嘉和生物(06998) - 2025 - 中期业绩

Company Profile and Financial Overview This section provides an overview of the company's business, key financial highlights, and strategic business developments for the reporting period Company Profile Jiahe Biotech (Cayman) Holdings Co., Ltd. (the Group) released its unaudited interim results for the six months ended June 30, 2025, focusing on oncology and autoimmune disease drug development and commercialization - Jiahe Biotech (Cayman) Holdings Co., Ltd. announced its unaudited interim results for the six months ended June 30, 2025[3] - The Group primarily engages in the development and commercialization of oncology and autoimmune disease drugs[97] Financial Highlights The Group achieved significant revenue growth and a substantial reduction in losses during the reporting period, driven by increased licensing income and effective cost control in R&D and administrative expenses Report Period Key Financial Metrics Comparison | Metric | Six Months Ended June 30, 2025 (RMB million) | Six Months Ended June 30, 2024 (RMB million) | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenue | 32.2 | 14.5 | +122.1 | | R&D Expenses | 74.6 | 109.7 | -32.0 | | Total Comprehensive Loss | 54.3 | 141.0 | -61.5 | | Adjusted Loss | 59.6 | 130.2 | -54.2 | - Total revenue growth was primarily attributable to the licensing and equity agreement with TRC 2004, Inc[5] - The decrease in R&D expenses was mainly due to reduced employee benefit expenses for R&D personnel and lower new drug development and clinical trial costs[5] Business Highlights The Group successfully transitioned to an asset-light operating model, reducing costs, while actively advancing strategic collaborations like the merger with EOC Pharma and progressing core pipeline assets, including the NMPA approval of Lerociclib - The Group successfully implemented an asset-light operating model, effectively reducing operating costs and enhancing efficiency[6] - Actively progressing the strategic merger with EOC Pharma, with a new listing application submitted to the Stock Exchange[6] - The Class 1 innovative drug Lerociclib Hydrochloride Tablets (Rujia'ning) received NMPA approval on May 27, 2025, for HR+/HER2- locally advanced or metastatic breast cancer[6] - Core pipeline GB268 (trispecific antibody) received NMPA approval for its Phase I clinical trial application and initiated; GB261 (bispecific antibody) clinical trials for autoimmune diseases have commenced outside Greater China[6] Key Business Progress During the Reporting Period This section details the Group's strategic implementation, successful asset-light transformation, key collaborations, and significant advancements in its core drug pipeline Overall Strategy and Operations Since 2022, the Group has implemented a "Focus, Optimize, Accelerate, Expand" strategy, successfully transitioning to an asset-light model, significantly reducing costs, and achieving NMPA approval for Lerociclib - The Group successfully launched its "Focus, Optimize, Accelerate, Expand" development strategy in 2022, achieving initial results in 2023[17] - During the reporting period, the company successfully achieved asset-light operations, significantly reducing operating costs[17] - The Class 1 innovative drug Lerociclib Hydrochloride Tablets (Rujia'ning) received NMPA approval on May 27, 2025, offering a new treatment option for patients[17] Strategic Collaborations and Commercialization The Group is progressing its merger with EOC Pharma, submitting a new listing application, and has entered into multiple agreements for the commercialization and medical insurance listing of innovative antibody drugs and Lerociclib (GB491) - The Group and EOC Pharma entered into a merger agreement on September 13, 2024, where the Company will acquire EOC Pharma through a merger, and a new listing application was submitted to the Stock Exchange on April 15, 2025[18][29] - The proposed merger is expected to bring complementary R&D capabilities and commercialization platforms, synergistic product pipelines and market expansion, and optimized integration of financial resources[18] - Cooperation development agreements were signed with EOC Pharma for two trispecific antibodies, GBD218 and GBD220, both in early discovery stages[19][30] - A cooperation agreement was signed with EOC Pharma and EOC (Suzhou) for Lerociclib (GB491), designating EOC (Suzhou) as the responsible party in China and exclusively entrusting it with medical insurance catalog application and implementation[19][20][30] Core Pipeline Drug Progress The Group's core pipeline drugs achieved rapid progress, with Lerociclib (GB491) approved for market, GB268 IND approved, and GB261 and GB263T showing promising clinical results - During this reporting period, the Company achieved rapid progress in its preclinical and clinical product pipeline, thanks to the high professionalism and close cross-departmental collaboration of its various departments[31] Lerociclib (GB491) Lerociclib (GB491) as a novel oral CDK4/6 inhibitor, has received NMPA approval for first-line and second-line treatment of HR+/HER2- locally advanced or metastatic breast cancer, demonstrating excellent efficacy and safety in multiple Phase III clinical studies, with localized production and commercialization preparations underway - NMPA approved Lerociclib (GB491) for marketing on May 27, 2025, for use in combination with letrozole for first-line advanced breast cancer, and in combination with fulvestrant for second-line advanced breast cancer[21][32][33] - The LEONARDA-1 study showed that Lerociclib + fulvestrant significantly reduced the risk of disease progression and death, with an investigator-assessed HR of 0.451 and a BICR-assessed HR of 0.353[33] - Lerociclib (GB491) features an innovative molecular structure and unique PK/PD characteristics, allowing for continuous oral administration and significantly reducing common adverse reactions such as myelosuppression and diarrhea[33] - Nature Communications published the results of the LEONARDA-1 Phase III study on January 16, 2025[22][34] - Localized production technology transfer for Lerociclib (GB491) is underway, and pre-market commercialization preparations have begun[35] GB268 (Anti-PD-1/VEGF/CTLA-4, Trispecific Antibody) GB268, an internally developed trispecific antibody, specifically targets PD-1, VEGF, and CTLA-4, with preclinical studies showing significantly enhanced anti-tumor effects and better safety. GMP pilot production and GLP toxicology studies have been completed, and its IND application was accepted by NMPA on May 9, 2025 - GB268 is the Group's independently developed trispecific antibody, specifically targeting PD-1, VEGF, and CTLA-4, featuring a novel molecular design with potential to be an upgraded immune checkpoint inhibitor[23][36] - Preclinical results showed that GB268 significantly enhanced anti-tumor effects and demonstrated better safety compared to single antibody combinations or bispecific antibodies[23][38] - GB268 completed two batches of GMP pilot production release in the first half of 2025, showing good batch consistency, high purity, and good stability[10][39] - A 4-week repeated dose GLP toxicology study in cynomolgus monkeys was completed in March 2025, with results indicating good safety and efficacy[10][39] - NMPA accepted GB268's IND application on May 9, 2025, and approved the initiation of its FIH Phase I clinical trial on July 17, 2025[10][23][40] GB261 (CD20/CD3, Bispecific Antibody) GB261 is the first TCE with low CD3 affinity and retained Fc function, demonstrating good safety and anti-tumor activity in lymphoma Phase I/II clinical trials. Licensee Candid Therapeutics, Inc. has initiated its clinical evaluation for autoimmune diseases and determined a subcutaneous formulation - GB261 is the first T-cell engager (TCE) with low CD3 affinity and retained Fc function (ADCC and CDC), poised to be a better and safer TCE therapeutic drug[11][41] - Phase I/II lymphoma clinical trials for GB261, conducted in Australia and China, have been completed, yielding good safety, pharmacokinetic characteristics, and clinical anti-tumor activity[11][24][41] - Preliminary results from the GB261 Phase I/II study were presented as a poster at the 65th American Society of Hematology Annual Meeting, showing a highly advantageous safety/efficacy balance with a low and mild incidence of CRS[11][42] - Licensee Candid Therapeutics, Inc. has initiated clinical evaluation of GB261 for autoimmune diseases, with the first cohort of patients showing good tolerability, and a subcutaneous formulation has been determined[11][24][42] GB263T (EGFR/cMET/cMET, Trispecific Antibody) GB263T is the world's first EGFR/cMET/cMET trispecific antibody, featuring a highly differentiated design and multiple mechanisms of action. Its Phase I/II clinical trial completed Phase I dose escalation, showing promising efficacy and a favorable safety profile in non-small cell lung cancer patients - GB263T is the world's first EGFR/cMET/cMET trispecific antibody, targeting EGFR and two different cMET epitopes, designed to enhance safety and efficacy[14][43] - Preclinical studies indicated that GB263T effectively blocked EGFR and cMET ligand-induced phosphorylation and demonstrated superior dual inhibition of EGFR and cMET signaling pathways[44] - The GB263T Phase I/II clinical trial completed Phase I dose escalation, with 15 non-small cell lung cancer patients treated, all of whom had previously received third-generation EGFR-TKI and platinum-based chemotherapy[14][44] - Promising efficacy was observed at therapeutic doses, with an ORR of 28.6%, and clear benefits were seen in patients with cMET alterations[14][46] - The safety profile was advantageous, with a low and mild incidence of infusion-related reactions, and no MET-target-related peripheral edema toxicity or venous thrombosis occurred[14][46] Global First-in-Class/Best-in-Class (FIC/BIC) Drug Development The R&D team focuses on developing FIC/BIC potential targets and projects, having completed multiple highly innovative bispecific/multispecific antibody molecules at or near the PCC stage - The Company's R&D focuses on developing targets and projects with FIC/BIC potential[13][45] - Multiple PCC molecules have been developed, all of which are highly innovative bispecific/multispecific antibody projects with the potential to be best-in-class[13][24][45] CMC Quality and Efficiency Optimization The Group's CMC team continuously optimized platform construction, significantly reduced production costs through localization, and enhanced supply chain stability. Simultaneously, it optimized protein expression, purification, and formulation development platforms, and strengthened quality control, effectively addressing industry pain points and providing high-quality stable drugs for clinical research - The Company's CMC team continuously promotes the platform-based construction of internal and external project collaboration workflows, adhering to the "Focus, Optimize" strategy[15][47] - Through localization efforts in cell culture media, chromatography resins, single-use consumables, excipients, etc., production costs are significantly reduced, supply chain stability is enhanced, warehousing costs are decreased, and working capital efficiency is improved[15][49] - Continuously advancing the construction and optimization of molecular developability assessment platforms for rapid protein expression, high-throughput purification, comprehensive characterization, and process applicability evaluation[15][49] - Optimizing quality control and quality research platforms, and promoting the construction of phase-appropriate quality systems and MAH-related quality systems for drugs[15][49] - The CMC team demonstrates industry-leading capabilities in CMC process technology development, drug product release, and stability studies for products such as GB261, GB263T, and GB268[15][49] Other Matters (Change of Principal Place of Business) Effective January 10, 2025, the Company's principal place of business in Hong Kong changed to Room 1920, 19/F, Lee Garden One, 33 Hysan Avenue, Causeway Bay, Hong Kong - The Company's principal place of business in Hong Kong changed to Room 1920, 19/F, Lee Garden One, 33 Hysan Avenue, Causeway Bay, Hong Kong, effective January 10, 2025[48] Product Pipeline Overview The Group presents its robust product pipeline in oncology and autoimmune diseases across China and globally, including approved Lerociclib and GB242, and innovative antibody drugs at various clinical stages Product Pipeline List (As of Announcement Date) | Product | Target/MoA (Reference Drug) | Indication | Category | Commercial Rights | Early Research | Preclinical | IND Enabling | Phase I | Phase II | Phase III | NDA | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Lerociclib (GB491) | CDK4/6+AI/SERD | 1st/2nd-line HR+/HER2- Breast Cancer | New Drug | Asia Pacific, excl. Japan | | | | | | | NDA Approved | | GB261 | CD20/CD3 | Autoimmune Diseases/Non-Hodgkin Lymphoma | New Drug | Global | | | Phase I (2) / Phase I / II Concurrent | | | | | | GB263T | EGFR×c-Met×c-Met | Non-Small Cell Lung Cancer | New Drug | Global | | | | Phase I / II Concurrent | | | | | GB242 (Infliximab) | TNF-α | Autoimmune Diseases | Biosimilar | Global | | | | | | | NDA Approved | | GB268 | PD-1/VEGF/CTLA-4 | Cancer | New Drug | Global | | | | Phase I | | | | | GBD218 | CD3/BCMA/GPRC5D | Multiple Myeloma | New Drug | Global (3) | Early Research | | | | | | | | GBD220 | CD3/CD19/BCMA | Autoimmune Diseases | New Drug | Global (3) | Early Research | | | | | | | - The ongoing internal development of GB226 PD-1 and GB221 has been suspended, pending further evaluation of development strategy and resource allocation[27] - GB261 has been granted an exclusive global license to Candid Therapeutics, Inc. (excluding Mainland China, Hong Kong, Macau, and Taiwan)[28] - The global development, manufacturing, and commercialization rights for GBD218 have been transferred to EOC Pharma[28] Post-Reporting Period Events Post-reporting period, the Group and EOC Pharma signed service and exclusive entrustment agreements for Lerociclib (GB491) and GB268, with GB268's FIH IND application approved by NMPA, while cautioning investors about merger uncertainties - On July 1, 2025, the Group entered into service agreements with EOC Pharma and EOC (Suzhou) for Lerociclib (GB491) and GB268, providing R&D, manufacturing, distribution, and marketing services[53] - On July 14, 2025, the Group exclusively entrusted EOC Pharma and EOC (Suzhou) with the responsibility for applying for and implementing Lerociclib (GB491)'s inclusion in the National Medical Insurance Catalog[53] - On July 17, 2025, GB268's FIH IND application was approved by NMPA[53] - The Company cautions shareholders and potential investors that the completion of the proposed merger is subject to the fulfillment or waiver of conditions precedent, and the Stock Exchange Listing Committee may not approve the new listing application, with uncertainty also surrounding the whitewash waiver[54][55] Business Outlook The Group will continue to focus on FIC and BIC innovative pipelines in global oncology and autoimmune diseases, balancing efficiency and cost through product portfolio optimization and early-stage differentiated R&D platforms. The merger with EOC Pharma is expected to be completed in the second half of 2025, with Lerociclib (GB491)'s medical insurance application and commercial launch anticipated by the end of 2025, alongside active advancement of GB268 clinical trials and international collaborations for GB263T - The Group will further focus on potential global FIC and BIC innovative pipelines in oncology and autoimmune diseases, optimizing and enriching its existing product portfolio[56] - After transitioning to an asset-light model, the Group will continue to focus on advancing key projects in oncology and autoimmune diseases, achieving an effective balance between efficiency and cost[56] - The new listing application for the proposed merger submitted to the Stock Exchange is expected to be completed in the second half of 2025[56] - The application and negotiation for Lerociclib (GB491)'s inclusion in the National Medical Insurance Catalog are expected to be completed by the end of 2025, with commercial launch anticipated before the end of 2025[56] - Actively advancing GB268 FIH clinical trials and proactively pursuing international collaborations based on GB263T's clinical proof-of-concept data[56] Financial Review This section provides a detailed comparison of key income statement items, liquidity, funding sources, and financial ratios, highlighting the Group's financial performance during the reporting period Comparison of Key Income Statement Items During the reporting period, the Group experienced significant revenue growth and substantial reductions in administrative and R&D expenses, leading to a narrower operating loss and loss for the period Key Income Statement Items Comparison (Six Months Ended June 30) | Metric | 2025 (RMB thousand) | 2024 (RMB thousand) | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 32,245 | 14,470 | +122.8 | | Administrative Expenses | (25,113) | (38,548) | -34.8 | | R&D Expenses | (74,559) | (109,682) | -32.0 | | Operating Loss | (65,709) | (139,580) | -52.9 | | Loss for the Period | (54,373) | (135,055) | -59.7 | Revenue Revenue for the reporting period was approximately RMB 32.2 million, a significant increase from RMB 14.5 million in the prior period, primarily due to a licensing and equity agreement with TRC 2004, Inc - Revenue for the reporting period was approximately RMB 32.2 million, compared to approximately RMB 14.5 million for the six months ended June 30, 2024[58] - The increase in revenue was primarily attributable to the licensing and equity agreement with TRC 2004, Inc[58] Cost of Revenue There was no cost of revenue during the reporting period, compared to approximately RMB 0.3 million in the prior corresponding period - There was no cost of revenue during the reporting period, compared to approximately RMB 0.3 million for the six months ended June 30, 2024[59] Administrative Expenses Administrative expenses decreased by 34.8% to approximately RMB 25.1 million from RMB 38.5 million in the prior period, mainly due to reduced employee benefit expenses - Administrative expenses decreased by 34.8% to approximately RMB 25.1 million for the reporting period, from approximately RMB 38.5 million for the six months ended June 30, 2024[60] - The decrease was mainly due to reduced employee benefit expenses[60] Research and Development Expenses R&D expenses decreased by 32.0% to approximately RMB 74.6 million from RMB 109.7 million in the prior period, primarily due to reduced employee benefit expenses for R&D personnel and new drug development and clinical trial costs - R&D expenses decreased by 32.0% to approximately RMB 74.6 million for the reporting period, from approximately RMB 109.7 million for the six months ended June 30, 2024[61] - The decrease was mainly due to (i) reduced employee benefit expenses for R&D personnel; and (ii) reduced new drug development and clinical trial costs[61] R&D Expenses Components Comparison (Six Months Ended June 30) | Component | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | R&D and Clinical Trial Expenses | 35,501 | 52,801 | | Professional and Technical Service Fees | 21,580 | 5,075 | | Employee Benefit Expenses | 8,233 | 29,907 | | Depreciation and Amortization | 4,435 | 5,893 | | Travel and Transportation Expenses | 1,528 | 3,575 | | Raw Materials and Consumables | 78 | 2,490 | | Utilities | – | 56 | | Impairment of Non-current Assets | – | 9,277 | | Others | 3,204 | 608 | | Total | 74,559 | 109,682 | Loss for the Period Loss for the period decreased to approximately RMB 54.4 million from RMB 135.1 million in the prior period, mainly attributable to the aforementioned expense reductions - Loss for the period decreased to approximately RMB 54.4 million for the reporting period, from approximately RMB 135.1 million for the six months ended June 30, 2024[64] Liquidity and Sources of Funds and Borrowings The Group primarily relies on equity financing for liquidity, with cash and bank balances decreasing to approximately RMB 1,009.9 million as of June 30, 2025, mainly due to operating losses - The Group relies on equity financing as its primary source of liquidity[65] - Cash and bank balances decreased from approximately RMB 1,058.8 million as of December 31, 2024, to approximately RMB 1,009.9 million as of June 30, 2025[65] - The decrease in cash and bank balances was primarily due to operating losses during the reporting period[65] Non-HKFRS Measures (Adjusted Loss) The Group uses adjusted loss as a non-HKFRS measure to better assess business performance, with the adjusted loss for the period significantly narrowing to RMB 59.6 million from RMB 130.2 million in the prior period - The Company uses adjusted loss as an additional financial measure to understand and evaluate relevant business performance and operating trends[66] Adjusted Loss Reconciliation (Six Months Ended June 30) | Metric | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | HKFRS Loss | (54,373) | (135,055) | | Add: Share-based Payment Expenses | (5,205) | 4,903 | | Adjusted Loss | (59,578) | (130,152) | Key Financial Ratios As of June 30, 2025, the Group's current and quick ratios decreased, while the debt ratio slightly increased, indicating tighter liquidity but an overall stable financial structure Key Financial Ratios Comparison | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Current Ratio | 4.93 | 8.74 | | Quick Ratio | 4.89 | 8.72 | | Debt Ratio | 0.17 | 0.11 | - The current ratio is calculated by dividing current assets by current liabilities as of the same date[67] - The quick ratio is calculated by dividing current assets less inventories and prepayments by current liabilities as of the same date[68] - The debt ratio is calculated by dividing total liabilities by total assets as of the same date[69] Other Important Information This section covers significant investments, acquisitions, asset pledges, contingent liabilities, foreign exchange risks, employee and remuneration details, corporate governance, and use of global offering proceeds Material Investments The Group did not make or hold any material investments during the reporting period - During the reporting period, the Group did not make or hold any material investments[70] Material Acquisitions and Disposals Excluding the proposed merger, the Group had no material acquisitions or disposals during the reporting period - Excluding the proposed merger, the Group did not have any material acquisitions or disposals of subsidiaries, merged affiliated entities, or associated companies during the reporting period[71] Pledges of Assets As of June 30, 2025, the Group had no pledges of assets - As of June 30, 2025, the Group had no pledges of assets[72] Contingent Liabilities The Group is involved in a lawsuit for RMB 15 million, but directors believe a valid defense can be raised, thus no provision was made; there were no other material contingent liabilities as of June 30, 2025 - Jiahe Biotech Pharmaceutical, an indirect wholly-owned subsidiary of the Company, is involved in a lawsuit filed by Shanghai New Concept Biomedical Technology Co., Ltd., with a claim amount of RMB 15 million[73] - Based on legal counsel's advice, the directors believe that Jiahe Biotech Pharmaceutical can raise a valid defense against the claim, and no provision has been made[73] - As of June 30, 2025, the Group had no other material contingent liabilities[73] Foreign Exchange Risk The Group primarily operates in RMB, with most transactions settled in RMB; a 10% depreciation or appreciation of RMB against USD would decrease or increase the loss for the period by approximately RMB 99.1 million - The Group conducts its business in China, with most transactions settled in RMB, and its presentation and functional currency is RMB[74] - As of June 30, 2025, if the RMB had depreciated or appreciated by 10% against the USD, the loss for the reporting period would have decreased or increased by approximately RMB 99,056,000[74] - During the reporting period, the Group did not use any derivative contracts to hedge its currency risk exposure[74] Employees and Remuneration As of June 30, 2025, the Group had 17 employees in Shanghai, with total remuneration costs of approximately RMB 10.9 million, a significant decrease from the prior period. The Group complies with all statutory social security funds and housing provident fund obligations, and has employee share option and restricted share unit schemes to incentivize staff - As of June 30, 2025, the Group had a total of 17 employees in Shanghai (December 31, 2024: 24 employees)[75] - Total remuneration costs incurred by the Group during the reporting period were approximately RMB 10.9 million, compared to approximately RMB 53.0 million for the six months ended June 30, 2024[75] - The Company has adopted pre-IPO/post-IPO share option schemes, 2021/2023 restricted share unit schemes, and a 2023 share option scheme to incentivize eligible participants[76] - During the reporting period, the Group had no material labor disputes or difficulties in recruiting employees[78] Corporate Governance The Company is committed to maintaining high standards of corporate governance, complying with the Corporate Governance Code and Model Code for Securities Transactions by Directors during the reporting period - The Board of Directors is committed to achieving high standards of corporate governance to protect shareholders' interests and enhance corporate value and accountability[79] Compliance with Corporate Governance Code The Company adopted and complied with all code provisions of the Corporate Governance Code as set out in Appendix C1 Part 2 of the Listing Rules during the reporting period - The Company has adopted the Corporate Governance Code as set out in Appendix C1 Part 2 of the Listing Rules and complied with all code provisions during the reporting period[80][81] Directors' Compliance with Model Code for Securities Transactions The Company adopted the Model Code for Securities Transactions by Directors of Listed Issuers as set out in Appendix C3 of the Listing Rules, and all directors complied with it during the reporting period - The Company has adopted the Model Code for Securities Transactions by Directors of Listed Issuers as set out in Appendix C3 of the Listing Rules[82] - All directors have complied with the required standards set out in the Model Code throughout the reporting period[82] Audit Committee The Audit Committee, comprising three directors, reviewed the Group's unaudited interim condensed consolidated financial information and this announcement for the six months ended June 30, 2025 - The Audit Committee comprises three directors, with Mr. Fung Koon Ho as Chairman[83] - The Audit Committee has reviewed the Group's unaudited interim condensed consolidated financial information and this announcement for the six months ended June 30, 2025[83] - The Company's independent auditor, Ernst & Young, has reviewed the Group's unaudited interim financial information for the six months ended June 30, 2025[83] Purchase, Sale or Redemption of the Company's Listed Securities Neither the Company nor its subsidiaries purchased, sold, or redeemed any of the Company's listed securities during the reporting period, and no treasury shares were held as of June 30, 2025 - During the reporting period, neither the Company nor any of its subsidiaries purchased, sold, or redeemed any of the Company's listed securities[84] - As of June 30, 2025, the Company did not hold any treasury shares[84] Material Litigation Except for the litigation disclosed in the "Contingent Liabilities" section, the Company was not involved in any other material litigation or arbitration during the reporting period or up to the date of this announcement - Except as disclosed in the "Contingent Liabilities" section, the Company was not involved in any material litigation or arbitration during the reporting period or up to the date of this announcement[85] Use of Net Proceeds from Global Offering The Company's global offering raised net proceeds of approximately RMB 2,536 million, with RMB 1,922.3 million utilized as of June 30, 2025, and the remaining RMB 613.7 million expected to be fully utilized by 2025-2026 for R&D, pipeline expansion, and general corporate purposes - The Company raised net proceeds of approximately HKD 2,923 million (approximately RMB 2,536 million) through its global offering[86] - As of June 30, 2025, the Company had utilized RMB 1,922.3 million of the net proceeds[86] - As of June 30, 2025, approximately RMB 613.7 million of the net proceeds remained unutilized and will be allocated and utilized according to the purposes and proportions stated in the 2023 interim results announcement[86] Use of Net Proceeds from Global Offering and Timeline (As of June 30, 2025) | Purpose | Revised Net Proceeds Allocation (RMB million) | Utilized as of June 30, 2025 (RMB million) | Unutilized as of June 30, 2025 (RMB million) | Expected Timeline for Full Utilization of Remaining Unutilized Net Proceeds | | :--- | :--- | :--- | :--- | :--- | | R&D activities for GB491, GB261, and GB263 | 1,329.2 | 925.4 | 403.8 | On or before December 31, 2026 | | Drug pipeline expansion | 253.6 | 120.4 | 133.2 | On or before December 31, 2026 | | Clinical trials for GB226, GB242, and other drug candidates | 699.6 | 669.1 | 30.5 | On or before December 31, 2026 | | General corporate purposes | 253.6 | 207.4 | 46.2 | On or before December 31, 2025 | | Total | 2,536.0 | 1,922.3 | 613.7 | | Net Proceeds Breakdown by Stage and Utilization (As of June 30, 2025) | Product | Preclinical (RMB million) | Clinical (RMB million) | Commercialization (incl. Registration) (RMB million) | Utilized as of June 30, 2025 (RMB million) | Unutilized as of June 30, 2025 (RMB million) | | :--- | :--- | :--- | :--- | :--- | :--- | | GB491 | – | 736.4 | 100 | 700.8 | 135.6 | | GB261 | 55.8 | 277.1 | – | 153.0 | 179.9 | | GB263 | 45.8 | 114.1 | – | 71.6 | 88.3 | | GB242, GB226, GB492, and other products | 23.9 | 549.7 | 126 | 669.1 | 30.5 | | Total | | | | 1,594.5 | 434.3 | Consolidated Financial Statements This section presents the Group's interim condensed consolidated income statement, statement of comprehensive income, and statement of financial position for the reporting period Interim Condensed Consolidated Statement of Profit or Loss For the six months ended June 30, 2025, the Group recorded a loss for the period of RMB 54,373 thousand, a significant reduction from RMB 135,055 thousand in the prior period, driven by revenue growth and expense control Interim Condensed Consolidated Statement of Profit or Loss (Six Months Ended June 30) | Metric | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Revenue | 32,245 | 14,470 | | Gross Profit | 32,245 | 14,121 | | Administrative Expenses | (25,113) | (38,548) | | R&D Expenses | (74,559) | (109,682) | | Operating Loss | (65,709) | (139,580) | | Net Finance Income | 15,702 | 3,244 | | Loss Before Tax | (50,007) | (136,336) | | Income Tax Income / (Expense) | (4,366) | 1,281 | | Loss for the Period | (54,373) | (135,055) | | Basic Loss Per Share Attributable to Ordinary Equity Holders of the Parent (RMB) | (0.10) | (0.26) | Interim Condensed Consolidated Statement of Comprehensive Income For the six months ended June 30, 2025, the Group's total comprehensive loss for the period was RMB 54,346 thousand, a significant decrease from RMB 141,038 thousand in the prior period, reflecting the narrower loss for the period Interim Condensed Consolidated Statement of Comprehensive Income (Six Months Ended June 30) | Metric | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Loss for the Period | (54,373) | (135,055) | | Exchange differences: Exchange differences on translation of foreign operations | (85) | (5,983) | | Equity investments designated at fair value through other comprehensive income: Fair value changes | 112 | – | | Other comprehensive income / (loss) for the period, net of tax | 27 | (5,983) | | Total Comprehensive Loss for the Period | (54,346) | (141,038) | Interim Condensed Consolidated Statement of Financial Position As of June 30, 2025, the Group's total net assets were RMB 1,098,708 thousand, a decrease from December 31, 2024, with a notable increase in intangible assets and a decrease in cash and bank balances Interim Condensed Consolidated Statement of Financial Position (As of June 30) | Metric | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Non-current Assets | | | | Intangible Assets | 168,658 | 100,466 | | Total Non-current Assets | 287,692 | 222,435 | | Current Assets | | | | Cash and Bank Balances | 1,009,907 | 1,058,790 | | Total Current Assets | 1,037,106 | 1,067,293 | | Current Liabilities | | | | Trade Payables | 172,128 | 82,825 | | Total Current Liabilities | 210,551 | 122,086 | | Non-current Liabilities | | | | Total Non-current Liabilities | 15,539 | 15,963 | | Net Assets | 1,098,708 | 1,151,679 | | Total Equity | 1,098,708 | 1,151,679 | Notes to the Consolidated Financial Statements This section provides detailed notes on the Group's general information, basis of preparation, changes in accounting policies, restatement of comparative amounts, revenue, income tax, loss per share, dividends, and trade payables General Information The Company and its subsidiaries primarily engage in the development and commercialization of oncology and autoimmune disease drugs in China, with financial statements presented in RMB - The Group primarily engages in the development and commercialization of oncology and autoimmune disease drugs in the People's Republic of China ("China")[97] - The financial statements are presented in Renminbi ("RMB")[98] Basis of Preparation The interim condensed consolidated financial information is prepared in accordance with HKAS 34 Interim Financial Reporting and should be read in conjunction with the Group's annual consolidated financial statements for the year ended December 31, 2024 - The interim condensed consolidated financial information has been prepared in accordance with Hong Kong Accounting Standard 34 Interim Financial Reporting[99] - It should be read in conjunction with the Group's annual consolidated financial statements for the year ended December 31, 2024[99] Changes in Accounting Policies and Disclosures The accounting policies used for the interim financial information are consistent with the annual consolidated financial statements, except for the initial adoption of amended HKFRS accounting standards, which had no significant impact - The accounting policies adopted in preparing the interim condensed consolidated financial information are consistent with those applied in the preparation of the Group's annual consolidated financial statements for the year ended December 31, 2024, except for the initial adoption of amended HKFRS accounting standards[100] - The amendments to HKAS 21: Lack of Exchangeability had no impact on the interim condensed consolidated financial information[101] Restatement of Comparative Amounts Due to the discovery of alleged misappropriation of funds by a former employee in late 2024, resulting in a net loss of RMB 8,944,000, the Group has restated its comparative interim condensed consolidated financial statements for the six months ended June 30, 2024 - The Group discovered in late 2024 that a former employee allegedly misappropriated funds, resulting in a net loss of RMB 8,944,000[102] - The directors have restated the comparative interim condensed consolidated financial statements for the six months ended June 30, 2024[102] - As of June 30, 2024, the misappropriated and irrecoverable assets amounted to RMB 9,628,000[102] Revenue License revenue for the reporting period was RMB 32,245 thousand, a significant increase from RMB 14,470 thousand in the prior corresponding period Revenue Components (Six Months Ended June 30) | Revenue Type | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | License Revenue | 32,245 | 14,470 | Income Tax Credit The total income tax expense for the reporting period was RMB 4,366 thousand, compared to an income tax credit of RMB 1,281 thousand in the prior corresponding period Income Tax Components (Six Months Ended June 30) | Component | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Current - Other locations | 5,056 | – | | Deferred | (690) | (1,281) | | Total Tax Expense / (Credit) for the Period | 4,366 | (1,281) | Loss Per Share For the six months ended June 30, 2025, both basic and diluted loss per share attributable to ordinary equity holders of the parent company were RMB 0.10, a significant reduction from RMB 0.26 in the prior period Loss Per Share Calculation (Six Months Ended June 30) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Loss attributable to ordinary equity holders of the parent (RMB thousand) | (54,266) | (134,465) | | Weighted average number of ordinary shares in issue for basic earnings per share calculation | 521,205,520 | 509,677,651 | | Basic Loss Per Share (RMB) | (0.10) | (0.26) | | Diluted Loss Per Share (RMB) | (0.10) | (0.26) | - As the Group recorded a loss for the six months ended June 30, 2025, potential dilutive shares had an anti-dilutive effect on loss per share, thus diluted loss per share was similar to basic loss per share[104] Dividends The Company neither paid nor declared any dividends for the periods ended June 30, 2025, and 2024 - For the periods ended June 30, 2025, and 2024, the Company neither paid nor declared any dividends[107] Trade Payables As of June 30, 2025, total trade payables amounted to RMB 172,128 thousand, with most due within one year, representing a significant increase from RMB 82,825 thousand at the end of 2024 Trade Payables Aging Analysis | Aging | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Within 1 year | 165,469 | 79,826 | | Over 1 year | 6,659 | 2,999 | | Total | 172,128 | 82,825 | - Due to their short-term nature, the carrying amounts approximate their fair values[108]