ratio increased to 1.5, and the debt-to-asset ratio rose to approximately 80.9%, primarily due to increased utilization of working capital loans during the period Current Ratio As of June 30, 2025, the current ratio increased from 1.4 as of December 31, 2024, to 1.5, mainly due to an increase in receivables related to out-licensing agreements Current Ratio Changes | Metric | June 30, 2025 | December 31, 2024 | | :---------- | :------------ | :---------------- | | Current Ratio | 1.5 | 1.4 | - The increase in current ratio was primarily due to an increase of RMB 35.49 million in receivables related to out-licensing agreements as of June 30, 2025, compared to the end of 2024[97] Debt-to-Asset Ratio As of June 30, 2025, the debt-to-asset ratio was approximately 80.9%, an increase from 77.5% as of December 31, 2024, mainly due to increased utilization of working capital loans during the period Debt-to-Asset Ratio Changes | Metric | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Debt-to-Asset Ratio | 80.9% | 77.5% | - The increase in the debt-to-asset ratio was primarily due to increased utilization of working capital loans during the period[98] Pledge of Assets The Group's land use rights and production facilities in Taizhou were pledged as collateral for secured long-term loans in July 2024 - The Group's land use rights and production facilities in Taizhou were pledged as collateral for the 2024 secured long-term loans in July 2024[99] Risk Management This section outlines the various market and financial risks faced by the Group, including interest rate risk, credit risk, liquidity risk, and foreign exchange risk, and the strategies employed to manage them Market Risk The Group is exposed to various market and other financial risks, including cash flow and fair value interest rate risk, credit risk, liquidity risk, and currency risk - The Group is exposed to cash flow and fair value interest rate risk, credit risk, liquidity risk, and currency risk[100] Credit Risk Credit risk primarily arises from trade and other receivables, but credit risk for cash and cash equivalents and wealth management products is limited due to reputable bank or financial institution counterparties - Credit risk primarily arises from trade and other receivables[101] - Credit risk for cash and cash equivalents and wealth management products is limited, as counterparties are reputable banks or financial institutions[101] - As of June 30, 2025, approximately 99.95% of total trade receivables were from the top five debtors[101] Liquidity Risk The company manages liquidity risk by regularly monitoring liquidity needs, complying with loan covenants, and maintaining sufficient cash reserves, readily marketable securities, and committed credit facilities from major financial institutions - The company's policy is to regularly monitor liquidity needs and comply with loan covenants, ensuring sufficient cash reserves and readily marketable securities are maintained[102] - Sufficient committed credit facilities are obtained from major financial institutions to meet short-term and long-term liquidity needs[102] Interest Rate Risk Interest rate risk primarily stems from long-term borrowings, with floating-rate borrowings exposed to cash flow interest rate risk and fixed-rate borrowings to fair value interest rate risk - Interest rate risk primarily arises from long-term borrowings, with floating-rate borrowings exposed to cash flow interest rate risk and fixed-rate borrowings to fair value interest rate risk[103] - The company regularly reviews its interest rate risk management strategy based on prevailing market conditions and did not use any interest rate swaps to hedge interest rate risk during the reporting period[103] Foreign Exchange Risk Foreign exchange risk primarily arises from cash balances denominated in foreign currencies (USD and HKD) other than bank deposits - Foreign exchange risk primarily arises from cash balances denominated in foreign currencies (USD and HKD) other than bank deposits[104] - The Group has not undertaken any hedging transactions to manage potential foreign exchange fluctuations[104] Material Investments, Acquisitions, and Disposals This section details the company's significant investment activities, including an equity investment in Caldera Therapeutics and investments in wealth management products Equity Investment in Caldera Therapeutics On April 23, 2025, the company entered into a global exclusive licensing agreement for QX030N with Caldera Therapeutics, Inc. and acquired approximately 24.88% equity in Caldera - On April 23, 2025, the company entered into a global exclusive licensing agreement for QX030N with Caldera Therapeutics, Inc.[106] - Pursuant to the licensing agreement, the company received a non-refundable upfront payment of USD 10,000,000 and approximately 24.88% equity in Caldera[106] - As of June 30, 2025, the fair market value of Caldera's equity was assessed at USD 13,521,314 (approximately RMB 96,793,678.40), representing over 5% of the company's total assets[107] Wealth Management Product Investments During the reporting period, to effectively utilize idle funds, the company subscribed to and held low-risk principal-protected floating-rate wealth management products managed by national or regional commercial banks, totaling RMB 140 million - During the reporting period, the company subscribed to and held various wealth management products (primarily principal-protected floating-rate) managed by national commercial banks or local branches of regional commercial banks in Jiangsu Province[108] Material Wealth Management Product Investments (as of June 30, 2025) | Product Name | Subscribed Principal (RMB millions) | Product Type | Product Risk Level | | :--------------------------- | :-------------------------------- | :--------------------- | :----------------- | | Liduo Duo Company Stable Profit 25JG5700 | 60 | Principal-protected floating-rate | Low Risk | | Liduo Duo Company Stable Profit 25JG3094 | 80 | Principal-protected floating-rate | Low Risk | - The company's investment strategy is relatively cautious, investing only in low-risk wealth management products offered by major and reputable commercial banks, not for trading or speculative purposes in stocks[109] Future Plans and Capital Assets Except as disclosed in the prospectus and this announcement, as of the date of this announcement, the Group has no other material investment and capital asset plans - Except as disclosed in the "Future Plans and Use of Proceeds" section of the prospectus and this announcement, as of the date of this announcement, the Group has no material investment and capital asset plans[112] Subsidiaries, Associates, and Joint Ventures For the six months ended June 30, 2025, the Group did not undertake any material acquisitions or disposals of subsidiaries, associates, and joint ventures - For the six months ended June 30, 2025, the Group did not undertake any material acquisitions or disposals of subsidiaries, associates, and joint ventures[113] Other Information This section covers various corporate governance and operational updates, including changes in directors' information, H share full circulation, amendments to articles of association, and the use of global offering proceeds Changes in Directors' and Supervisors' Information During the reporting period, there were no changes in the information of the company's directors and supervisors required to be disclosed under Rule 13.51B(1) of the Listing Rules - During the reporting period, there were no changes in the information of the company's directors and supervisors required to be disclosed under Rule 13.51B(1) of the Listing Rules[114] H Share Full Circulation The company completed the conversion and listing of 17,322,400 non-listed shares into H shares on March 27, 2025, which commenced trading on the Stock Exchange on March 28, 2025 - The company completed the conversion of 17,322,400 non-listed shares into H shares and their listing on March 27, 2025[115] - The converted H shares commenced trading on the Stock Exchange at 9:00 a.m. on March 28, 2025[115] Amendments to Articles of Association The company proposed amendments to its Articles of Association on April 30, 2025, which were approved by a special resolution at the Annual General Meeting held on June 20, 2025 - The company proposed amendments to its Articles of Association on April 30, 2025, to comply with relevant laws and regulations[117] - The amendments to the Articles were approved by a special resolution at the company's Annual General Meeting held on June 20, 2025[118] Purchase, Sale, or Redemption of Company Shares During the reporting period and up to the date of this announcement, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities, nor did they hold any treasury shares - During the reporting period and up to the date of this announcement, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities[119] - As of the date of this announcement, the company did not hold any treasury shares[120] Standard Securities Dealing Code for Directors The company has adopted the Standard Code as set out in Appendix C3 of the Listing Rules and confirmed compliance by all directors and supervisors during the reporting period - The company has adopted the Standard Code as set out in Appendix C3 of the Listing Rules as a code of conduct for directors and supervisors dealing in the company's securities[121] - All directors and supervisors confirmed compliance with the Standard Code throughout the reporting period, and the company found no instances of non-compliance[121] Remuneration Policy The remuneration of directors, supervisors, and senior management is determined by the Board with reference to their duties, experience, individual performance, and time commitment, and can be adjusted based on the recommendations of the Remuneration and Appraisal Committee - The remuneration of directors, supervisors, and senior management is determined by the Board with reference to their respective duties, experience, individual performance, and time commitment[122] - The Remuneration and Appraisal Committee is responsible for reviewing the company's remuneration policy and the remuneration structure for directors, supervisors, and senior management[122] Corporate Governance Practices The company is committed to achieving high standards of corporate governance and has adopted the principles and code provisions of the Corporate Governance Code set out in Appendix C1 of the Listing Rules - The company has adopted the principles and code provisions of the Corporate Governance Code set out in Appendix C1 of the Listing Rules as the basis for its corporate governance practices[123] - Mr. Qiu serves as both the Chairman of the Board and the General Manager (equivalent to CEO), which deviates from code provision C.2.1, but the Board believes this arrangement ensures consistent leadership and more effective and efficient overall strategic planning for the company[124] - The Board comprises experienced individuals with diverse backgrounds, including two non-executive directors and three independent non-executive directors, and Mr. Feng Zhiwei has been designated as the Lead Independent Non-Executive Director effective August 15, 2025[124] Interim Dividend The Board has resolved not to declare an interim dividend for the six months ended June 30, 2025 - The Board has resolved not to declare an interim dividend for the six months ended June 30, 2025[127] Use of Proceeds from Global Offering The company's H shares were listed on March 20, 2024, with net proceeds from the global offering of approximately HKD 163.3 million - The company's H shares were listed on the Main Board of the Stock Exchange on March 20, 2024, with net proceeds from the global offering of approximately HKD 163.3 million[128] - As of June 30, 2025, the company had utilized HKD 36.3 million of the proceeds from the global offering[128] - The company intends to use the net proceeds in the same manner and proportions as set out in the "Future Plans and Use of Proceeds" section of the prospectus[128] Events After the Reporting Period On July 4, 2025, the company entered into two subscription agreements with SPD Bank to subscribe for wealth management products with a principal amount of RMB 120 million - On July 4, 2025, the company entered into two subscription agreements with SPD Bank to subscribe for wealth management products with a principal amount of RMB 120 million, maturing on October 9, 2025[129] - The Board has designated Independent Non-Executive Director Mr. Feng Zhiwei to serve as the Lead Independent Non-Executive Director effective August 15, 2025[130] Audit Committee and Review of Financial Statements The Audit Committee has reviewed the unaudited interim financial information for the six months ended June 30, 2025, confirming compliance with relevant accounting standards, rules, and regulations - The Audit Committee has reviewed the financial information for the six months ended June 30, 2025, contained in this announcement and is satisfied that it has been prepared in accordance with applicable accounting standards[133] - The Audit Committee comprises three members, with Mr. Feng Zhiwei serving as the Chairman of the Audit Committee[132] - External auditor KPMG has reviewed the unaudited condensed consolidated financial statements in accordance with Hong Kong Standard on Review Engagements 2410 issued by the Hong Kong Institute of Certified Public Accountants[133] Publication of Interim Results and Interim Report This results announcement has been published on the Stock Exchange website and the company's website, with the interim report for the six months ended June 30, 2025, to be published in due course - This results announcement is published on the Stock Exchange website (http://www.hkexnews.hk) and the company's website (www.qyuns.net)[134](index=134&type=chunk) - The interim report for the six months ended June 30, 2025 (containing all relevant information required by the Listing Rules) will be published in due course[134] Consolidated Financial Statements This section presents the company's consolidated statement of profit or loss and other comprehensive income, consolidated statement of financial position, and condensed consolidated statement of cash flows for the reporting period Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, the company's revenue significantly grew to RMB 206.49 million, with gross profit of RMB 177.62 million, operating loss narrowed significantly to RMB 18.59 million, and loss for the period was RMB 30.93 million Summary of Consolidated Statement of Profit or Loss and Other Comprehensive Income (RMB thousands) | Item | 2025 (Unaudited) | 2024 (Unaudited) | | :----------------------- | :----------------- | :----------------- | | Revenue | 206,486 | 44,919 | | Cost of Sales | (28,868) | (7,163) | | Gross Profit | 177,618 | 37,756 | | Other Income | 7,162 | 7,402 | | R&D Expenses | (151,394) | (145,226) | | Operating Loss | (18,585) | (169,234) | | Loss for the Period | (30,933) | (183,139) | | Loss Per Share - Basic and Diluted (RMB) | (0.13) | (0.79) | - Revenue increased by 359.7% year-on-year, and gross profit increased by 370.4% year-on-year[48] - Loss for the period significantly narrowed by 83.1% year-on-year[48] Consolidated Statement of Financial Position As of June 30, 2025, the company's total assets were RMB 1,132.15 million, with non-current assets of RMB 453.09 million and current assets of RMB 679.06 million Summary of Consolidated Statement of Financial Position (RMB thousands) | Item | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :----------------------- | :------------------------ | :------------------------ | | Total Non-Current Assets | 453,091 | 367,152 | | Total Current Assets | 679,061 | 616,725 | | Total Current Liabilities | 451,042 | 430,161 | | Total Non-Current Liabilities | 465,281 | 332,666 | | Total Equity | 215,829 | 221,050 | - The increase in non-current assets was primarily due to equity investments designated at fair value through other comprehensive income (Caldera equity) of RMB 96.79 million[49] - Cash and cash equivalents increased to RMB 499.32 million, and time deposits increased to RMB 39.50 million[49] Condensed Consolidated Statement of Cash Flows For the six months ended June 30, 2025, net cash used in operating activities was RMB (91.76) million, net cash from investing activities was RMB 137.73 million, and net cash from financing activities was RMB 95.81 million Summary of Condensed Consolidated Statement of Cash Flows (RMB thousands) | Item | 2025 (Unaudited) | 2024 (Unaudited) | | :--------------------------- | :----------------- | :----------------- | | Net Cash Used in Operating Activities | (91,764) | (66,846) | | Net Cash From Investing Activities | 137,730 | 3,389 | | Net Cash From Financing Activities | 95,814 | 314,451 | | Net Increase in Cash and Cash Equivalents | 141,780 | 250,994 | | Cash and Cash Equivalents at End of Period | 499,324 | 468,436 | - Net cash from investing activities significantly increased, primarily reflecting cash inflows from out-licensing transactions[51] - Net cash from financing activities decreased year-on-year but remained positive, indicating continued financing support for the company[51] Notes to the Financial Statements This section provides detailed notes to the interim financial report, covering the basis of preparation, changes in accounting policies, revenue classification, other income, loss before tax, income tax, and per-share loss Basis of Preparation and Changes in Accounting Policies This interim financial report is prepared in accordance with the Listing Rules of the Hong Kong Stock Exchange and International Accounting Standard 34, and has been authorized for issue - This interim financial report is prepared in accordance with the Listing Rules of the Hong Kong Stock Exchange and International Accounting Standard 34[52] - The interim financial report is unaudited but has been reviewed by KPMG in accordance with Hong Kong Standard on Review Engagements 2410[53] - The Group has applied International Accounting Standard 21 (Revised) in this accounting period, but it has no material impact on this interim report[55] Revenue Classification and Geographical Information The Group's revenue primarily derives from intellectual property licensing, R&D services, and product sales, with revenue from customer contracts totaling RMB 206.49 million for the six months ended June 30, 2025 Revenue Classification (RMB thousands) | Revenue Type | 2025 | 2024 | | :--------------------------------- | :------ | :----- | | Licensing Agreement Income | 180,770 | 44,919 | | Income from Providing R&D and Other Services | 22,000 | – | | Product Sales | 3,716 | – | | Total | 206,486 | 44,919 | Revenue by Geographical Location (RMB thousands) | Region | 2025 | 2024 | | :----- | :------ | :----- | | China | 54,017 | 44,919 | | USA | 152,469 | – | | Total | 206,486 | 44,919 | - For resource allocation and performance assessment, the Group's management focuses on overall operating performance and does not provide separate operating segment information[60] Other Income and Loss Before Tax For the six months ended June 30, 2025, other income was RMB 7.16 million, primarily comprising bank deposit interest income and net realized and unrealized gains on financial assets at fair value through profit or loss Other Income (RMB thousands) | Item | 2025 | 2024 | | :----------------------------------------- | :---- | :---- | | Government Grants | 1,575 | 5,539 | | Bank Deposit Interest Income | 4,030 | 3,521 | | Net Realized and Unrealized Gains on Financial Assets at FVTPL | 1,557 | 2,188 | | Others | – | (3,846) | | Total | 7,162 | 7,402 | Finance Costs (RMB thousands) | Item | 2025 | 2024 | | :------------------- | :----- | :----- | | Interest on Interest-Bearing Borrowings | 10,507 | 13,912 | | Interest on Lease Liabilities | 30 | 30 | | Other Finance Costs | 1,848 | – | | Total | 12,385 | 13,942 | - Loss before tax was RMB (30,970) thousand, a significant reduction compared to the same period last year[48] Income Tax and Loss Per Share For the six months ended June 30, 2025, income tax was RMB (37) thousand, and basic and diluted loss per share was RMB (0.13), a significant decrease from the prior year Income Tax (RMB thousands) | Item | 2025 | 2024 | | :---------- | :--- | :--- | | Deferred Tax | (37) | (37) | | Total | (37) | (37) | - Basic loss per share is calculated by dividing the loss attributable to ordinary equity holders of the company of RMB 28,333,000 by the weighted average number of ordinary shares outstanding during the period of 222,072,000 shares[69] - Pursuant to the PRC Enterprise Income Tax Law, eligible R&D expenses incurred can be super-deducted by 100% from taxable income for the year ended December 31, 2025[68] Property, Plant and Equipment For the six months ended June 30, 2025, the Group acquired plant and equipment with a cost of RMB 2,274,000 - For the six months ended June 30, 2025, the Group acquired plant and equipment with a cost of RMB 2,274,000[70] - Pursuant to borrowing arrangements, the Group's land use rights and production facilities in Taizhou were pledged as collateral in August 2023, with a carrying amount of RMB 222,560,000 as of June 30, 2025[70] Equity Investments Designated at Fair Value Through Other Comprehensive Income As of June 30, 2025, the company recognized new unlisted equity investments of RMB 96,794 thousand, representing approximately 24.88% equity in Caldera Therapeutics, Inc. received under the QX030N licensing agreement and measured at fair value Equity Investments (RMB thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Unlisted Equity Investments (at fair value) | 96,794 | – | - This investment represents approximately 24.88% equity in Caldera Therapeutics, Inc. received under the QX030N licensing agreement and is designated at fair value through other comprehensive income as it is held for strategic purposes[71] Inventories and Other Contract Costs As of June 30, 2025, total inventories and other contract costs amounted to RMB 32,800 thousand, including inventories of RMB 6,483 thousand and other contract costs for fulfilling existing contracts of RMB 26,317 thousand Inventories and Other Contract Costs (RMB thousands) | Item | June 30, 2025 | | :--------------------------------- | :------------ | | Inventories | 6,483 | | Other Contract Costs for Fulfilling Existing Contracts | 26,317 | | Total | 32,800 | - For the six months ended June 30, 2025, RMB 1,948 thousand was recognized as a reduction in inventories and other contract costs, charged to "Cost of Sales"[72] Trade and Other Receivables As of June 30, 2025, total trade and other receivables amounted to RMB 87,364 thousand, of which trade receivables were RMB 67,632 thousand Trade and Other Receivables (RMB thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------- | :------------ | :---------------- | | Trade Receivables | 67,632 | 26,281 | | Prepayments | 18,196 | 24,520 | | Deposits | 563 | 424 | | Interest Receivable | 762 | 491 | | Other Receivables | 211 | 108 | | Total | 87,364 | 51,824 | - Trade receivables are generally due within 60 to 180 days from the invoice date[73] Financial Assets at Fair Value Through Profit or Loss As of June 30, 2025, financial assets at fair value through profit or loss amounted to RMB 20,073 thousand, primarily consisting of investments in wealth management products purchased from Bank of China Financial Assets at Fair Value Through Profit or Loss (RMB thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Wealth Management Products | 20,073 | 195,439 | - These financial assets include investments in wealth management products purchased from Bank of China[74] Time Deposits and Cash and Cash Equivalents As of June 30, 2025, time deposits amounted to RMB 39,500 thousand, and cash and cash equivalents amounted to RMB 499,324 thousand, totaling RMB 538,824 thousand Time Deposits and Cash and Cash Equivalents (RMB thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Time Deposits with Original Maturity Over Three Months | 39,500 | – | | Bank Balances | 291,706 | 197,110 | | Time Deposits with Original Maturity Within Three Months | 207,618 | 163,578 | | Cash and Cash Equivalents | 499,324 | 360,688 | Trade and Other Payables As of June 30, 2025, total trade and other payables amounted to RMB 241,790 thousand, of which trade payables were RMB 126,577 thousand Trade and Other Payables (RMB thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Trade Payables | 126,577 | 110,885 | | Accrued Salaries | 26,540 | 33,373 | | Payables for Purchase of Property, Plant and Equipment | 5,089 | 6,758 | | Accrued Listing Expenses | 478 | 3,290 | | Other Payables and Accrued Expenses | 83,106 | 54,488 | | Total | 241,790 | 208,794 | - Other payables and accrued expenses include RMB 24,377 thousand of QX005N clinical development expenses paid by Huadong Medicine on behalf of the company, recognized as a financial liability of the company under the QX005N agreement[76] Interest-Bearing Borrowings As of June 30, 2025, total interest-bearing borrowings amounted to RMB 634,118 thousand, including short-term bank loans, and current and non-current portions of long-term bank loans Interest-Bearing Borrowings (RMB thousands) | Item | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | Unsecured Short-Term Bank Loans | 104,583 | 179,483 | | Current Portion of Unsecured Long-Term Bank Loans | 53,954 | 3,291 | | Current Portion of Secured Long-Term Bank Loans | 27,808 | 27,808 | | Within 1 Year or On Demand | 186,345 | 210,582 | | Unsecured Long-Term Bank Loans | 258,068 | 111,700 | | Secured Long-Term Bank Loans | 189,705 | 203,420 | | Non-Current | 447,773 | 315,120 | | Total | 634,118 | 525,702 | - Unsecured short-term and long-term bank loans bear