创胜集团(06628) - 2025 - 中期财报

Company Information Board of Directors and Committees The company's board comprises executive, non-executive, and independent non-executive directors, supported by audit, remuneration, and nomination committees to ensure robust corporate governance - Board members include executive directors such as Dr. Qian Xueming (CEO and Chairman), non-executive directors like Dr. Xu Li, and independent non-executive directors such as Mr. Tang Jiasong[5] - The Audit Committee is chaired by Mr. Tang Jiasong, the Remuneration Committee by Dr. Kumar Srinivasan, and the Nomination Committee by Mr. Zhang Zhihua[5] Key Contact Information The company disclosed key contact information including its registered office, headquarters, Hong Kong principal place of business, legal advisors, auditors, compliance advisor, share registrar, and principal bankers - The company's registered office is in the Cayman Islands, headquarters in Suzhou, China, and principal place of business in Hong Kong is at Lee Garden One, Causeway Bay[5][6] - The auditor is Deloitte Touche Tohmatsu, and legal advisors include Skadden, Arps, Slate, Meagher & Flom (Hong Kong and U.S. law) and Zhong Lun Law Firm (PRC law)[5][6] - Principal bankers are The Hongkong and Shanghai Banking Corporation Limited and China Construction Bank, Suzhou Branch[7] Financial Summary IFRS Measures For the six months ended June 30, 2025, revenue decreased due to reduced CDMO services, while other income rose from increased government grants, leading to a significant narrowing of loss and total comprehensive expense for the period 2025 H1 Key Financial Indicators (IFRS) | Indicator | 2025 H1 (RMB million) | 2024 H1 (RMB million) | Change (RMB million) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | 2.7 | 4.6 | (1.9) | Decrease in CDMO services | | Other Income | 11.4 | 9.6 | 1.8 | Increase in government grants | | Other Gains and Losses | (1.2) (Loss) | 1.0 (Gain) | (2.2) | Difference in net exchange gains | | Research and Development Expenses | 76.7 | 103.0 | (26.3) | Pipeline advancement and resource prioritization | | Administrative and Selling Expenses | 28.3 | 31.4 | (3.1) | Decrease in share-based compensation | | Loss and Total Comprehensive Expense for the Period | 108.8 | 135.2 | (26.4) | Decrease in R&D investment | Non-IFRS Measures Excluding share-based compensation expenses, the company's adjusted loss and total comprehensive expense also significantly decreased, primarily due to optimized R&D investment and reduced labor costs 2025 H1 Adjusted Financial Indicators (Non-IFRS) | Indicator | 2025 H1 (RMB million) | 2024 H1 (RMB million) | Change (RMB million) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | 2.7 | 4.6 | (1.9) | Decrease in CDMO services | | Other Income | 11.4 | 9.6 | 1.8 | Increase in government grants | | R&D Expenses (excluding share-based payments) | 70.8 | 95.5 | (24.7) | Reduced pipeline investment and resource optimization | | Administrative and Selling Expenses (excluding share-based payments) | 24.9 | 26.1 | (1.2) | Decrease in labor costs and professional services | | Adjusted Loss and Total Comprehensive Expense for the Period | 99.4 | 122.4 | (23.0) | Decrease in pipeline advancement related R&D investment | Business Summary Clinical Program Achievements The company achieved significant clinical progress in both oncology and non-oncology pipelines, with Osemitamab (TST001) showing encouraging Phase II data in gastric cancer and securing multi-country regulatory approvals and patents for global Phase III trials, while early-stage oncology pipelines TST105 and TST013, and non-oncology pipelines TST801 and TST808 also advanced - Osemitamab (TST001) demonstrated a median progression-free survival (mPFS) of 16.6 months and a median overall survival (mOS) of 21.7 months in a Phase II trial for first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma[12][18] - Osemitamab (TST001) has received regulatory approvals from the US FDA, China CDE, and Korea MFDS, and patents in China, Russia, and Hong Kong, supporting the global Phase III trial (TranStar301)[12][18] - TST105 (anti-FGFR2b ADC) showed significantly higher tumor regression activity than MMAE-based ADCs in preclinical gastric and colorectal cancer models[13][19] - TST013 (anti-LIV-1 ADC) demonstrated significantly improved anti-tumor activity and good tolerability in animal models, initiating preparatory studies to support IND filing[20] - TST801 (bispecific antibody) exhibited best-in-class properties in a humanized lupus nephritis mouse model, holding promise for treating various autoimmune diseases[21] - TST808 (humanized antibody) has improved properties in blocking B cell proliferation and signaling, with an extended half-life, potentially treating various autoimmune kidney diseases like IgAN[22] Business Development Achievements The company actively advanced clinical trial collaborations with BMS and Agilent, sought partners for global development and commercialization of Osemitamab (TST001) and other pipeline assets, made progress in technology transfer and strategic alliances, and expanded its CDMO services - Continued collaboration with BMS on the China TranStar102 trial and US TranStar101 trial for Osemitamab (TST001) in combination with checkpoint inhibitors and chemotherapy[24] - Advanced collaboration with Agilent to develop a Claudin18.2-specific immunohistochemistry CDx assay kit to support the global Phase III pivotal trial of Osemitamab (TST001)[24] - Actively engaged potential partners for global and regional development and commercialization of Osemitamab (TST001), having received multiple term sheets[24] - Signed a non-binding term sheet with an independent third-party licensee for the licensing and technology transfer of proprietary HiCB platform technology and intellectual property[24] - Strengthened alliance with siRNA API synthesis companies to provide CDMO services for siRNA drug preparation and filling processes[24] CMC and CDMO Progress The company made progress in CMC (Chemistry, Manufacturing, and Control), successfully held an FDA Type C meeting, and continuously upgraded its cell line expression system and media products, while expanding its CDMO service scope - Successfully held an FDA Type C meeting, reaching agreement on comparability strategies and plans for the integrated hybrid continuous downstream process for commercial supply production of Osemitamab (TST001)[25] - Continuously upgraded internal cell line expression systems and established perfusion, basal, and feed media for commercialization readiness[27] - Expanded siRNA drug development service scope and increased international market exposure; expanded services to clients requiring lyophilized drug products[27] Management Discussion and Analysis Overview The company is a clinical-stage biopharmaceutical firm with integrated discovery, research, development, and manufacturing capabilities, focusing on oncology, osteoporosis, nephrology, and autoimmune diseases, implementing a multi-regional development strategy and leveraging proprietary platforms and CMC capabilities to generate revenue through CDMO services - The company has received approvals from the US FDA, China CDE, and Korea MFDS to initiate a global Phase III trial for Osemitamab (TST001) in combination with checkpoint inhibitors and chemotherapy as a first-line treatment for Claudin18.2-expressing locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma patients[29] - The company possesses proprietary antibody discovery platforms, comprehensive CMC capabilities, advanced translational science platforms, and HiCB manufacturing platform technology, supporting drug development and providing CDMO services[30] - The company pursues a global strategy, establishing partnerships with domestic and international biopharmaceutical companies and academic institutions, and exploring innovative transaction structures like forming new companies to accelerate market entry and maximize asset value[30] Product Pipeline The company has established a diverse and differentiated pipeline of 16 molecules covering multiple therapeutic areas including oncology, bone disorders, and nephrology, with most developed in-house and including best-in-class or first-in-class drugs Company Product Pipeline Overview | Area | Candidate Drug | Target | Modality | Indication | Clinical Stage | Rights | Partner | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Oncology | Osemitamab (TST001) | Claudin18.2 | mAb | G/GEJC 1st line | Pivotal Phase III | Global | In-house | | Oncology | TST003 | Gremlin-1 (FIC) | mAb | Solid Tumors | Phase I | Global | In-house | | Oncology | TST786 | PD1-VEGF & Gremlin-1 (FIC) | Trispecific Antibody | Solid Tumors | Preclinical | Global | In-house | | Oncology | TST105 | FGFR2b Bi-Specific | ADC | Solid Tumors | Preclinical | Global | In-house | | Oncology | TST013 | LIV-1 | ADC | Solid Tumors | Preclinical | Global | In-house | | Non-Oncology | Blosozumab (TST002) | Sclerostin | mAb | Osteoporosis | Phase II (US completed) | Greater China | Eli Lilly | | Non-Oncology | TST801 | BAFF/APRIL (FIC) | BsP | Autoimmune Diseases | Preclinical | Global | In-house | | Non-Oncology | TST808 | Anti-APRIL | mAb | IgAN | Preclinical | Global | In-house | - The pipeline includes five best-in-class molecules (TST001, TST002, TST004, TST801, and TST808) and three first-in-class molecules (TST003, TST786, and TST008)[33] Business Review The company achieved significant progress in both oncology and non-oncology pipeline assets, with multiple clinical and preclinical projects reaching milestones, notably Osemitamab (TST001) performing well in gastric cancer treatment, and actively advancing other innovative drug developments Oncology Programs The company's oncology pipeline encompasses various innovative biomolecules aimed at addressing significant unmet medical needs, with Osemitamab (TST001) as a key project showing potential superiority over competing molecules in Claudin18.2-positive gastric cancer treatment and having received multi-country approvals for global Phase III trials, while other projects like MSB0254, TST003, TST786, TST012, TST105, and TST013 also made preclinical or early clinical progress - Osemitamab (TST001) is a potentially best-in-class antibody targeting Claudin18.2, approved by the US FDA, China CDE, and Korea MFDS to initiate a global Phase III registration trial (TranStar301)[34] - Osemitamab (TST001) exhibits higher affinity and stronger ADCC compared to competing molecules, with preliminary clinical data suggesting its potential to benefit a broader patient population (approximately 55% of gastric or gastroesophageal junction adenocarcinoma patients)[36] - TST105 (FGFR2b-targeting bispecific ADC) presented preclinical study results at the AACR annual meeting, demonstrating significantly enhanced anti-tumor activity[19][47] - TST013 (LIV-1-targeting ADC) showed encouraging anti-tumor activity data in animal models and initiated preparatory studies for IND filing[20][48] Non-Oncology Programs The company's non-oncology pipeline focuses on bone and kidney diseases, including blosozumab (TST002), TST004, TST008, TST801, and TST808, with blosozumab (TST002) showing positive bone mineral density increase in a China Phase II trial, and TST801 and TST808 demonstrating best-in-class potential in autoimmune diseases and entering preclinical stages - Blosozumab (TST002) showed an average increase in lumbar spine BMD of 3.52% to 6.20% and total hip BMD of 1.30% to 2.24% after a single dose in Chinese subjects, consistent with US patient clinical data[50] - TST801 (first-in-class bifunctional antibody fusion protein) demonstrated best-in-class properties in a humanized lupus nephritis mouse model, reducing memory B cells, dsDNA, IgA, IgM, and IgG, as well as lowering proteinuria and renal damage scores[54] - TST808 (humanized antibody) has improved properties in blocking B cell proliferation and signaling, with an extended half-life, holding potential for treating various autoimmune kidney diseases like IgAN[55] Strategic Collaborations to Advance Pipeline The company actively advances pipeline development and commercialization through clinical trial collaborations with BMS, Eli Lilly, and Livzon Pharmaceutical, as well as research collaborations with academic institutions and technology platform companies, and is seeking global and regional partners for multiple core assets - Established a global clinical trial collaboration with Bristol Myers Squibb (BMS) to evaluate the efficacy of Osemitamab (TST001) in combination with Opdivo® (nivolumab) for Claudin18.2-expressing gastric or gastroesophageal junction adenocarcinoma[59] - Entered into an exclusive license agreement with Eli Lilly for the development and commercialization of blosozumab (TST002) in Greater China[62] - Formed a joint venture with Shanghai Livzon Pharmaceutical Technology Co., Ltd. to conduct preclinical and clinical trials for TST004 in Greater China[65] - Actively exploring collaboration opportunities with potential partners for pipeline assets including Osemitamab (TST001), blosozumab (TST002), TST003, TST004, TST801, TST808, TST008, TST105, and TST013[61][64][66][67][68][69][70][71] - Established multiple translational research collaborations with renowned academic institutions such as Dana-Farber Cancer Institute at Harvard Medical School, Johns Hopkins University, and Peking University Cancer Hospital[72] Technology Collaborations and Progress The company achieved significant progress in CMC delivery, platform and technology development, and CDMO business, successfully reaching an agreement with the FDA on the commercial supply production process for Osemitamab (TST001), and actively promoting the out-licensing of proprietary technology platforms and commercialization of cell culture media - Successfully held an FDA Type C meeting, reaching agreement on comparability strategies and plans for the integrated hybrid continuous downstream process for commercial supply production of Osemitamab (TST001)[74] - Entered into a non-binding term sheet with an independent third-party licensee to grant a non-exclusive license for proprietary HiCB platform technology and intellectual property[76] - Internal cell culture medium ExcelPro CHO is undergoing evaluation by multiple external partners, offering opportunities for potential global commercialization collaborations[76] - Continuously improved internal cell line expression systems and established media for perfusion and fed-batch processes, ready for commercialization[77] - Expanded siRNA drug development service scope and lyophilized drug product services, actively attracting new clients[84] Future Outlook The company anticipates advancing multiple key investigational molecules and continuing to seek collaborations to support its global development strategy, with a future focus on strengthening products and technology platforms, improving efficiency, and reducing expenses to achieve sustainable value growth - Plans to continue advancing the global pivotal trial (TranStar301) for Osemitamab (TST001) and submit applications to regulatory agencies in regions such as the EMA and Japan[85] - Collaborations with potential partners are expected to drive Osemitamab (TST001) into global Phase III trials for first-line CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma[87] - Will continue to explore collaborations for blosozumab (TST002), TST003, TST004, and preclinical assets (e.g., TST105, TST012, TST013, TST008, TST801, and TST808) to maximize asset value[87] - Committed to strengthening marketing initiatives for the HiCB continuous technology platform, cell culture media products, and development services, and enhancing and expanding CDMO business development activities globally[87] Financial Review For the six months ended June 30, 2025, the company's revenue decreased, but losses narrowed, primarily due to reduced R&D and administrative expenses; net current liabilities increased, and the debt-to-asset ratio rose, indicating increased liquidity pressure, while the company continued to monitor foreign exchange risks and manage funds through bank borrowings Condensed Consolidated Income Statement Excerpts (Six Months Ended June 30) | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Revenue | 2,711 | 4,564 | | Gross Profit | 791 | 1,524 | | Other Income | 11,366 | 9,570 | | Research and Development Expenses | (76,731) | (102,965) | | Administrative and Selling Expenses | (28,291) | (31,440) | | Loss for the Period | (109,785) | (133,722) | | Total Comprehensive Expense for the Period | (108,784) | (135,185) | | Adjusted Loss and Total Comprehensive Expense for the Period | (99,445) | (122,361) | Financial Position Statement Excerpts | Indicator | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Total Assets | 1,038,700 | 1,200,277 | | Total Liabilities | 386,566 | 448,641 | | Net Current Liabilities | (146,480) | (63,013) | Revenue Breakdown (Six Months Ended June 30) | Service Category | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | CDMO Services | 2,167 | 4,564 | | R&D Services | 544 | – | | Total | 2,711 | 4,564 | - Other income increased by RMB 1.8 million to RMB 11.4 million, primarily due to increased government grants[94] - Research and development expenses decreased by RMB 26.3 million to RMB 76.7 million, mainly due to reduced investment in advancing key pipelines and optimized resource reallocation[96] - Administrative and selling expenses decreased by RMB 3.1 million to RMB 28.3 million, primarily due to reduced labor costs and professional services[99] - Bank balances and cash decreased from RMB 227.4 million as of December 31, 2024, to RMB 101.1 million as of June 30, 2025, mainly due to operating cash outflows[108] - The debt-to-asset ratio increased from 0.76% as of December 31, 2024, to 14.24% as of June 30, 2025[110] Going Concern Issues and Mitigation Plans The independent auditor issued a disclaimer of opinion on the condensed consolidated financial statements, primarily based on the company's loss, operating cash outflow, and net current liabilities for the six months ended June 30, 2025; management and the board have assessed and formulated multiple mitigation plans, including seeking external collaborations, financing, technology licensing, and optimizing resource allocation, to address significant going concern doubts - For the six months ended June 30, 2025, the company incurred a net loss of RMB 109,785,000, net operating cash outflow of RMB 75,705,000, and net current liabilities of approximately RMB 146,480,000, raising significant doubts about its ability to continue as a going concern[133][207] - The company is actively negotiating with third parties to advance the global development and commercialization of key pipelines through "out-licensing" and/or "co-development programs," and has received multiple term sheets[124][207] - The company has engaged in discussions and negotiations with various parties for capital financing, including new share issuance, PIPE, or convertible bond issuance, and plans to arrange and execute these within the year[126][207] - The company has secured bank financing and established strategic collaborations with several banks, obtaining credit facilities exceeding RMB 100 million to support daily operations and new drug development[129][207] - The Audit Committee reviewed and concurred with the Board's assessment regarding the adoption of the going concern assumption, believing that the mitigation plans (if effectively executed) will help address liquidity burdens[132] Other Information Directors' and Chief Executive's Interests As of June 30, 2025, the company's directors and chief executive held interests in the company's shares and related shares, with Dr. Qian Xueming holding approximately 8.67% and Dr. Xu Li holding approximately 1.02% Directors' and Chief Executive's Interests in Shares (As of June 30, 2025) | Director Name | Capacity/Nature of Interest | Number of Ordinary Shares | Approximate Percentage of Shareholding | | :--- | :--- | :--- | :--- | | Dr. Qian Xueming | Beneficial owner, founder and beneficiary of discretionary trust, interest in controlled corporation | 37,926,000 | 8.67% | | Dr. Xu Li | Beneficial owner | 4,461,501 | 1.02% | | Mr. Tang Jiasong | Beneficial owner | 60,000 | 0.01% | | Mr. Zhang Zhihua | Beneficial owner | 60,000 | 0.01% | | Dr. Kumar Srinivasan | Beneficial owner | 30,000 | 0.01% | | Ms. Chen Wei | Beneficial owner | 30,000 | 0.01% | Major Shareholders' Interests As of June 30, 2025, the company's major shareholders included HSBC Trust Company (Delaware) National Association, Yi Shi and entities controlled by him, Temasek Holdings (Private) Limited and entities controlled by it, and China Structural Reform Fund Corporation Limited, holding significant interests in the company's shares or related shares Major Shareholders' Interests in Shares (As of June 30, 2025) | Shareholder Name/Name | Capacity/Nature of Interest | Number of Ordinary Shares | Approximate Percentage of Shareholding | | :--- | :--- | :--- | :--- | | Dr. Qian Xueming | Beneficial owner; founder and beneficiary of discretionary trust; interest in controlled corporation | 37,926,000 | 8.67% | | HSBC Trust Company (Delaware) National Association | Trustee of discretionary trust | 45,653,530 | 10.44% | | Yi Shi | Interest in controlled corporation | 70,536,703 | 16.13% | | LAV Asset Management (Hong Kong) Limited | Investment manager | 70,536,703 | 16.13% | | LAV Corporate GP, Ltd. | Interest in controlled corporation | 50,566,136 | 11.56% | | LAV GP III, L.P. | Interest in controlled corporation | 50,566,136 | 11.56% | | LAV Biosciences Fund III, L.P. | Beneficial owner; interest in controlled corporation | 33,710,963 | 7.71% | | LAV Vitality Limited | Beneficial owner | 22,388,232 | 5.12% | | Temasek Holdings (Private) Limited | Interest in controlled corporation | 28,086,380 | 6.42% | | Fullerton Management Pte Ltd | Interest in controlled corporation | 26,021,880 | 5.95% | | Temasek Life Sciences Private Limited | Interest in controlled corporation | 26,021,880 | 5.95% | | TLS Beta Pte. Ltd. | Beneficial owner | 26,021,880 | 5.95% | | China Structural Reform Fund Corporation Limited | Beneficial owner; interest in controlled corporation | 39,421,012 | 9.01% | | Xiaohong Shi | Beneficial owner | 22,411,376 | 5.12% | Equity Incentive Plans The company has a Pre-IPO Share Incentive Scheme (terminated but unexercised portions remain valid) and a Share Incentive Scheme, designed to incentivize employees, directors, senior management, and consultants; as of June 30, 2025, a significant number of share options and restricted share units under both schemes remained unexercised or unvested - The Pre-IPO Share Incentive Scheme was terminated on May 31, 2023, but unexercised share options and granted restricted share units remain valid[151] Pre-IPO Share Option Movements (As of June 30, 2025) | Category | Unexercised as of January 1, 2025 | Exercised during the Period | Lapsed during the Period | Unexercised as of June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | | Directors (Dr. Xu Li) | 2,200,000 | – | – | 2,200,000 | | Other Employee Participants | 8,349,260 | 49,500 | 5,000 | 8,294,760 | | Service Providers | 680,000 | – | – | 680,000 | | Total | 11,229,260 | 49,500 | 5,000 | 11,174,760 | Pre-IPO Restricted Share Unit Movements (As of June 30, 2025) | Category | Unvested as of January 1, 2025 | Vested during the Period | Lapsed during the Period | Unvested as of June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | | Employee Participant (1) | 1,850,000 | 354,166 | 1,495,834 | – | | Employee Participants (17) | 630,000 | 132,500 | – | 497,500 | | Total | 2,480,000 | 486,666 | 1,495,834 | 497,500 | - The Share Incentive Scheme limit is 44,551,933 shares, with 3,897,844 awards or share options available for future grants as of June 30, 2025[163] Share Incentive Scheme Share Option Movements (As of June 30, 2025) | Category | Unexercised as of January 1, 2025 | Granted during the Period | Lapsed during the Period | Unexercised as of June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | | Directors, Chief Executive, or Major Shareholders | 4,933,000 | – | – | 4,933,000 | | Other Employee Participants | 13,364,330 | – | – | 13,364,330 | | Service Providers | – | 2,000,000 | – | 2,000,000 | | Total | 18,297,330 | 2,000,000 | 0 | 20,297,330 | Share Incentive Scheme Award Movements (As of June 30, 2025) | Category | Unvested as of January 1, 2025 | Granted during the Period | Vested during the Period | Lapsed during the Period | Unvested as of June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Directors, Chief Executive, or Major Shareholders | 4,928,828 | 90,000 | 160,000 | – | 4,858,828 | | Senior Management | 3,405,620 | – | – | 3,905,620 | – | | Other Employee Participants | 6,367,360 | 676,000 | 3,557,210 | 374,440 | 3,111,710 | | Total | 14,701,794 | 766,000 | 3,717,210 | 4,280,060 | 7,470,524 | Purchases, Sales or Redemptions of the Company's Listed Securities During the reporting period, the company repurchased 166,500 ordinary shares for a total consideration of approximately HKD 99,959.45, aiming to enhance share value; the repurchased shares are held as treasury shares, available for share grants, resale, or other permitted uses Share Repurchase Details (January 2025) | Month of Repurchase | Number of Shares Repurchased | Highest Price Paid Per Share (HKD) | Lowest Price Paid Per Share (HKD) | Total Consideration (HKD) | | :--- | :--- | :--- | :--- | :--- | | January 2025 | 166,500 | 0.6100 | 0.5800 | 99,959.45 | | Total | 166,500 | – | – | 99,959.45 | - As of June 30, 2025, the company held 2,516,500 treasury shares, available for share grants, resale to raise funds, and other permitted uses[174] Material Litigation and Future Plans During the reporting period, the company was not involved in any material litigation or arbitration, nor did it have any other future plans for significant investments or capital assets - During the reporting period, the company was not involved in any material litigation or arbitration, nor were there any pending or threatened material litigations or claims[177] - As of the date of this report, the Group had no other plans regarding significant investments and capital assets[178] Use of Net Proceeds The company has repeatedly adjusted the use of net proceeds from its global offering to prioritize the development of Osemitamab (TST001) and other urgent project needs, aiming to optimize financial resource allocation, maximize potential return on investment, and expects to fully utilize the remaining funds by the end of 2025 - The Board resolved to reallocate approximately HKD 28.8 million of unutilized net proceeds to fund the development of Osemitamab (TST001) and other in-house pipeline products requiring support[182] Updated Allocation of Net Proceeds After Changes (As of June 30, 2025) | Use of Net Proceeds | Amount Utilized as of June 30, 2025 (HKD million) | Proposed Allocation of Remaining Net Proceeds After Changes (HKD million) | Approximate Percentage of Remaining Unutilized Net Proceeds | Expected Timeline for Full Utilization of Unutilized Net Proceeds | | :--- | :--- | :--- | :--- | :--- | | R&D, clinical and preclinical trials, registration filings, and commercialization-related activities for pipeline drug candidates | 467.3 | 30.8 | 100% | On or before December 31, 2025 | | (i) Clinical trials, registration filings, and preparations for potential commercial launch of key product Osemitamab (TST001) | 349.5 | 25.6 | 83.1% | On or before December 31, 2025 | | (ii) Clinical trials, registration filings, and preparations for potential commercial launch of key product TST005 | 12.3 | 2.0 | 6.5% | On or before December 31, 2025 | | (iii) Clinical trials, registration filings, and preparations for potential commercial launch of key product TST002 | 31.1 | – | – | On or before December 31, 2025 | | (iv) Preclinical trials and preparations for registration filings of key products and other pipeline products (TST004, MSB0254, TST003, TST006, and TST008) | 74.5 | 3.2 | 10.4% | On or before December 31, 2025 | | Business development (pipeline expansion and technology development) | – | – | – | On or before December 31, 2025 | | General working capital and general operating expenses | 55.3 | – | – | Not applicable | | Total | 522.7 | 30.8 | 100% | Not applicable | - The changes in the use of net proceeds aim to optimize financial resource allocation to adapt to evolving market conditions and business development priorities, and to maximize the potential return on investment[188] - The company expects to fully utilize the remaining unutilized net proceeds by the end of 2025[189] Corporate Governance and Other Information The company is committed to maintaining stringent corporate governance standards, with established audit, nomination, and remuneration committees; despite the Chairman and CEO roles being held by the same individual, the company believes this arrangement fosters leadership consistency; during the reporting period, the company complied with the Corporate Governance Code and disclosed changes in its Chief Medical Officer - The Audit Committee reviewed the Group's unaudited consolidated financial statements for the six months ended June 30, 2025, and discussed them with the independent auditor and senior management[192] - The Board recommended not to declare an interim dividend for the six months ended June 30, 2025[194] - The company complied with all applicable provisions of the Corporate Governance Code, except for the roles of Chairman and Chief Executive Officer being combined and held by Dr. Qian Xueming, which the company believes promotes leadership consistency[198] - Following Dr. Caroline Germa's resignation as Chief Medical Officer, Dr. Qi Chuan has assumed the responsibilities of Head of Global Clinical Development, with a scope of duties and seniority comparable to that of a Chief Medical Officer[203] Review Report on Condensed Consolidated Financial Statements Basis for Disclaimer of Opinion Independent auditor Deloitte Touche Tohmatsu issued a disclaimer of opinion on the company's condensed consolidated financial statements, primarily due to the company's loss, operating cash outflow, and net current liabilities for the six months ended June 30, 2025, and the validity of the going concern assumption depending on several ongoing plans and measures lacking written contractual agreements or sufficient supporting documentation - For the six months ended June 30, 2025, the company incurred a net loss of RMB 109,785,000, net operating cash outflow of RMB 75,705,000, and net current liabilities of approximately RMB 146,480,000, which raise significant doubts about its ability to continue as a going concern[207] - The validity of the going concern assumption depends on the company's successful implementation of various plans and measures, including advancing global development of key pipelines, seeking out-licensing or fundraising, securing new bank financing, extending existing bank borrowing terms, and extending repayment dates for overdue payables[207] - As the company's plans and measures are ongoing and lack written contractual agreements or other sufficient supporting documentation from relevant counterparties, the auditor was unable to obtain sufficient appropriate audit evidence to assess the likelihood of successful execution of these plans and the appropriateness of the going concern accounting basis[209] - Should the company fail to achieve the combination of these plans and measures, it may be unable to continue operating as a going concern, potentially requiring adjustments to the carrying amounts of assets, which are not reflected in the condensed consolidated financial statements[209] Disclaimer of Opinion Given the significance of the matters described in the "Basis for Disclaimer of Opinion" section, the independent auditor was unable to obtain sufficient and appropriate evidence, and therefore does not express an opinion on the company's condensed consolidated financial statements - The independent auditor does not express an opinion on the company's condensed consolidated financial statements due to the inability to obtain sufficient appropriate evidence to assess the appropriateness of the directors' use of the going concern basis and the adequacy of related disclosures[211] Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income Overview of Profit or Loss and Comprehensive Income For the six months ended June 30, 2025, the company's revenue was RMB 2,711 thousand, with a loss for the period of RMB 109,785 thousand, a narrowing from RMB 133,722 thousand in the prior year, and basic and diluted loss per share was RMB 0.27 Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income (Six Months Ended June 30) | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Revenue | 2,711 | 4,564 | | Gross Profit | 791 | 1,524 | | Other Income | 11,366 | 9,570 | | Research and Development Expenses | (76,731) | (102,965) | | Administrative and Selling Expenses | (28,291) | (31,440) | | Loss Before Tax | (109,907) | (133,847) | | Loss for the Period | (109,785) | (133,722) | | Total Comprehensive Expense for the Period | (108,784) | (135,185) | | Basic and Diluted Loss Per Share (RMB) | (0.27) | (0.33) | Condensed Consolidated Statement of Financial Position Overview of Statement of Financial Position As of June 30, 2025, the company's total assets were RMB 1,038,700 thousand, a decrease from December 31, 2024; net current liabilities expanded to RMB 146,480 thousand, indicating increased liquidity pressure, and net assets stood at RMB 652,134 thousand Condensed Consolidated Statement of Financial Position (As of June 30, 2025) | Indicator | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Non-current Assets | 897,238 | 920,783 | | Current Assets | 141,462 | 279,494 | | Total Assets | 1,038,700 | 1,200,277 | | Current Liabilities | 287,942 | 342,507 | | Non-current Liabilities | 98,624 | 106,134 | | Total Liabilities | 386,566 | 448,641 | | Net Current Liabilities | (146,480) | (63,013) | | Net Assets | 652,134 | 751,636 | Condensed Consolidated Statement of Changes in Equity Overview of Statement of Changes in Equity For the six months ended June 30, 2025, the company's total equity decreased from RMB 751,636 thousand as of January 1, 2025, to RMB 652,134 thousand, primarily due to total comprehensive expense for the period and share repurchases, partially offset by share-based payments Condensed Consolidated Statement of Changes in Equity (Six Months Ended June 30) | Item | January 1, 2025 (RMB thousand) | Total Comprehensive (Expense) Income for the Period (RMB thousand) | Repurchase of Shares (RMB thousand) | Equity-settled Share-based Payments Recognized (RMB thousand) | Exercise of Share Options/Vesting of Restricted Share Units (RMB thousand) | June 30, 2025 (RMB thousand) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Share Capital | 284 | – | – | – | 1 | 285 | | Share Premium | 4,654,387 | – | – | – | 336 | 4,654,723 | | Treasury Shares | (2,371) | – | (93) | – | 3 | (2,462) | | Accumulated Losses | (3,799,411) | (109,785) | – | – | – | (3,909,196) | | Exchange Reserve | (12,990) | 1,001 | – | – | – | (11,989) | | Total Equity | 751,636 | (108,784) | (93) | 9,339 | 36 | 652,134 | Condensed Consolidated Statement of Cash Flows Overview of Statement of Cash Flows For the six months ended June 30, 2025, the company's net cash used in operating activities was RMB 75,705 thousand, and net cash used in financing activities was RMB 44,568 thousand, resulting in a net decrease in cash and cash equivalents of RMB 123,493 thousand Condensed Consolidated Statement of Cash Flows (Six Months Ended June 30) | Category of Activity | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (75,705) | (119,462) | | Net Cash (Used in) Generated from Investing Activities | (3,220) | 2,828 | | Net Cash Used in Financing Activities | (44,568) | (64,878) | | Net Decrease in Cash and Cash Equivalents | (123,493) | (181,512) | | Cash and Cash Equivalents at End of Period | 45,810 | 365,009 | Notes to the Condensed Consolidated Financial Statements Basis of Preparation and Going Concern Assessment The condensed consolidated financial statements are prepared in accordance with IAS 34; the company faces significant going concern doubts due to its losses, operating cash outflows, and net current liabilities; the Board has formulated multiple mitigation plans and believes the company has sufficient financial resources to continue as a going concern, but the auditor issued a disclaimer of opinion due to a lack of sufficient supporting documentation - As of June 30, 2025, the company incurred a net loss of RMB 109,785,000, net operating cash outflow of RMB 75,705,000, and net current liabilities of approximately RMB 146,480,000, posing significant doubts about its ability to continue as a going concern[222] - The company has adopted several mitigation measures, including seeking out-licensing, co-development, capital financing, renewal of bank borrowings, extension of repayment dates for payables, attracting new CDMO clients, and optimizing resource allocation[222] - The Board believes that, considering the aforementioned plans and measures, the company has sufficient financial resources to continue operating in the foreseeable future and has prepared the financial statements on a going concern basis[223] - The auditor noted that due to the ongoing nature of the plans and measures and the lack of written contractual agreements or other sufficient supporting documentation, there is significant uncertainty, preventing a conclusion on the appropriateness of the going concern assumption[224] Accounting Policies and Segment Information The company's condensed consolidated financial statements are prepared on a historical cost basis and first-time application of amendments to IFRS; the chief operating decision maker views the group as a single operating segment, with all external customer revenue and non-current assets located in China - The accounting policies and calculation methods used in the company's condensed consolidated financial statements are consistent with those in the annual consolidated financial statements for the year ended December 31, 2024, with the first-time application of IAS 21 (amended) "Lack of Exchangeability"[226][227] - The company is primarily engaged in the discovery, development, manufacturing, and commercialization of innovative drugs, and the chief operating decision maker views the Group as a single operating segment[231] - All external customer revenue is derived from China, and all non-current assets are located in China[233] Major Customer Revenue (Six Months Ended June 30) | Customer | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Customer A | 1,226 | Not applicable | | Customer B | 373 | – | | Customer C | 308 | Not applicable | | Customer D | – | 1,763 | | Customer E | – | 607 | Other Income and Gains For the six months ended June 30, 2025, the company's other income increased, primarily due to higher government grants, while net other gains and losses shifted from a gain to a loss, mainly impacted by exchange differences Other Income (Six Months Ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Bank Interest Income | 992 | 2,132 | | Government Grants | 9,295 | 7,438 | | Sales of Raw Materials | 1,079 | – | | Total | 11,366 | 9,570 | Net Other Gains and Losses (Six Months Ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Net Exchange (Loss) Gain | (938) | 1,407 | | Others | (254) | (369) | | Total | (1,192) | 1,038 | Loss Before Tax and Loss Per Share For the six months ended June 30, 2025, the company's loss before tax was RMB 109,907 thousand, a narrowing from RMB 133,847 thousand in the prior year, with basic and diluted loss per share at RMB 0.27, and no dividends were paid during the period Components of Loss Before Tax (Six Months Ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Depreciation of Property, Plant and Equipment | 22,913 | 23,911 | | Amortization of Intangible Assets | 44 | 74 | | Depreciation of Right-of-Use Assets | 1,554 | 2,853 | | Auditor's Remuneration | 1,562 | 1,354 | | Directors' Emoluments | 3,589 | 2,743 | | Other Staff Costs | 49,668 | 69,407 | Loss Per Share Calculation (Six Months Ended June 30) | Indicator | 2025 | 2024 | | :--- | :--- | :--- | | Loss for the Period Attributable to Owners of the Company Used for Basic and Diluted Loss Per Share Calculation (RMB thousand) | (109,785) | (133,722) | | Weighted Average Number of Ordinary Shares Used for Basic and Diluted Loss Per Share Calculation | 406,939,951 | 405,633,640 | | Basic and Diluted Loss Per Share (RMB) | (0.27) | (0.33) | - The company did not pay, declare, or propose any dividends during this interim period[239] Impairment Assessment of Assets The company conducted an impairment assessment of goodwill and intangible assets, and given the deferral of R&D expenses, management identified indicators of impairment; the assessment concluded that the estimated recoverable amount of the cash-generating unit exceeded its carrying amount, thus no impairment was recognized, and sensitivity analysis showed that reasonable changes in key assumptions would not cause the total carrying amount to exceed the recoverable amount - As of June 30, 2025, the carrying amount of goodwill was RMB 471,901 thousand, and intangible assets was RMB 95,708 thousand[242][247] - Goodwill impairment assessment was based on cash flow forecasts, using a pre-tax discount rate of 17.5%, expected annual growth rates of 0.5%-278.2%, expected market penetration rates of 0.48%-20.4%, and expected commercialization success rates of 33.0%-38.0%[244][245] - Intangible asset impairment assessment used a pre-tax discount rate of 18.0%, expected annual growth rates of 1.4%-174.6%, expected market penetration rates of 1.5%-9.0%, and expected commercialization success rate of 38%[248][249] - Impairment test results for goodwill and intangible assets indicated that the estimated recoverable amount of the cash-generating unit exceeded its carrying amount, thus no impairment was recognized[245][250] - Sensitivity tests showed that even with a 1% increase in discount rate or a 1% decrease in revenue compound growth rate, there was sufficient headroom in the recoverable amount of goodwill and intangible assets, not causing the total carrying amount to exceed the recoverable amount[246][251] Trade and Other Receivables As of June 30, 2025, the company's trade and other receivables totaled RMB 20,735 thousand, a decrease from RMB 31,561 thousand as of December 31, 2024; trade receivables (net of credit loss allowance) were RMB 8,727 thousand, with the largest portion aged over 365 days Trade and Other Receivables Details (As of June 30, 2025) | Item | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Trade Receivables (net of credit loss allowance) | 8,727 | 18,345 | | Interest Receivable | 4,771 | 3,949 | | Prepayments | 6,486 | 7,528 | | Other Receivables (net of credit loss allowance) | 751 | 1,739 | | Total | 20,735 | 31,561 | Ageing Analysis of Trade Receivables (As of June 30, 2025) | Ageing | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Within 30 days | 330 | 621 | | 31 to 60 days | – | 223 | | 61 to 90 days | 53 | 186 | | 91 to 120 days | 823 | 32 | | 121 to 365 days | 294 | 212 | | Over 365 days | 7,227 | 17,071 | | Total | 8,727 | 18,345 | Trade and Other Payables As of June 30, 2025, the company's trade and other payables totaled RMB 96,287 thousand, a decrease from RMB 113,929 thousand as of December 31, 2024; trade payables were RMB 66,863 thousand, with the largest portion aged over 365 days Trade and Other Payables Details (As of June 30, 2025) | Item | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Trade Payables | 66,863 | 83,143 | | Accrued R&D Expenses | 14,892 | 11,558 | | Other Payables | 9,557 | 13,538 | | Interest Payable | 142 | 187 | | Other Taxes Payable | 657 | 1,418 | | Accrued Staff Costs and Benefits | 4,176 | 4,085 | | Total | 96,287 | 113,929 | Ageing Analysis of Trade Payables (As of June 30, 2025) | Ageing | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | 0 to 30 days | 13,374 | 9,699 | | 31 to 60 days | 795 | 988 | | 61 to 90 days | 1,022 | 1,106 | | 91 to 120 days | 815 | 1,273 | | 121 to 365 days | 23,933 | 34,267 | | Over 365 days | 26,924 | 35,810 | | Total | 66,863 | 83,143 | Borrowings and Deferred Income As of June 30, 2025, the company incurred new borrowings of RMB 157,980 thousand and repaid borrowings of RMB 197,174 thousand; total deferred income was RMB 54,700 thousand, primarily comprising conditional government grants and asset-related grants - For the six months ended June 30, 2025, the company incurred new borrowings of RMB 157,980 thousand and repaid borrowings of RMB 197,174 thousand[257] - Borrowings bear interest at fixed and floating market rates (ranging from 2.90% to 3.80%) and are repayable in installments over a period of 1 to 16 months[257] Deferred Income (As of June 30, 2025) | Item | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Government Grants (Conditional) | 50,700 | 50,700 | | Asset-Related Grants | 4,000 | 8,000 | | Total | 54,700 | 58,700 | | Less: Current Portion | (4,400) | (8,400) | | Non-current Portion | 50,300 | 50,300 | Share Capital and Treasury Shares As of June 30, 2025, the company's total issued ordinary shares were 437,381,945, with a share capital of RMB 285 thousand; during the period, 166,500 shares were repurchased for a total consideration of RMB 93 thousand and held as treasury shares, bringing the total treasury shares to 27,291,758 at period-end Share Capital Details (As of June 30, 2025) | Item | Number of Shares | Amount (RMB thousand) | | :--- | :--- | :--- | | Issued and Fully Paid as of January 1, 2025 | 436,432,445 | 284 | | Ordinary Shares Issued upon Exercise of Share Options | 49,500 | –* | | Shares Issued and Held in Trust | 900,000 | 1 | | Issued and Fully Paid as of June 30, 2025 | 437,381,945 | 285 | Treasury Shares Details (As of June 30, 2025) | Item | Number of Shares | Amount (RMB thousand) | | :--- | :--- | :--- | | As of January 1, 2025 | 30,429,134 | 2,371 | | Shares Repurchased | 166,500 | 93 | | Vesting of Restricted Share Units | (4,203,876) | (3) | | Shares Issued and Held in Trust | 900,000 | 1 | | As of June 30, 2025 | 27,291,758 | 2,462 | - For the six months ended June 30, 2025, the company repurchased 166,500 shares at an average price of RMB 0.56, totaling RMB 93,000, and held them as treasury shares[261] Share-based Payment Transactions The company operates a Pre-IPO Share Incentive Scheme and a Post-IPO Share Award Scheme (Share Incentive Scheme) to incentivize employees; as of June 30, 2025, a significant number of share options and restricted share units under both schemes remained unexercised or unvested, and share-based payment expenses of RMB 9,339 thousand were recognized during the period Pre-IPO Share Incentive Scheme Movements (As of June 30, 2025) | Category | Unexercised as of January 1, 2025 (thousand shares) | Forfeited during the Period (thousand shares) | Exercised/Vested during the Period (thousand shares) | Unexercised as of June 30, 2025 (thousand shares) | | :--- | :--- | :--- | :--- | :--- | | Directors and Senior Management of the Company | 4,950 | (1,496) | (375) | 3,079 | | Consultants | 705 | – | – | 705 | | Employees | 10,724 | (5) | (161) | 10,558 | | Total | 16,379 | (1,501) | (536) | 14,342 | Post-IPO Share Award Scheme Movements (As of June 30, 2025) | Category | Unexercised as of January 1, 2025 (thousand shares) | Granted during the Period (thousand shares) | Forfeited during the Period (thousand shares) | Exercised/Vested during the Period (thousand shares) | Unexercised as of June 30, 2025 (thousand shares) | | :--- | :--- | :--- | :--- | :--- | :--- | | Directors and Senior Management of the Company | 24,474 | 90 | (4,156) | (567) | 19,841 | | Consultants | – | 2,000 | – | – | 2,000 | | Employees | 8,524 | 676 | (123) | (3,150) | 5,927 | | Total | 32,998 | 2,766 | (4,279) | (3,717) | 27,768 | - During this interim period, the company granted 2,766,000 restricted share units/share options, with fair values ranging from USD 0.0974 to USD 0.1933[269] - For the six months ended June 30, 2025, the company recognized share-based payment expenses of RMB 9,339 thousand[270] Related Party Transactions and Capital Commitments As of June 30, 2025, the company had a related party balance of trade receivables of RMB 4,720 thousand with a joint venture; total remuneration for key management personnel was RMB 7,559 thousand; regarding capital commitments, contracted but unprovided capital expenditure for property, plant, and equipment amounted to RMB 5,002 thousand Related Party Balances (As of June 30, 2025) | Relationship | Nature of Balance | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | :--- | | A Joint Venture | Trade Receivables | 4,720 | 4,720 | Key Management Personnel Remuneration (Six Months Ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Short-term Benefits | 4,868 | 5,250 | | Post-employment Benefits | 537 | 749 | | Share-based Payments | 2,154 | 4,267 | | Discretionary Bonuses | – | 18 | | Total | 7,559 | 10,284 | Capital Commitments (As of June 30, 2025) | Item | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Capital Expenditure Contracted but Not Provided for in the Condensed Consolidated Financial Statements – Property, Plant and Equipment | 5,002 | 6,217 | Definitions Definitions of Terms This section provides definitions for key terms and abbreviations used in the report, covering professional vocabulary related to corporate governance, finance, business operations, and regulation, to ensure clear understanding of the report content - Defined key terms such as "associate," "Articles of Association," "Audit Committee," "CDMO," "CG Code," "China," "CMC," "Company," "Directors," "Dr. Qian," "Eli Lilly," "FDA," "GMP," "Group," "Hong Kong," "HK$," "IFRS," "IND," "Listing," "Listing Date," "Listing Rules," "Main Board," "Model Code," "NMPA," "Option," "Pre-IPO Share Incentive Scheme," "Prospectus," "R&D," "Reporting Period," "RMB," "Restricted Share Unit," "SFO," "Share Incentive Scheme," "Share(s)," "Shareholder(s)," "Stock Exchange," "subsidiary," "substantial shareholder," "Success Link," "US," and "US$"[275][276][277][278][279][281]