映恩生物(09606) - 2025 - 中期业绩

Financial Highlights Revenue grew, but loss expanded significantly due to financial liability fair value changes; adjusted profit and cash balances increased Financial Highlights for the Six Months Ended June 30, 2025 | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | Period-on-Period Change | | :--- | :--- | :--- | :--- | | Revenue | 1,228,934 | 999,826 | 22.9% | | Research and Development Expenses | (349,387) | (377,579) | -7.5% | | Loss for the Period | (2,073,865) | (293,438) | 606.7% | | Adjusted Profit for the Period | 145,920 | 127,831 | 14.2% | | Balance Sheet (Period-end): | | | | | Cash and Bank Balances | 3,746,792 | 1,435,827 | 161.0% | | Total Equity / (Loss) | 2,912,761 | (2,021,899) | 244.1% | - Loss for the period significantly increased by 606.7%, primarily due to fair value changes of financial liabilities measured at fair value through profit or loss, mainly from fair value adjustments of pre-global offering preferred shares[4][7] Business Summary The company achieved significant pipeline and operational progress in H1 2025, enrolling over 2,600 patients, half from outside China Pipeline Progress Core and key ADC candidates achieved significant clinical milestones, including FDA Fast Track designation and positive ASCO/AACR data - Next-generation HER3-targeting ADC DB-1310 received FDA Fast Track designation for specific advanced non-small cell lung cancer patients[8] - First patient dosed in the Phase 1 clinical study of novel EGFR/HER3 BsADC DB-1418/AVZO-1418, with FDA IND approval obtained in June 2025[8] - At the 2025 ASCO Annual Meeting, DB-1310 (HER3 ADC) showed an unconfirmed ORR of 43.5% and DCR of 91.3% in EGFRm NSCLC patients; DB-1311/BNT324 (B7-H3 ADC) confirmed ORR of 30.8% and DCR of 90.4% in CRPC patients[8] - At the 2025 AACR Annual Meeting, initial clinical data for BNT327 (PD-L1xVEGF bsAb) in combination with DB-1305 showed controllable safety and early signs of anti-tumor activity[8] Collaboration with BioNTech on ADC and Immunotherapy Combination Treatments The company collaborates with BioNTech SE to explore combination therapies for solid tumors, initiating multiple clinical trials - First patient dosed in the Phase 1/2 clinical trial of DB-1303/BNT323 combined with BNT327 for advanced/metastatic breast cancer[11] - First patient dosed in the Phase 1/2 clinical trial of DB-1311/BNT324 combined with BNT327 for advanced lung cancer[11] - First patient dosed in the Phase 2 clinical trial of DB-1311/BNT324 combined with BNT327 or DB-1305/BNT325 for advanced solid tumors[11] Condensed Consolidated Financial Statements This section provides the unaudited condensed consolidated financial statements and detailed notes for H1 2025, offering a comprehensive financial overview Condensed Consolidated Statement of Comprehensive Income Revenue grew, but loss significantly increased due to fair value changes of financial liabilities Key Data from Condensed Consolidated Statement of Comprehensive Income | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Revenue | 1,228,934 | 999,826 | | Cost of Sales | (639,534) | (431,621) | | Gross Profit | 589,400 | 568,205 | | Research and Development Expenses | (349,387) | (377,579) | | Administrative Expenses | (125,548) | (73,276) | | Operating Profit | 107,028 | 127,237 | | Fair Value Changes of Financial Liabilities at Fair Value Through Profit or Loss | (2,219,785) | (421,269) | | Loss for the Period | (2,073,865) | (293,438) | | Basic and Diluted Loss Per Share (RMB) | (49.7) | (36.7) | Condensed Consolidated Statement of Financial Position Total assets increased, with cash and cash equivalents significantly up, while fair value financial liabilities decreased Key Data from Condensed Consolidated Statement of Financial Position | Indicator | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Total Assets | 4,177,030 | 2,090,222 | | Cash and Cash Equivalents | 2,994,180 | 1,208,906 | | Trade Receivables | 288,277 | 379,021 | | Total Equity / (Loss) | 2,912,761 | (2,021,899) | | Financial Liabilities at Fair Value Through Profit or Loss | 509 | 3,046,784 | | Total Liabilities | 1,264,269 | 4,112,121 | - The company's total equity turned from a loss at the end of 2024 to a positive value as of June 30, 2025, primarily due to the global offering and conversion of preferred shares into ordinary shares[13][50] Notes to the Condensed Consolidated Financial Statements This section provides detailed notes covering general information, accounting policies, segment data, expenses, taxation, loss per share, and post-balance sheet events 1. General Information InnoCare Bio was incorporated in the Cayman Islands on July 3, 2019, and listed on the Main Board of the HKEX on April 15, 2025, raising funds through a global offering; the Group is a global clinical-stage biopharmaceutical company focused on next-generation antibody-drug conjugate (ADC) therapies - The company was listed on the Main Board of the Stock Exchange of Hong Kong on April 15, 2025, raising total proceeds of RMB 1,524,008 thousand through a global offering, with an additional RMB 228,145 thousand raised on May 9, 2025, from the exercise of the over-allotment option[15] - The Group is a global clinical-stage biopharmaceutical company primarily engaged in the discovery and development of next-generation antibody-drug conjugate therapies in China and the United States[16] 2. Basis of Preparation The unaudited interim condensed consolidated financial statements for the six months ended June 30, 2025, are prepared in accordance with HKAS 34 Interim Financial Reporting and the Listing Rules, and should be read in conjunction with the audited annual financial statements for the year ended December 31, 2024 - The interim condensed consolidated financial statements are prepared in accordance with HKAS 34 and the Listing Rules, and do not include all information required for annual financial statements[17] 3. Changes in Accounting Policies The revised Hong Kong Financial Reporting Standards adopted for the first time in this interim period have no significant impact on the Group's financial position, performance, or disclosures - The application of new and revised HKFRSs (such as HKAS 21 (Amendment) Lack of Exchangeability) in this interim period has no significant impact on the Group's financial position and performance[18][19] 4. Segment and Revenue Information The company primarily engages in new drug research and development, with management reviewing business results as a single operating segment; revenue mainly derives from licensing and collaboration agreements, including upfront payments, R&D cost reimbursements, milestone payments, and royalties - The Group has only one operating segment, which is new drug research and development[21] - Revenue primarily comes from licensing and collaboration agreements, including non-refundable upfront payments, reimbursement of R&D costs incurred, and variable consideration (milestone payments and royalties)[22] Revenue Breakdown by Type | Revenue Type | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Licensing and Collaboration Agreement Revenue | 1,227,245 | 998,315 | | Others | 1,689 | 1,511 | | Total | 1,228,934 | 999,826 | 5. Expenses by Nature For the six months ended June 30, 2025, total expenses increased to RMB 1,114,469 thousand from RMB 882,476 thousand in the prior period, primarily driven by technical service expenses and employee benefit expenses Breakdown of Expenses by Nature | Expense Type | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Technical Service Expenses | 823,200 | 638,909 | | Employee Benefit Expenses | 198,968 | 193,549 | | Listing Expenses | 36,043 | – | | Professional Service Fees | 13,098 | 11,532 | | Depreciation and Amortization | 5,672 | 3,370 | | Impairment of Intangible Assets | – | 21,350 | | Total | 1,114,469 | 882,476 | 6. Employee Benefit Expenses For the six months ended June 30, 2025, total employee benefit expenses were RMB 198,968 thousand, slightly higher than RMB 193,549 thousand in the prior period, mainly comprising wages, salaries, and bonuses Breakdown of Employee Benefit Expenses | Expense Type | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Wages, Salaries and Bonuses | 98,602 | 53,821 | | Share-based Payment Expenses | 87,727 | 131,718 | | Social Insurance | 12,080 | 7,730 | | Other Employee Benefits | 559 | 280 | | Total | 198,968 | 193,549 | - The company's employees participate in government-sponsored defined contribution retirement schemes and other social insurance plans, with monthly contributions made[27] 7. Other Income For the six months ended June 30, 2025, other income decreased to RMB 1,092 thousand from RMB 1,703 thousand in the prior period, primarily due to reduced government grants Breakdown of Other Income | Income Type | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Government Grants | 713 | 1,498 | | Others | 379 | 205 | | Total | 1,092 | 1,703 | 8. Other (Losses) / Gains, Net For the six months ended June 30, 2025, the company recorded other net losses of RMB 8,529 thousand, compared to net gains of RMB 8,184 thousand in the prior period, mainly due to exchange losses Breakdown of Other (Losses) / Gains, Net | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Net Exchange (Losses) / Gains | (9,864) | 7,336 | | Others | 1,335 | 848 | | Total | (8,529) | 8,184 | 9. Finance Income and Costs For the six months ended June 30, 2025, net finance income was RMB 38,892 thousand, primarily from bank deposit interest income, while finance costs mainly comprised interest expenses on lease liabilities and discounted notes Breakdown of Finance Income and Costs | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Finance Income from Bank Deposits | 39,465 | 26,316 | | Interest Expense on Lease Liabilities | (104) | (132) | | Interest Expense on Discounted Notes | (469) | – | | Net Finance Income | 38,892 | 26,184 | 10. Income Tax Expense The company applies different income tax rates across jurisdictions, including Cayman Islands exemption, Hong Kong profits tax, US federal and state income taxes, and PRC enterprise income tax incentives; for the six months ended June 30, 2025, income tax expense decreased to zero, mainly due to no withholding tax on current period revenue - Cayman Islands companies are exempt from income tax; Hong Kong subsidiaries are subject to a two-tiered profits tax rate, but have no estimated assessable profits[32][33] - US subsidiaries are subject to 21% federal income tax and state/local income taxes; PRC subsidiaries enjoy enterprise income tax incentives based on High and New Technology Enterprise status and technology transfer income[34][35][36] Income Tax Expense | Indicator | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Income Tax Expense | – | 25,590 | 11. Loss Per Share For the six months ended June 30, 2025, basic loss per share expanded to RMB 49.7 from RMB 36.7 in the prior period; diluted loss per share is the same as basic loss per share as potential dilutive ordinary shares (share options and convertible preferred shares) were anti-dilutive due to the loss incurred Calculation of Basic Loss Per Share | Indicator | 2025 | 2024 | | :--- | :--- | :--- | | Loss Attributable to Ordinary Equity Holders of the Company (RMB thousands) | (2,073,865) | (293,438) | | Weighted Average Number of Ordinary Shares in Issue (thousands) | 41,704 | 8,000 | | Basic Loss Per Share (RMB) | (49.7) | (36.7) | - Due to the Group's loss for the period, potential ordinary shares (share options and convertible preferred shares) had an anti-dilutive effect, thus diluted loss per share is the same as basic loss per share[43][44] 12. Trade Receivables As of June 30, 2025, net trade receivables decreased to RMB 288,277 thousand from RMB 379,021 thousand as of December 31, 2024, primarily due to a reduction in uncollected amounts; customers typically have credit terms of 12 to 45 days Net Trade Receivables | Indicator | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Trade Receivables - Net | 288,277 | 379,021 | Ageing Analysis of Trade Receivables (Based on Invoice Date) | Ageing | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Within 30 days | 288,277 | 377,783 | | 31 to 60 days | – | 1,238 | | Total | 288,277 | 379,021 | 13. Financial Liabilities at Fair Value Through Profit or Loss As of June 30, 2025, financial liabilities measured at fair value significantly decreased to RMB 509 thousand, primarily due to the conversion of preferred shares into ordinary shares during the global offering; the company entered into foreign exchange swap contracts to mitigate exchange rate fluctuations Financial Liabilities at Fair Value Through Profit or Loss | Indicator | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Foreign Exchange Swaps | 509 | – | | Preferred Shares | – | 3,046,784 | | Total | 509 | 3,046,784 | - Preferred shares were converted into ordinary shares during the global offering, leading to the derecognition of these financial liabilities from the balance sheet[50] - The company entered into two foreign exchange swap contracts to mitigate the impact of RMB to USD exchange rate fluctuations, with a total outstanding notional principal of USD 8,000,000[48][49] 14. Trade Payables As of June 30, 2025, trade payables remained relatively stable at RMB 666,778 thousand, compared to RMB 670,910 thousand as of December 31, 2024, primarily related to research and development activities Ageing Analysis of Trade Payables (Based on Invoice Date) | Ageing | June 30, 2025 (RMB thousands) | December 31, 2024 (RMB thousands) | | :--- | :--- | :--- | | Within 6 months | 666,714 | 670,199 | | 6 to 12 months | 48 | 711 | | Over 12 months | 16 | – | | Total | 666,778 | 670,910 | 15. Dividends For the six months ended June 30, 2025, and 2024, neither the company nor any of its constituent entities declared or paid any dividends - No dividends were paid or declared during the reporting period[52] 16. Material Post-Balance Sheet Events No material post-balance sheet events occurred after the reporting period ended on June 30, 2025 - No material post-balance sheet events occurred after the reporting period[53] Business Overview Established in 2019, the company is a major global ADC player, developing innovative drugs for cancer and autoimmune diseases, with four leading ADC technology platforms and a pipeline of 13 self-developed candidates, accelerating global development through strategic partnerships Overview Established in 2019, InnoCare Bio focuses on becoming a major global player in antibody-drug conjugates (ADCs) by discovering and developing ADC assets for cancer and autoimmune diseases, having built four leading ADC technology platforms and a pipeline of 13 self-developed ADC candidates - The company was established in 2019, focusing on the ADC field and dedicated to developing innovative drugs for cancer and autoimmune diseases[54] - Four leading ADC technology platforms and a pipeline of 13 self-developed ADC candidates have been established[54] Product Pipeline The company's pipeline includes two core products, DB-1303/BNT323 (HER2 ADC) and DB-1311/BNT324 (B7-H3 ADC), six other clinical-stage ADCs, and multiple preclinical ADCs covering a wide range of indications, with DB-1421 (BsADC) expected to enter clinical stage in 2026 - Core products include DB-1303/BNT323 (HER2 ADC) and DB-1311/BNT324 (B7-H3 ADC), for treating various cancers[55] - The pipeline also includes six other clinical-stage ADCs (e.g., DB-1310, DB-1305/BNT325, DB-1419) and multiple preclinical ADCs, with DB-1421 (BsADC) expected to enter clinical development in 2026[55] Our Core Products The company's core products, DB-1303/BNT323 (HER2 ADC) and DB-1311/BNT324 (B7-H3 ADC), are actively advancing in global clinical development, both having received FDA Fast Track designation and demonstrating positive efficacy and manageable safety in multiple clinical trials DB-1303/BNT323 DB-1303/BNT323, a HER2 ADC, has received FDA Fast Track and Breakthrough Therapy designations, as well as CDE Breakthrough Therapy designation in China, for advanced EC patients; it is undergoing multiple global registrational clinical trials, with BioNTech collaboration accelerating development, and a BLA submission to the CDE for HER2+ breast cancer expected by end of 2025 - DB-1303/BNT323 has received FDA Fast Track and Breakthrough Therapy designations, as well as CDE Breakthrough Therapy designation in China, for advanced EC patients[60] - A global Phase 3 clinical trial (DYNASTY-Breast02) for HR+, HER2-low breast cancer patients is ongoing, and a Phase 3 trial for advanced endometrial cancer patients is expected to start in 2025[61] - A BLA for DB-1303/BNT323 for HER2+ breast cancer is expected to be submitted to the CDE by the end of 2025[61] DB-1311/BNT324 DB-1311/BNT324, a B7-H3 ADC, has received FDA Fast Track designation for advanced CRPC patients and Orphan Drug designation for ESCC and SCLC; it demonstrated manageable safety and encouraging preliminary clinical activity in a Phase 1/2 clinical trial in CRPC patients, with a confirmed ORR of 30.8% and DCR of 90.4% - DB-1311/BNT324 has received FDA Fast Track designation for advanced CRPC patients and Orphan Drug designation for ESCC and SCLC[62] - In multi-line treated CRPC patients, DB-1311/BNT324 showed a confirmed ORR of 30.8%, DCR of 90.4%, and a 6-month rPFS rate of 67.7%[62] - The company is actively exploring the potential of DB-1311/BNT324 as monotherapy and in combination with other treatments in various solid tumors, including combination trials with BNT116 (lung cancer vaccine) and BNT327 (bispecific antibody)[62] Our Key Products The company's key product pipeline includes DB-1310 (HER3 ADC), DB-1305/BNT325 (TROP2 ADC), DB-1419 (B7-H3xPD-L1 BsADC), DB-1418/AVZO-1418 (EGFRxHER3 BsADC), and DB-2304 (BDCA2 ADC), all in leading clinical positions and showing potential for treating various cancers and autoimmune diseases DB-1310 DB-1310, one of the most clinically advanced HER3 ADCs globally, has received FDA Fast Track designation for specific advanced non-small cell lung cancer; in its first-in-human Phase 1/2 clinical trial, DB-1310 demonstrated encouraging efficacy in EGFRm NSCLC patients, with an unconfirmed ORR of 43.5%, DCR of 91.3%, and median PFS of 7.03 months - DB-1310 has received FDA Fast Track designation for treating EGFRm nsqNSCLC patients whose disease progressed after third-generation EGFR TKI and platinum-based chemotherapy[64] - In EGFRm NSCLC patients, DB-1310 showed an unconfirmed ORR of 43.5%, DCR of 91.3%, and median PFS of 7.03 months[63] - The company is exploring the potential of DB-1310 in combination with osimertinib for EGFRm NSCLC patients, and its efficacy in other solid tumors such as breast cancer and CRPC[63] DB-1305/BNT325 DB-1305/BNT325, a TROP2 ADC, has received FDA Fast Track designation for platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer patients; in a Phase 1/2 clinical trial, it demonstrated manageable safety and early anti-tumor activity in PROC patients, with an ORR of 41.4% and DCR of 82.8% - DB-1305/BNT325 has received FDA Fast Track designation for treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer[65] - In PROC patients, DB-1305/BNT325 showed an ORR of 41.4%, DCR of 82.8%, median DOR of 7.3 months, and median PFS of 7.4 months[66] - The combination therapy of DB-1305/BNT325 with BNT327 (PD-L1xVEGF bsAb) showed early signs of anti-tumor activity in PROC, NSCLC, or TNBC patients[66] DB-1419 DB-1419, the world's only B7-H3xPD-L1 BsADC in clinical development, has received IND approvals from the FDA and CDE, and initiated a Phase 1/2a global clinical trial in September 2024, aiming for synergistic anti-tumor effects through cytotoxic and immunotherapeutic activities - DB-1419 is the world's only B7-H3xPD-L1 BsADC in clinical development, capable of simultaneously delivering toxins and modulating T-cell activation[67] - It has received IND approvals from the FDA and CDE, and a Phase 1/2a global clinical trial was initiated in September 2024, currently recruiting patients with advanced/metastatic solid tumors[67] DB-1418/AVZO-1418 DB-1418 is a novel EGFRxHER3 BsADC, with preclinical data showing additive binding affinity in EGFR and HER3 co-expressing tumor cells and efficacy in EGFR TKI-resistant NSCLC models; the company has partnered with Avenzo, which has dosed its first patient in a Phase 1/2 clinical study - DB-1418 is a novel EGFRxHER3 BsADC, with preclinical data showing additive binding affinity in EGFR and HER3 co-expressing tumor cells and efficacy in EGFR TKI-resistant NSCLC models[68] - The company has entered into a collaboration and licensing agreement with Avenzo, granting exclusive worldwide rights (excluding Greater China) for development, manufacturing, and commercialization[68] DB-2304 DB-2304, an innovative BDCA2 ADC for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), is one of the most advanced BDCA2 ADCs in development; it employs a selective therapeutic approach, aiming to significantly improve side effects of existing lupus treatments, with a multi-dose escalation study expected to start by end of 2025 - DB-2304 is an innovative BDCA2 ADC for SLE and CLE, and is one of the most advanced BDCA2 ADCs in development[69] - This drug employs a selective therapeutic approach, targeting upstream signaling pathways in SLE/CLE pathogenesis, with the potential to improve side effects of existing treatments[69] - The company is currently advancing DB-2304's Phase 1 global trial and expects to initiate a multi-dose escalation study by the end of 2025[69] Proprietary ADC Platforms The company has developed four leading ADC technology platforms: DITAC (Immunotoxin), DIBAC (Bispecific), DIMAC (Immunomodulatory), and DUPAC (Unique Payload), aiming to push the boundaries of ADC therapy, address drug resistance and refractory tumors, and expand into autoimmune diseases DITAC (InnoCare Immunotoxin Antibody-Drug Conjugate Platform) DITAC, the company's proprietary topoisomerase inhibitor-based ADC platform, has demonstrated good tolerability in over 2,600 patients globally; through technological improvements and optimization of its proprietary component library, the platform aims to provide a wide therapeutic window, better systemic stability, tumor-specific payload release, and bystander killing effect - DITAC is a topoisomerase inhibitor-based ADC platform, with good tolerability validated in over 2,600 patients globally[73] - The platform aims to provide a wide therapeutic window, better systemic stability, tumor-specific payload release, bystander killing effect, and rapid toxin payload clearance capabilities[73] DIBAC (InnoCare Innovative Bispecific Antibody-Drug Conjugate Platform) DIBAC, the company's innovative bispecific antibody-drug conjugate platform, aims to achieve superior efficacy compared to traditional monospecific ADCs by integrating two different binding moieties into a single drug; this platform combines bispecific antibody engineering with AI-enabled target selection and antibody design expertise - DIBAC is one of the few BsADC platforms globally, aiming to achieve superior efficacy over traditional monospecific ADCs by integrating two different binding moieties[73] - The platform combines bispecific antibody engineering and AI-enabled target selection and antibody design expertise[73] DIMAC (InnoCare Immunomodulatory Antibody-Drug Conjugate Platform) DIMAC, the company's proprietary immunomodulatory antibody-drug conjugate platform, carries immunomodulatory payloads and aims to address significant unmet needs in autoimmune and other therapeutic areas; molecules developed on this platform have shown effective and broad anti-inflammatory activity in preclinical studies, with the potential to reshape autoimmune disease treatment through targeted therapy - DIMAC is one of the few ADC platforms targeting major autoimmune diseases, carrying proprietary immunomodulatory payloads[75] - Molecules developed on this platform have shown effective and broad anti-inflammatory activity in preclinical studies, with the potential to reshape autoimmune disease treatment through targeted therapy[75] DUPAC (InnoCare Unique Payload Antibody-Drug Conjugate Platform) DUPAC is one of the company's ADC platforms dedicated to developing linker-payload complexes with novel mechanisms of action superior to traditional cytotoxic drugs, aiming to address drug-resistant and refractory tumors; DUPAC has shown potential to overcome resistance to Dxd and other topoisomerase inhibitors - DUPAC is one of the ADC platforms dedicated to developing linker-payload complexes with novel mechanisms of action, aiming to address drug-resistant and refractory tumors[75] - DUPAC has shown potential to overcome resistance to Dxd and other topoisomerase inhibitors[75] Collaboration and Licensing Arrangements The company has established a series of global strategic partnerships, including with BioNTech, BeiGene, Adcendo, GSK, and Avenzo, with total transaction values exceeding USD 6 billion, aimed at accelerating pipeline development in key global markets, expanding clinical development capabilities, and fostering future innovation Strategic Partnership with BioNTech The company has entered into three licensing and collaboration agreements with BioNTech for DB-1303, DB-1311, and DB-1305, granting BioNTech exclusive worldwide development, manufacturing, and commercialization rights (excluding Greater China), while the company retains rights in Greater China; both parties are actively exploring the therapeutic potential of these drugs through comprehensive global clinical development programs - Three licensing and collaboration agreements have been reached with BioNTech, involving DB-1303, DB-1311, and DB-1305[75] - BioNTech obtained exclusive worldwide rights (excluding Greater China) for development, manufacturing, and commercialization, while the company retains rights in Greater China[76] - BioNTech granted the company an exclusive option to co-develop and co-commercialize DB-1311 in the United States, sharing costs and profits[76] Collaboration with BeiGene The company has granted BeiGene global development and commercialization rights for DB-1312 (B7-H4 targeting ADC); BeiGene is currently advancing the single-agent dose escalation of DB-1312 in its Phase 1 trial - The company has granted BeiGene global development and commercialization rights for DB-1312 (B7-H4 targeting ADC)[77] - BeiGene is currently advancing the ongoing single-agent dose escalation of DB-1312 in its Phase 1 trial[77] Collaboration with Adcendo The company established a strategic partnership with Adcendo in 2022, where Adcendo utilizes the company's proprietary DITAC platform to advance new programs, including uPARAP-targeting ADCs; in November 2024, a new licensing agreement was reached to develop an ADC product targeting another target using the DITAC platform - A strategic partnership was established with Adcendo, where Adcendo utilizes the company's proprietary DITAC platform to advance new programs, including uPARAP-targeting ADCs[78] - In November 2024, a new licensing agreement was reached to develop an ADC product targeting another target using the DITAC platform[78] Collaboration with GSK The company entered into an exclusive option agreement with GSK for DB-1324 (a preclinical ADC asset developed using the DITAC platform); GSK paid an upfront fee of USD 30 million and agreed to pay additional milestone payments; if GSK exercises the option, the company is eligible for an option exercise fee, potential milestone payments, and tiered royalties - An exclusive option agreement was reached with GSK for DB-1324 (a preclinical ADC asset), granting GSK worldwide development and commercialization options (excluding Greater China)[79] - GSK paid an upfront fee of USD 30 million and agreed to pay additional pre-option exercise milestone payments[79] Collaboration with Avenzo The company entered into a collaboration and licensing agreement with Avenzo, granting Avenzo exclusive worldwide rights (excluding Greater China) to develop, manufacture, and commercialize DB-1418 (EGFR/HER3 BsADC) - A collaboration and licensing agreement was reached with Avenzo, granting exclusive worldwide rights (excluding Greater China) to develop, manufacture, and commercialize DB-1418[80] Manufacturing The company outsources its manufacturing activities to Contract Development and Manufacturing Organizations (CDMOs) to support drug development, a model it plans to maintain in the short term and early commercialization for cost-effectiveness and efficiency, continuing to collaborate with leading CDMOs to optimize manufacturing processes - The company's manufacturing activities are outsourced to CDMOs to support drug development, a model planned to continue in the short term and early commercialization[81] - The company has entered into long-term master service agreements with CDMO partners and places specific orders based on R&D activities[81] Commercialization The company has not yet obtained marketing approval for any candidate drugs but has developed a cross-functional commercialization plan to support the anticipated launch of DB-1303 in the Chinese market, including establishing a manufacturing supply chain, preparing marketing applications, and building a core commercialization team; a collaboration agreement has been signed with 3SBio, appointing them as the commercialization partner for DB-1303 in Greater China - The company has not yet obtained marketing approval for any candidate drugs but has developed a cross-functional commercialization plan to support the anticipated launch of DB-1303 in the Chinese market[82] - A collaboration agreement has been signed with 3SBio, appointing them as the commercialization partner for DB-1303 in mainland China, Hong Kong, and Macau[82] Management Discussion and Analysis This section details the company's H1 2025 financial performance, including revenue growth, expense changes, loss expansion, balance sheet movements, and cash flow, emphasizing the impact of financial liability fair value changes and the global offering's positive effect on capital Overview For the six months ended June 30, 2025, the company's total revenue increased to RMB 1,228.9 million, but loss for the period significantly increased to RMB 2,073.9 million, primarily due to fair value changes of financial liabilities; R&D expenses decreased, while administrative expenses, cost of sales, and finance income all increased - Total revenue was RMB 1,228.9 million, representing a 22.9% year-on-year increase[83] - Loss for the period was RMB 2,073.9 million, a significant increase from RMB 293.4 million in the prior period, primarily due to fair value changes of financial liabilities measured at fair value through profit or loss, resulting in a loss of RMB 2,219.8 million[83] - Research and development expenses decreased by 7.5% to RMB 349.4 million, while administrative expenses increased by 71.2% to RMB 125.5 million[83] Revenue For the six months ended June 30, 2025, the company's total revenue was RMB 1,228.9 million, a 22.9% year-on-year increase, primarily driven by the further expansion of R&D activities through out-licensing and collaboration agreements Revenue Breakdown | Revenue Type | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Licensing and Collaboration Agreement Revenue | 1,227,245 | 998,315 | | Others | 1,689 | 1,511 | | Total | 1,228,934 | 999,826 | - The increase in revenue was primarily due to the further expansion of R&D activities through out-licensing and collaboration agreements[84] Cost of Sales For the six months ended June 30, 2025, cost of sales increased to RMB 639.5 million, a 48.2% increase from RMB 431.6 million in the prior period, primarily due to further clinical development of collaboration projects - Cost of sales increased to RMB 639.5 million, representing a 48.2% year-on-year increase[86] - The increase in cost of sales was primarily due to further clinical development of collaboration projects[86] Gross Profit and Gross Margin For the six months ended June 30, 2025, gross profit was RMB 589.4 million, slightly higher than RMB 568.2 million in the prior period, while gross margin decreased from 56.8% to 48.0% - Gross profit was RMB 589.4 million, with a gross margin of 48.0%[87] - Gross margin decreased by 8.8 percentage points year-on-year, from 56.8% to 48.0%[87] Research and Development Expenses For the six months ended June 30, 2025, research and development expenses decreased to RMB 349.4 million, a 7.5% year-on-year decrease, primarily due to reduced share-based payment expenses and no asset impairment losses recognized Research and Development Expenses Breakdown | Expense Type | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Technical Service Expenses | 231,782 | 227,845 | | Staff Costs | 105,676 | 121,479 | | Asset Impairment Loss | – | 21,350 | | Total | 349,387 | 377,579 | - The decrease in R&D expenses was primarily due to reduced share-based payment expenses recognized during the vesting period of the share incentive scheme, and no asset impairment losses recognized in H1 2025[88] Administrative Expenses For the six months ended June 30, 2025, administrative expenses increased to RMB 125.5 million, a 71.2% year-on-year increase, primarily due to listing expenses incurred in H1 2025 - Administrative expenses increased to RMB 125.5 million, representing a 71.2% year-on-year increase[90] - The increase in administrative expenses was primarily due to listing expenses incurred in H1 2025[90] Other Income For the six months ended June 30, 2025, other income decreased to RMB 1.1 million, a 35.3% year-on-year decrease, primarily due to reduced government grants - Other income decreased to RMB 1.1 million, representing a 35.3% year-on-year decrease[91] - The decrease in other income was primarily due to reduced government grants[91] Other (Losses) / Gains, Net For the six months ended June 30, 2025, the company recorded other net losses of RMB 8.5 million, compared to net gains of RMB 8.2 million in the prior period, primarily due to exchange rate fluctuations between USD, RMB, and HKD - Other net losses of RMB 8.5 million were recorded, compared to net gains of RMB 8.2 million in the prior period[92] - The change was primarily due to exchange rate fluctuations between USD, RMB, and HKD[92] Finance Income For the six months ended June 30, 2025, finance income increased to RMB 39.5 million, a 50.2% year-on-year increase, primarily from bank deposit interest income - Finance income increased to RMB 39.5 million, representing a 50.2% year-on-year increase[93] - Finance income primarily refers to interest income from bank deposits[93] Finance Costs For the six months ended June 30, 2025, finance costs increased to RMB 0.6 million, primarily due to bank interest expenses on discounted notes - Finance costs increased to RMB 0.6 million, primarily due to bank interest expenses on discounted notes[94] Fair Value Changes of Financial Liabilities at Fair Value Through Profit or Loss For the six months ended June 30, 2025, fair value changes of financial liabilities measured at fair value through profit or loss resulted in a loss of RMB 2,219.8 million, a significant increase from RMB 421.3 million in the prior period, primarily due to fair value changes of preferred shares issued prior to the global offering - Fair value changes resulted in a loss of RMB 2,219.8 million, compared to a loss of RMB 421.3 million in the prior period[95] - The change primarily refers to fair value changes of preferred shares issued through equity financing prior to the global offering[95] Income Tax Expense For the six months ended June 30, 2025, income tax expense decreased to zero, compared to RMB 25.6 million in the prior period, primarily due to no withholding tax on revenue recognized in H1 2025 - Income tax expense decreased to zero, compared to RMB 25.6 million in the prior period[96] - The decrease was primarily due to no withholding tax on revenue recognized in H1 2025[96] Loss for the Period Due to the combined effect of the aforementioned factors, the Group's loss for the six months ended June 30, 2025, significantly increased from RMB 293.4 million in the prior period to RMB 2,073.9 million - Loss for the period increased from RMB 293.4 million to RMB 2,073.9 million, an increase of RMB 1,780.5 million[97] Property, Plant and Equipment As of June 30, 2025, property, plant and equipment remained relatively stable at RMB 13.5 million, primarily comprising office and facility equipment, leasehold improvements, and construction in progress - Property, plant and equipment remained relatively stable at RMB 13.5 million as of June 30, 2025[98] Intangible Assets As of June 30, 2025, intangible assets decreased by RMB 6.8 million to RMB 39.4 million, primarily due to certain amounts being recognized as cost of sales under out-licensing arrangements - Intangible assets decreased by RMB 6.8 million to RMB 39.4 million[99] - The decrease was primarily due to certain amounts being recognized as cost of sales under out-licensing arrangements[99] Other Current Assets and Other Non-Current Assets As of June 30, 2025, other current assets and other non-current assets combined decreased to RMB 48.6 million, primarily due to the receipt of tax refunds related to withholding tax in H1 2025 - Other current assets and other non-current assets combined decreased to RMB 48.6 million[100] - The decrease was primarily due to the receipt of tax refunds related to withholding tax in H1 2025[100] Right-of-Use Assets As of June 30, 2025, right-of-use assets decreased by RMB 0.9 million to RMB 4.6 million, primarily due to depreciation of right-of-use assets - Right-of-use assets decreased by RMB 0.9 million to RMB 4.6 million[101] - The decrease was primarily due to depreciation of right-of-use assets[101] Trade Receivables As of June 30, 2025, trade receivables decreased to RMB 288.3 million from RMB 379.0 million as of December 31, 2024, primarily due to a reduction in uncollected amounts at the corresponding period-end - Trade receivables decreased to RMB 288.3 million[102] - The decrease was primarily due to a reduction in uncollected amounts at the corresponding period-end[102] Prepayments and Other Receivables As of June 30, 2025, prepayments and other receivables remained relatively stable at RMB 25.6 million, primarily dependent on R&D activities and business operations - Prepayments and other receivables remained relatively stable at RMB 25.6 million[103] Cash and Cash Equivalents As of June 30, 2025, cash and cash equivalents increased significantly to RMB 2,994.2 million from RMB 1,208.9 million as of December 31, 2024, primarily due to proceeds from the company's listing on the HKEX in H1 2025 - Cash and cash equivalents increased to RMB 2,994.2 million, representing a 147.7% year-on-year increase[104] - The increase was primarily due to proceeds from the company's listing on the Stock Exchange of Hong Kong in H1 2025[104] Fixed Deposits with Original Maturity Over Three Months As of June 30, 2025, fixed deposits with original maturity over three months increased significantly to RMB 707.0 million from RMB 181.8 million as of December 31, 2024 - Fixed deposits with original maturity over three months increased to RMB 707.0 million, representing a 288.9% year-on-year increase[105] Trade Payables As of June 30, 2025, trade payables remained relatively stable at RMB 666.8 million, primarily related to research and development activities - Trade payables remained relatively stable at RMB 666.8 million[106] Other Payables As of June 30, 2025, other payables remained relatively stable at RMB 58.6 million, primarily including employee salaries and benefits payable, and listing expenses payable - Other payables remained relatively stable at RMB 58.6 million[107] Lease Liabilities As of June 30, 2025, lease liabilities decreased to RMB 4.5 million, primarily due to ongoing payments for lease contracts - Lease liabilities decreased to RMB 4.5 million[108] - The decrease was primarily due to ongoing payments for lease contracts[108] Contract Liabilities As of June 30, 2025, contract liabilities decreased to RMB 298.6 million, primarily due to RMB 63.6 million of revenue recognized from contract liabilities at the beginning of the year - Contract liabilities decreased to RMB 298.6 million[109] - The decrease was primarily due to RMB 63.6 million of revenue recognized from contract liabilities at the beginning of the year[109] Financial Liabilities at Fair Value Through Profit or Loss As of June 30, 2025, financial liabilities measured at fair value significantly decreased, primarily due to the conversion of preferred shares into ordinary shares after listing, and their derecognition from liabilities - Preferred shares were converted into ordinary shares after listing, leading to the derecognition of these financial liabilities from liabilities and their reclassification as equity[110] Bank Borrowings As of June 30, 2025, bank borrowings increased to RMB 63.4 million, primarily due to discounted notes with maturities within six months - Bank borrowings increased to RMB 63.4 million, primarily due to discounted notes with maturities within six months[111] Other Non-Current Liabilities As of June 30, 2025, other non-current liabilities increased to RMB 169.5 million, primarily due to non-refundable upfront payments related to the new 3SBio CSO collaboration agreement - Other non-current liabilities increased to RMB 169.5 million, primarily due to upfront payments from the new 3SBio CSO collaboration agreement[112] Cash Flows For the six months ended June 30, 2025, net cash inflow from operating activities significantly increased, net cash outflow from investing activities increased, and net cash inflow from financing activities significantly increased, primarily benefiting from initial public offering proceeds Cash Flow Summary | Cash Flow Type | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Net Cash Inflow from Operating Activities | 589,762 | 178,389 | | Net Cash Outflow from Investing Activities | (520,929) | (164,162) | | Net Cash Inflow / (Outflow) from Financing Activities | 1,729,329 | (1,605) | | Net Increase in Cash and Cash Equivalents | 1,798,162 | 12,622 | | Cash and Cash Equivalents at End of Period | 2,994,180 | 1,147,960 | - Net cash inflow from operating activities increased, primarily due to more funds received from collaboration arrangements and tax refunds for withholding tax and VAT[113] - Net cash inflow from financing activities significantly increased, primarily from proceeds of the initial public offering completed in H1 2025[114] Liquidity and Capital Resources The company primarily meets its working capital needs through proceeds from the global offering and pre-IPO financing, managing financial activities centrally to control funding costs; the company believes it has sufficient funds to meet working capital and capital expenditure needs for H2 2025 - The company primarily meets its working capital needs through proceeds from the global offering and pre-IPO financing[115] - The company believes it has sufficient funds to meet working capital and capital expenditure needs for H2 2025[116] Key Financial Ratios As of June 30, 2025, the company's current ratio was 4.7, a significant improvement from 0.5 as of December 31, 2024; the gearing ratio is not applicable due to negative interest-bearing borrowings less cash equivalents Key Financial Ratios | Indicator | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Current Ratio | 4.7 | 0.5 | | Gearing Ratio | Not Applicable | Not Applicable | - The current ratio significantly improved, indicating a substantial strengthening of the company's short-term solvency[117][121] Material Investments For the six months ended June 30, 2025, the company made no material investments and currently has no plans for material investments or additions to significant capital assets - No material investments were made during the reporting period, and there are no future plans for material investments[117] Material Acquisitions and Disposals For the six months ended June 30, 2025, the company had no material acquisitions or disposals of subsidiaries, associates, or joint ventures - No material acquisitions or disposals occurred during the reporting period[118] Contingent Liabilities As of June 30, 2025, the company had no material contingent liabilities, guarantees, or pending litigations that could significantly adversely affect its business, financial condition, or operating results - As of June 30, 2025, the company had no material contingent liabilities, guarantees, or pending litigations[119] Foreign Exchange Risk The company primarily operates in China, with most transactions settled in RMB, but as of June 30, 2025, a significant portion of bank balances and cash were denominated in USD; the company currently has no foreign currency hedging policy, but management monitors foreign exchange risk and considers hedging when necessary - The company's majority of transactions are settled in RMB, but a significant portion of bank balances and cash are denominated in USD as of June 30, 2025[120] - The company currently has no foreign currency hedging policy, but management monitors foreign exchange risk and considers hedging when necessary[120] Employees and Remuneration Policy As of June 30, 2025, the company had 191 employees, with total remuneration costs of RMB 199.0 million; remuneration includes salaries, bonuses, and equity incentives, with social insurance and housing provident fund contributions made in accordance with Chinese laws and regulations - As of June 30, 2025, the company had 191 employees, an increase of 54 from the prior period[122] - Total remuneration costs were RMB 199.0 million, a slight increase from RMB 193.5 million in the prior period[122] - The company has adopted a pre-IPO share incentive scheme to provide incentives to employees[123] Future Developments The company aims to be a global leader in innovative ADC therapies, following the "CP2" strategy (Clinical Development, Platforms, and Pipeline) to accelerate global development and commercialization of clinical-stage projects, enhancing research, clinical, and regulatory expertise - The company's mission is to be a global leader in the discovery, development, and commercialization of innovative ADC therapies[124] - It follows the "CP2" strategy (Clinical Development, Platforms, and Pipeline) and aims to expand it into global markets[124] - Future plans include accelerating global development and commercialization of clinical-stage projects, and continuously strengthening global research, clinical development, and regulatory expertise[124] Interim Dividend The Board does not recommend paying an interim dividend to shareholders for the six months ended June 30, 2025 - The Board does not recommend paying an interim dividend for the six months ended June 30, 2025[125] Capital Structure The company's shares were listed on the Main Board of the Stock Exchange on the listing date, with no material changes to the capital structure since then, except as disclosed in this announcement - The company's shares were listed on the Main Board of the Stock Exchange on April 15, 2025[126] - There have been no material changes to the company's capital structure since the listing date[126] Future Plans for Material Investments and Capital Assets As of this announcement date, the Group has no plans for material investments and capital assets, other than those disclosed in the prospectus - As of the date of this announcement, the Group has no plans for material investments and capital assets[127] Corporate Governance and Other Information The company is committed to high corporate governance standards, adopting the Corporate Governance Code and Model Code, and has complied with all provisions from listing date to June 30, 2025, except for the combined Chairman and CEO roles Compliance with Corporate Governance Code The company has adopted the Corporate Governance Code and has complied with all applicable code provisions from the listing date to June 30, 2025, except for the combined roles of Chairman and Chief Executive Officer held by Dr. Zhu Zhongyuan, an arrangement the Board believes benefits business operations and management - The company has adopted the Corporate Governance Code as set out in Appendix C1 of the Listing Rules[129] - From the listing date to June 30, 2025, the company has complied with all applicable code provisions, except for the combined roles of Chairman and Chief Executive Officer held by Dr. Zhu Zhongyuan[129] Compliance with Model Code The company has adopted the Model Code, and all Directors have confirmed compliance from the listing date to June 30, 2025; the company has also established an inside information policy and found no instances of non-compliance by relevant employees - The company has adopted the Model Code as set out in Appendix C3 of the Listing Rules, and Directors have confirmed compliance[130] - The company has established an inside information policy and found no instances of non-compliance with the Model Code by relevant employees[130] Purchase, Sale or Redemption of Listed Securities From the listing date to this announcement, neither the company nor its subsidiaries purchased, sold, or redeemed any listed securities, and as of June 30, 2025, no treasury shares were held - From the listing date to the date of this announcement, neither the company nor its subsidiaries purchased, sold, or redeemed any of the company's listed securities[131] - As of June 30, 2025, the company held no treasury shares[132] Review of Interim Results The Group's unaudited condensed consolidated financial statements for the six months ended June 30, 2025, were reviewed by PricewaterhouseCoopers, and the Audit Committee confirmed proper preparation and disclosure - The interim condensed consolidated financial statements for the six months ended June 30, 2025, have been reviewed by PricewaterhouseCoopers in accordance with Hong Kong Standard on Review Engagements 2410[133] - The Audit Committee has reviewed this announcement and is satisfied that the financial information has been prepared in accordance with applicable accounting standards and properly disclosed[133] Use of Net Proceeds from Global Offering Net proceeds from the global offering totaled approximately HKD 1,747.5 million, with HKD 147.8 million utilized by June 30, 2025, primarily for R&D, commercialization, platform development, and working capital, with the remaining balance to be used over 3-4 years - Net proceeds from the global offering totaled approximately HKD 1,747.5 million (including the over-allotment option)[134][135] - As of June 30, 2025, approximately HKD 147.8 million of the net proceeds from the global offering had been utilized[135] Use and Allocation of Net Proceeds from Global Offering | Use | Allocation Ratio | Utilized Amount (HKD million) | Unutilized Amount (HKD million) | Expected Timeline | | :--- | :--- | :--- | :--- | :--- | | R&D and Commercialization of Core Products DB-1303 and DB-1311 | 45.0% | 64.1 | 722.3 | Next 3 to 4 years | | R&D of Key Products | 30.0% | 50.6 | 473.7 | Next 3 to 4 years | | Ongoing Development of ADC Technology Platforms and Other Pipeline Assets | 15.0% | 20.9 | 241.2 | Next 3 to 4 years | | Working Capital and Other General Corporate Purposes | 10.0% | 12.2 | 162.5 | Next 3 to 4 years | | Total | 100.0% | 147.8 | 1,599.7 | | Key Risks and Uncertainties The company's business, financial condition, and operating results may be materially and adversely affected by certain risks and uncertainties, detailed in the prospectus's "Risk Factors" se