智通财经APP讯，迈博药业-B(02181)发布2025年中期业绩，营业收入2.74亿元(人民币，下同)，同比增 加152.7%;股东应占溢利289.8万元，上年同期股东应占亏损9756.9万元，同比扭亏为盈;每股基本盈利0 元。 ...

[Company Information and Forward-Looking Statements](index=1&type=section&id=Company%20Information%20and%20Forward-Looking%20Statements) [Company Profile](index=1&type=section&id=Company%20Profile) Mabpharm Limited focuses on the R&D and industrialization of new drugs and biosimilars for cancer and autoimmune diseases - Mabpharm Limited released its unaudited consolidated financial results for the six months ended June 30, 2025[3](index=3&type=chunk) - The company's main business is the R&D, development, manufacturing, and intellectual property transfer of monoclonal antibody drugs for cancer and autoimmune diseases[92](index=92&type=chunk) [Forward-Looking Statements](index=1&type=section&id=Forward-Looking%20Statements) The report contains forward-looking statements involving risks and uncertainties that may cause actual results to differ materially from expectations - This announcement contains forward-looking statements that involve known and unknown risks and uncertainties[2](index=2&type=chunk) - Actual results, performance, or achievements may differ materially from those expressed in the forward-looking statements[2](index=2&type=chunk) - The company undertakes no obligation to update or revise any forward-looking statements[2](index=2&type=chunk) [Interim Results Summary](index=2&type=section&id=Interim%20Results%20Summary) [Consolidated Financial Performance Overview](index=2&type=section&id=Consolidated%20Financial%20Performance%20Overview) The company achieved a significant turnaround, with revenue growing 152.7% to RMB 274 million and recording a profit of RMB 2.9 million Key Financial Data for H1 2025 (RMB in thousands) | Indicator | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 274,183 | 108,483 | 152.7 | | Cost of sales | (32,938) | (14,127) | 133.2 | | Gross profit | 241,245 | 94,356 | 155.7 | | R&D expenses | (23,809) | (56,293) | (57.7) | | Administrative expenses | (51,366) | (60,651) | (15.3) | | Profit/(loss) before tax | 2,898 | (97,569) | (103.0) | | Total profit/(loss) for the period | 2,898 | (97,569) | (103.0) | | Net assets | 98,863 | 88,934 | 11.2 | | Net current assets | 27,290 | 53,649 | (49.1) | - The company achieved profitability with a **152.7% year-over-year increase in revenue**, primarily driven by new drug launches and sales promotion[5](index=5&type=chunk) [Business Overview and Core Products](index=3&type=section&id=Business%20Overview%20and%20Core%20Products) [Corporate Strategy and Core Competencies](index=3&type=section&id=Corporate%20Strategy%20and%20Core%20Competencies) Mabpharm is a leading biopharmaceutical company in China focusing on innovative and biosimilar drugs for cancer and autoimmune diseases - The company is a leading biopharmaceutical company in China, specializing in the R&D and industrialization of new drugs and biosimilars for cancer and autoimmune diseases[5](index=5&type=chunk) - It is committed to providing high-quality, affordable innovative biopharmaceuticals through an efficient R&D system and low-cost manufacturing capabilities[5](index=5&type=chunk) - The industrialization business has entered a high-growth phase with the launch and promotion of new drugs[5](index=5&type=chunk) [Core Products and Market Performance](index=3&type=section&id=Core%20Products%20and%20Market%20Performance) The company's three core products, CMAB009, CMAB007, and CMAB008, have achieved significant market progress and sales growth - The company's drug pipeline includes 9 monoclonal antibody drugs and 1 potent antibody drug, with 3 approved as core products[5](index=5&type=chunk) - Core products **CMAB009, CMAB007, and CMAB008** have all been approved for marketing and included in the National Reimbursement Drug List, achieving substantial sales volume growth[5](index=5&type=chunk)[9](index=9&type=chunk) - The company is actively expanding new indications and overseas markets for its core products, with CMAB008 approved for sale in several foreign countries[6](index=6&type=chunk)[11](index=11&type=chunk) [CMAB009 Enlituo® (Cetuximab beta for Injection)](index=3&type=section&id=CMAB009%20Enlituo%C2%AE%20(Cetuximab%20beta%20for%20Injection)) CMAB009 is the first domestically developed anti-EGFR monoclonal antibody innovative drug, showing superior safety and rapid sales growth - CMAB009 Enlituo® was approved by the NMPA in June 2024 for the first-line treatment of RAS/BRAF wild-type metastatic colorectal cancer[5](index=5&type=chunk) - As the first self-developed EGFR-targeting antibody new drug launched in China in nearly two decades, it demonstrates significant clinical efficacy and better safety (no black box warning)[5](index=5&type=chunk) - It has been successfully included in the National Reimbursement Drug List, with **sales volume increasing by more than 10 times** compared to the previous six months[5](index=5&type=chunk)[6](index=6&type=chunk) [CMAB007 Omasu® (Omalizumab α for Injection)](index=4&type=section&id=CMAB007%20Omasu%C2%AE%20(Omalizumab%20%CE%B1%20for%20Injection)) CMAB007 is China's first domestically produced therapeutic antibody for allergic asthma, with sales steadily increasing post-launch - CMAB007 Omasu® was approved in May 2023 as China's first domestically produced therapeutic antibody new drug for allergic asthma[7](index=7&type=chunk) - A Phase III clinical trial for chronic spontaneous urticaria has been initiated[7](index=7&type=chunk) - As an exclusive product listed in the National Reimbursement Drug List, its **sales volume increased by 4.8%** compared to the previous six months[9](index=9&type=chunk) [CMAB008 Class-Stop® (Infliximab for Injection)](index=5&type=section&id=CMAB008%20Class-Stop%C2%AE%20(Infliximab%20for%20Injection)) CMAB008 is approved for six indications and is expanding into international markets, with significant sales growth - CMAB008 Class-Stop® was approved in July 2021 for six indications and is automatically included in the medical insurance list[9](index=9&type=chunk) - During the reporting period, **sales volume increased by 31.8%** compared to the previous six months, indicating effective market promotion[10](index=10&type=chunk) - Registration and expansion efforts have been initiated in over thirty countries, with sales approval granted in Peru, Indonesia, Pakistan, and Bangladesh[11](index=11&type=chunk) [R&D Pipeline and Production Capacity](index=6&type=section&id=R&D%20Pipeline%20and%20Production%20Capacity) [Overview of Drug Candidate R&D](index=8&type=section&id=Overview%20of%20Drug%20Candidate%20R&D) The company maintains a rich pipeline of drug candidates across multiple therapeutic areas, advancing them toward regulatory approval - The company's pipeline covers cancer, respiratory diseases, autoimmune diseases, bone-related diseases, and inflammatory diseases[20](index=20&type=chunk)[21](index=21&type=chunk)[22](index=22&type=chunk) - Core products CMAB009, CMAB007, and CMAB008 are on the market, and an NDA has been submitted for CMAB807/CMAB807X[20](index=20&type=chunk)[21](index=21&type=chunk) Development Status of Major Drug Candidates | Area | Target | Candidate Code | Category | Clinical Stage | Est. Next Milestone | Est. Regulatory Approval | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Cancer | EGFR | CMAB009 | New Drug/Core Product | Marketed | Approved June 2024 | - | | Respiratory | IgE | CMAB007 | New Drug/Core Product | Marketed | Approved May 2023 | - | | Autoimmune | TNFα | CMAB008 | Biosimilar/Core Product | Marketed | Approved July 2021 | - | | Bone-related | RANKL | CMAB807/CMAB807X | Biosimilar | Phase III | NDA Submitted Jan 2025 | Q2 2026 | | Cancer | Non-PD1 | CMAB819 | Biosimilar | Phase I | Int'l Registration Trial 2026 | Q3 2029 | | Cancer | EGFR | CMAB017 | Innovative Drug | Phase I | Phase II Q3 2026 | Q2 2030 | | Autoimmune | IL-17A | CMAB015 | Biosimilar | Phase III | NDA Submission Q2 2026 | Q4 2027 | | Inflammatory | IL-12 & IL-23 | CMAB022 | Biosimilar | Pre-clinical | IND Submission Q3 2026 | Q4 2030 | | Asthma/Allergy | TSLP | CMAB023 | Biosimilar | Pre-clinical | IND Submission Q4 2026 | Q2 2030 | | Autoimmune | IL-4Rα | CMAB016 | Biosimilar | Pre-clinical | IND Submission Q3 2026 | Q2 2029 | [Other Major Drug Candidates](index=6&type=section&id=Other%20Major%20Drug%20Candidates) The company's pipeline includes multiple promising candidates in various clinical stages, targeting significant market opportunities - **CMAB807/CMAB807X (Denosumab)** has completed Phase III trials and an NDA has been submitted, with approval for osteoporosis and other indications expected in Q2 2026[13](index=13&type=chunk)[36](index=36&type=chunk) - Innovative drug **CMAB017 (anti-EGFR potent antibody)** has initiated Phase I clinical studies for advanced solid tumors, with approval expected in Q2 2030[13](index=13&type=chunk)[37](index=37&type=chunk) - **CMAB015 (Secukinumab biosimilar)** is nearing completion of Phase III trials, with approval for psoriasis and other conditions expected in Q4 2027[13](index=13&type=chunk)[39](index=39&type=chunk) - **CMAB819 (Nivolumab biosimilar)** has completed Phase I trials, with approval for various cancers expected in Q3 2029[40](index=40&type=chunk) - **CMAB022 (Ustekinumab biosimilar)** is undergoing process scale-up, with approval for inflammatory diseases like psoriasis expected in Q4 2030[40](index=40&type=chunk)[41](index=41&type=chunk) - **CMAB023 (anti-TSLP monoclonal antibody biosimilar)** is in process development, with approval as a broad-spectrum anti-allergic drug expected in Q2 2030[41](index=41&type=chunk) - **CMAB016 (Dupilumab biosimilar)** has completed initial process research, with approval for atopic dermatitis and asthma expected in Q2 2029[41](index=41&type=chunk) [New Candidate R&D and System](index=18&type=section&id=New%20Candidate%20R&D%20and%20R&D%20System) The company leverages its experienced R&D team and core technology patents to develop new antibody drugs and bifunctional proteins - The company has initiated R&D on a series of new antibody drugs, bifunctional antibodies, and bifunctional proteins for autoimmune diseases and tumors[42](index=42&type=chunk) - The company possesses efficient R&D capabilities, advanced preparation technologies, and low-cost drug production capacity[43](index=43&type=chunk) - The R&D team has over 20 years of experience and holds core technology patents in antibody engineering, humanization, and high-expression vector construction[14](index=14&type=chunk)[43](index=43&type=chunk) [Commercialization and Production Facilities](index=18&type=section&id=Commercialization%20and%20Production%20Facilities) The company operates two GMP-certified production bases in Taizhou with a total cell reactor capacity of 40,000L and is expanding its CDMO business - The company has two production bases in Taizhou; the G79 base has four 1,500L antibody bioreactor systems and has passed GMP compliance inspections[44](index=44&type=chunk) - The Xiangtailu production base has added a new 7,500L GMP drug substance production line, bringing the **total cell reactor capacity to 40,000L**[45](index=45&type=chunk) - The company is actively expanding its CDMO business and signed an industrial-scale CDMO contract in 2025[15](index=15&type=chunk)[46](index=46&type=chunk) [Market Strategy and Future Outlook](index=19&type=section&id=Market%20Strategy%20and%20Future%20Outlook) [Market Development and Marketing](index=19&type=section&id=Market%20Development%20and%20Marketing) The company leverages its competitive advantages to capitalize on national healthcare reform opportunities while actively expanding its global market presence - The company will leverage its advantages in technology, quality, and cost to participate in national healthcare reform and seize market opportunities[46](index=46&type=chunk) - Global market expansion is underway, with **CMAB008** registration initiated in over thirty countries and sales approved in Peru, Indonesia, Pakistan, and Bangladesh[46](index=46&type=chunk) - Products are sold to hospitals and pharmacies through a distributor network, with inventory levels actively monitored to improve efficiency[47](index=47&type=chunk) [Quality Management System](index=20&type=section&id=Quality%20Management%20System) An effective quality management system is in place to ensure all products and services meet high industry and GMP standards - The company has established an effective quality management system covering raw materials, equipment, and finished products to ensure service quality[48](index=48&type=chunk) - A corporate-level quality assurance department is responsible for inspecting product quality and coordinating quality control procedures[48](index=48&type=chunk) - Manufacturing and R&D operations are inspected according to China's national laboratory quality control standards and GMP regulations[48](index=48&type=chunk) [Future Development and Strategy](index=20&type=section&id=Future%20Development%20and%20Strategy) The company's strategy focuses on capitalizing on healthcare reform, advancing its pipeline, investing in technology, and expanding global partnerships - The company will seize opportunities from China's healthcare reform, focusing on gastroenterology, respirology, rheumatology, and oncology markets[50](index=50&type=chunk) - In the short term, the focus will be on the market development of **CMAB008, CMAB007, and CMAB009**, and completing the commercialization of CMAB807/CMAB807X and CMAB015[52](index=52&type=chunk) - The company plans to continue investing in advanced technology and product development, and to attract and retain high-caliber talent[53](index=53&type=chunk)[54](index=54&type=chunk) - The company plans to expand its overseas market presence through partnerships with renowned domestic and international pharmaceutical companies[55](index=55&type=chunk) [Financial Review](index=23&type=section&id=Financial%20Review) [Operating Performance Analysis](index=23&type=section&id=Operating%20Performance%20Analysis) The company's operating performance improved significantly, achieving a turnaround to profitability driven by strong revenue growth and controlled expenses - **Revenue increased by 152.7%** to RMB 274.2 million, driven by solid growth in drug sales and exclusive promotion rights income in mainland China[58](index=58&type=chunk) - **Gross profit grew by 155.7%** to RMB 241.2 million, with the gross profit margin maintained at 88%[60](index=60&type=chunk) - **Profit for the period was RMB 2.9 million**, a significant turnaround from a loss of RMB 97.6 million in the same period last year[72](index=72&type=chunk) [Revenue](index=24&type=section&id=Revenue) Revenue for the six months ended June 30, 2025, reached RMB 274.2 million, a year-over-year increase of 152.7% Revenue Breakdown (RMB in thousands) | Revenue Source | 2025 | 2024 | | :--- | :--- | :--- | | Sales of pharmaceutical products | 249,002 | 98,532 | | Exclusive promotion right income in mainland China | 21,804 | 9,951 | | Sales of materials | 3,186 | – | | Contract service income | 191 | – | | **Total** | **274,183** | **108,483** | - Revenue increased by 152.7% year-over-year, primarily due to growth in pharmaceutical sales and exclusive promotion right income[58](index=58&type=chunk) [Cost of Sales](index=24&type=section&id=Cost%20of%20Sales) The cost of sales increased by 133.2% to RMB 32.9 million, mainly due to a higher volume of pharmaceutical products sold - Cost of sales increased by 133.2% from RMB 14.1 million to RMB 32.9 million[59](index=59&type=chunk) - The increase was primarily due to the higher volume of pharmaceutical products sold during the reporting period[59](index=59&type=chunk) [Gross Profit and Gross Profit Margin](index=24&type=section&id=Gross%20Profit%20and%20Gross%20Profit%20Margin) Gross profit grew by 155.7% to RMB 241.2 million, while the gross profit margin remained stable at 88% - Gross profit increased by 155.7% from RMB 94.4 million to RMB 241.2 million[60](index=60&type=chunk) - The gross profit margin remained stable at 88%, as revenue and cost of sales increased proportionally[60](index=60&type=chunk) [Other Income](index=24&type=section&id=Other%20Income) Other income surged by 357.3% to RMB 6.0 million, mainly from increased government grants and VAT super-credit deductions Other Income Breakdown (RMB in thousands) | Income Source | 2025 | 2024 | | :--- | :--- | :--- | | Bank interest income | 245 | 215 | | Government grants and subsidies related to income | 4,058 | 1,095 | | VAT super-credit deduction | 1,710 | – | | Others | – | 5 | | **Total** | **6,013** | **1,315** | - Other income increased by 357.3%, primarily due to higher government grants and VAT super-credit deductions[61](index=61&type=chunk) [Other Gains and Losses](index=25&type=section&id=Other%20Gains%20and%20Losses) The loss from other gains and losses increased by 5.6% to RMB 0.6 million, driven by impairment losses on receivables Other Gains and Losses Breakdown (RMB in thousands) | Item | 2025 | 2024 | | :--- | :--- | :--- | | Net foreign exchange gains/(losses) | 55 | (454) | | Fair value gains on financial assets at FVTPL | 7 | 115 | | Impairment losses on prepayments and other receivables | (613) | (58) | | Others | – | (125) | | **Total** | **(551)** | **(522)** | - The loss from other gains and losses increased by 5.6% to RMB 0.6 million, as foreign exchange gains were offset by impairment losses on receivables[63](index=63&type=chunk) [R&D Expenses](index=25&type=section&id=R&D%20Expenses) R&D expenses decreased significantly by 57.7% to RMB 23.8 million, mainly due to the capitalization of three R&D products R&D Expenses Breakdown (RMB in thousands) | Expense Item | 2025 | 2024 | | :--- | :--- | :--- | | Contract costs | 2,568 | 20,887 | | Raw materials and consumables | 5,049 | 8,464 | | Employee costs | 11,273 | 17,385 | | Depreciation | 2,341 | 6,584 | | Others | 2,578 | 2,973 | | **Total** | **23,809** | **56,293** | - **R&D expenses decreased by 57.7%** to RMB 23.8 million, primarily because three R&D products were capitalized[65](index=65&type=chunk) [Administrative Expenses](index=26&type=section&id=Administrative%20Expenses) Administrative expenses decreased by 15.3% to RMB 51.4 million, driven by lower employee costs and reduced depreciation Administrative Expenses Breakdown (RMB in thousands) | Expense Item | 2025 | 2024 | | :--- | :--- | :--- | | Employee costs | 21,448 | 27,417 | | Depreciation | 17,199 | 20,371 | | Others | 12,719 | 12,863 | | **Total** | **51,366** | **60,651** | - Administrative expenses decreased by 15.3% to RMB 51.4 million, mainly due to lower employee costs and depreciation[67](index=67&type=chunk) [Finance Costs](index=27&type=section&id=Finance%20Costs) Finance costs remained stable at RMB 5.4 million, consisting mainly of interest on bank and other borrowings Finance Costs Breakdown (RMB in thousands) | Cost Item | 2025 | 2024 | | :--- | :--- | :--- | | Interest on loans from a related party | 205 | 421 | | Interest on bank and other borrowings | 4,082 | 3,651 | | Interest on lease liabilities | 1,138 | 1,346 | | **Total** | **5,425** | **5,418** | - Finance costs increased by 0.1% to RMB 5.4 million, remaining stable compared to the prior period[70](index=70&type=chunk) [Profit/Loss for the Period](index=27&type=section&id=Profit/Loss%20for%20the%20Period) The company achieved a turnaround, recording a profit attributable to owners of RMB 2.9 million compared to a loss last year - Profit attributable to owners of the Company was **RMB 2.9 million**, a significant improvement from the loss of RMB 97.6 million in the prior period[72](index=72&type=chunk) - The turnaround was primarily attributable to increased gross profit and decreased R&D expenses[72](index=72&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) Trade receivables and inventories increased significantly by 53.8% and 31.3% respectively, reflecting higher sales and future demand expectations Analysis of Liquidity and Capital Resources (RMB in thousands) | Item | June 30, 2025 | Dec 31, 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Trade receivables | 145,335 | 94,526 | 53.8 | | Prepayments and other receivables | 24,681 | 31,554 | (21.8) | | Inventories | 145,782 | 111,009 | 31.3 | | Cash and bank balances | 94,162 | 89,344 | 5.4 | | Restricted bank deposits | – | 39,341 | (100.0) | | **Total** | **410,298** | **365,774** | **12.2** | - **Trade receivables increased by 53.8%** to RMB 145.3 million, mainly due to a substantial increase in drug sales volume[73](index=73&type=chunk) - **Inventories increased by 31.3%** to RMB 145.8 million, primarily in anticipation of higher drug demand in the second half of the year[73](index=73&type=chunk) [Indebtedness Structure](index=28&type=section&id=Indebtedness%20Structure) As of June 30, 2025, total debt comprised lease liabilities and interest-bearing borrowings, with related party loans fully repaid Breakdown of Indebtedness (RMB in thousands) | Debt Type | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Lease liabilities | 48,561 | 47,501 | | Interest-bearing bank and other borrowings | 256,449 | 245,591 | | Loans from a related party | – | 18,500 | - As of June 30, 2025, the company had **fully repaid its loans from a related party**[75](index=75&type=chunk) - The existing debt does not contain any material covenants or covenants that could limit the company's ability to incur further debt[75](index=75&type=chunk) [Contingent Liabilities, Pledge of Assets, and Guarantees](index=29&type=section&id=Contingent%20Liabilities,%20Pledge%20of%20Assets,%20and%20Guarantees) The company has pledged land, buildings, and equipment with a total carrying value of RMB 384.3 million to secure loans - The company pledged land and buildings with carrying values of approximately RMB 33.2 million and RMB 156.8 million, respectively, to secure bank loans of RMB 80.0 million[77](index=77&type=chunk) - Equipment with a carrying value of RMB 194.3 million was pledged to secure an entrusted loan of RMB 100.1 million[77](index=77&type=chunk) - Apart from those disclosed, the company had no other material contingent liabilities, mortgages, or similar indebtedness[78](index=78&type=chunk) [Capital Structure and Foreign Exchange Risk](index=29&type=section&id=Capital%20Structure%20and%20Foreign%20Exchange%20Risk) The company's capital structure improved slightly with a higher equity ratio, while it faces foreign exchange risks from HKD and USD - As of June 30, 2025, the company's capital structure consisted of **90.7% debt and 9.3% equity**, showing a slight increase in the equity portion[79](index=79&type=chunk) - The company is exposed to foreign exchange risks arising from HKD and USD, which are managed by closely monitoring the market[80](index=80&type=chunk) - During the reporting period, the company did not enter into any currency hedging transactions[80](index=80&type=chunk) [Gearing Ratio and Liquidity Ratios](index=30&type=section&id=Gearing%20Ratio%20and%20Liquidity%20Ratios) The gearing ratio slightly decreased to 90.7%, while liquidity and quick ratios declined due to increased current liabilities - As of June 30, 2025, the **gearing ratio was 90.7%**, down from 91.2% at the end of 2024[81](index=81&type=chunk) Key Financial Ratios | Ratio | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Current ratio | 1.1 | 1.2 | | Quick ratio | 0.7 | 0.8 | - The current and quick ratios decreased, mainly due to an increase in current liabilities from accrued marketing service fees[84](index=84&type=chunk) [Condensed Consolidated Interim Financial Statements](index=31&type=section&id=Condensed%20Consolidated%20Interim%20Financial%20Statements) [Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=31&type=section&id=Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) The company reported a profit of RMB 2,898 thousand for the period, a significant turnaround from the prior year's loss Summary of Consolidated Statement of Profit or Loss and Other Comprehensive Income (RMB in thousands) | Item | 2025 | 2024 | | :--- | :--- | :--- | | Revenue | 274,183 | 108,483 | | Gross profit | 241,245 | 94,356 | | R&D expenses | (23,809) | (56,293) | | Administrative expenses | (51,366) | (60,651) | | Profit/(loss) before tax | 2,898 | (97,569) | | Profit/(loss) and total comprehensive income/(loss) for the period | 2,898 | (97,569) | | Earnings/(loss) per share attributable to ordinary equity holders of the Company - Basic | RMB0.00 | RMB(0.02) | | Earnings/(loss) per share attributable to ordinary equity holders of the Company - Diluted | RMB0.00 | RMB(0.02) | [Consolidated Statement of Financial Position](index=32&type=section&id=Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2025, total assets stood at RMB 1,067,846 thousand, with net assets increasing to RMB 98,863 thousand Summary of Consolidated Statement of Financial Position (RMB in thousands) | Item | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Total non-current assets | 657,548 | 650,444 | | Total current assets | 410,298 | 365,774 | | Total current liabilities | 383,008 | 312,125 | | Total non-current liabilities | 585,975 | 615,159 | | Net assets | 98,863 | 88,934 | | Total equity | 98,863 | 88,934 | [Consolidated Statement of Changes in Equity](index=33&type=section&id=Consolidated%20Statement%20of%20Changes%20in%20Equity) Total equity increased to RMB 98,863 thousand, primarily driven by profit for the period and share-based compensation Summary of Consolidated Statement of Changes in Equity (RMB in thousands) | Item | Share Capital | Share Premium | Other Reserves | Share Option Reserve | Accumulated Losses | Total Equity | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | At Jan 1, 2025 (Audited) | 2,804 | 1,400,504 | (32,763) | 79,010 | (1,360,621) | 88,934 | | Profit and total comprehensive income for the period | – | – | – | – | 2,898 | 2,898 | | Recognition of equity-settled share-based compensation | – | – | – | 7,031 | – | 7,031 | | At June 30, 2025 (Unaudited) | 2,804 | 1,400,504 | (32,763) | 86,041 | (1,357,723) | 98,863 | [Consolidated Statement of Cash Flows](index=34&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) The company generated a net cash inflow from operating activities of RMB 43,027 thousand, improving its cash position Summary of Consolidated Statement of Cash Flows (RMB in thousands) | Item | 2025 | 2024 | | :--- | :--- | :--- | | Net cash flows from/(used in) operating activities | 43,027 | (64,177) | | Net cash flows used in investing activities | (24,766) | (12,298) | | Net cash flows used in financing activities | (13,459) | (22,812) | | Net increase/(decrease) in cash and cash equivalents | 4,802 | (99,287) | | Cash and cash equivalents at end of period | 94,162 | 74,066 | [Notes to the Condensed Consolidated Interim Financial Information](index=36&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Information) [General Information](index=36&type=section&id=General%20Information) Mabpharm Limited was incorporated in the Cayman Islands and is listed on the Hong Kong Stock Exchange - The Company was incorporated in the Cayman Islands on June 1, 2018, and listed on the Hong Kong Stock Exchange on May 31, 2019[92](index=92&type=chunk) - The Group is principally engaged in the R&D, manufacturing, and intellectual property transfer of monoclonal antibody drugs for cancer and autoimmune diseases[92](index=92&type=chunk) [Basis of Preparation and Changes in Accounting Policies](index=36&type=section&id=Basis%20of%20Preparation%20and%20Changes%20in%20Accounting%20Policies) The interim financial information is prepared in accordance with IAS 34, with accounting policies consistent with the 2024 annual report - The condensed consolidated interim financial information is prepared in accordance with International Accounting Standard 34 Interim Financial Reporting[94](index=94&type=chunk) - The accounting policies adopted are consistent with those of the 2024 annual financial statements, with the first-time adoption of amendments to IAS 21[95](index=95&type=chunk)[96](index=96&type=chunk) - The amendments had no impact on the interim financial information as the Group's transactional and functional currencies are exchangeable[96](index=96&type=chunk) [Operating Segment Information](index=37&type=section&id=Operating%20Segment%20Information) The Group operates as a single reportable segment, with all revenue generated from customers in China - The Group has only one reportable segment as the chief operating decision-maker reviews the consolidated results as a whole for resource allocation[97](index=97&type=chunk) - All revenue during the period was derived from customers in China, and the majority of non-current assets are located in China[98](index=98&type=chunk) - During the reporting period, no single customer accounted for 10% or more of the Group's total revenue[99](index=99&type=chunk) [Revenue Analysis](index=37&type=section&id=Revenue%20Analysis) Total revenue from contracts with customers amounted to RMB 274,183 thousand, primarily from pharmaceutical sales in mainland China Disaggregation of Revenue from Contracts with Customers (RMB in thousands) | Revenue Source | 2025 | 2024 | | :--- | :--- | :--- | | Sales of pharmaceutical products | 249,002 | 98,532 | | Exclusive promotion right income in mainland China | 21,804 | 9,951 | | Sales of materials | 3,186 | – | | Contract service income | 191 | – | | **Total** | **274,183** | **108,483** | | **Geographical markets** | | | | Mainland China | 274,183 | 108,483 | | **Timing of revenue recognition** | | | | Over time | 21,804 | 9,951 | | At a point in time | 252,379 | 98,532 | [Other Income Analysis](index=38&type=section&id=Other%20Income%20Analysis) Other income totaled RMB 6,013 thousand, mainly comprising government grants and VAT super-credit deductions Other Income Breakdown (RMB in thousands) | Income Source | 2025 | 2024 | | :--- | :--- | :--- | | Bank interest income | 245 | 215 | | Government grants and subsidies related to income | 4,058 | 1,095 | | VAT super-credit deduction benefits | 1,710 | – | | Others | – | 5 | | **Total** | **6,013** | **1,315** | [Other Gains and Losses Analysis](index=39&type=section&id=Other%20Gains%20and%20Losses%20Analysis) Other gains and losses resulted in a net loss of RMB 551 thousand, primarily due to impairment losses on receivables Other Gains and Losses Breakdown (RMB in thousands) | Item | 2025 | 2024 | | :--- | :--- | :--- | | Net foreign exchange gains/(losses) | 55 | (454) | | Fair value gains on financial assets at FVTPL | 7 | 115 | | Impairment losses on prepayments and other receivables | (613) | (58) | | Others | – | (125) | | **Total** | **(551)** | **(522)** | [Finance Costs Analysis](index=39&type=section&id=Finance%20Costs%20Analysis) Finance costs totaled RMB 5,425 thousand, mainly consisting of interest on bank borrowings and lease liabilities Finance Costs Breakdown (RMB in thousands) | Cost Item | 2025 | 2024 | | :--- | :--- | :--- | | Interest on loans from a related party | 205 | 421 | | Interest on bank and other borrowings | 4,082 | 3,651 | | Interest on lease liabilities | 1,138 | 1,346 | | **Total** | **5,425** | **5,418** | [Profit/Loss Before Tax](index=40&type=section&id=Profit/Loss%20Before%20Tax) The company achieved a profit before tax of RMB 2,898 thousand, a significant turnaround from the prior year's loss - Profit before tax was **RMB 2,898 thousand**, compared to a loss of RMB 97,569 thousand in the prior period, marking a successful turnaround[86](index=86&type=chunk) - Key adjustments include depreciation of property, plant and equipment of RMB 27,276 thousand, employee costs of RMB 34,368 thousand, and share-based payment expenses of RMB 7,031 thousand[105](index=105&type=chunk) [Income Tax](index=40&type=section&id=Income%20Tax) The company is exempt from income tax in the Cayman Islands, and no provision for income tax was made for its subsidiaries - The Company is incorporated in the Cayman Islands and is exempted from income tax[106](index=106&type=chunk) - No provision for income tax has been made as subsidiaries in Hong Kong and China had no assessable profits[106](index=106&type=chunk) [Dividends and Earnings/Loss Per Share](index=41&type=section&id=Dividends%20and%20Earnings/Loss%20Per%20Share) No interim dividend was declared, and basic and diluted earnings per share were both RMB 0.00, improving from a loss per share - No dividend was paid or proposed for ordinary shareholders of the Company for the six months ended June 30, 2025[107](index=107&type=chunk) Earnings/Loss Per Share (RMB) | Item | 2025 | 2024 | | :--- | :--- | :--- | | Basic earnings/(loss) per share | 0.00 | (0.02) | | Diluted earnings/(loss) per share | 0.00 | (0.02) | - The weighted average number of ordinary shares for calculating basic and diluted earnings/loss per share was 4,124,080 thousand shares[110](index=110&type=chunk) [Property, Plant and Equipment](index=41&type=section&id=Property,%20Plant%20and%20Equipment) The Group acquired assets at a cost of RMB 8,145 thousand, primarily related to construction in progress - During the six months ended June 30, 2025, the Group acquired assets at a cost of RMB 8,145 thousand[111](index=111&type=chunk) - The asset acquisitions mainly comprised construction in progress of RMB 8,040 thousand[111](index=111&type=chunk) [Other Non-current Assets](index=41&type=section&id=Other%20Non-current%20Assets) Other non-current assets totaled RMB 3,384 thousand, mainly prepayments for the new production facility in Taizhou High-tech Zone Other Non-current Assets Breakdown (RMB in thousands) | Item | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Prepayments for acquisition of property, plant and equipment | 3,293 | 2,407 | | Deposits | 91 | 447 | | **Total** | **3,384** | **2,854** | - Prepayments for the acquisition of property, plant and equipment are mainly related to the construction of the new production facility in Taizhou High-tech Zone[112](index=112&type=chunk) [Trade Receivables](index=42&type=section&id=Trade%20Receivables) Trade receivables totaled RMB 145,335 thousand, with the increase reflecting a significant growth in pharmaceutical sales volume Ageing Analysis of Trade Receivables (RMB in thousands) | Ageing | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Within 3 months | 123,802 | 75,807 | | 4 to 6 months | 15,572 | 11,482 | | 7 to 9 months | 5,820 | 6,283 | | 10 to 12 months | 141 | 954 | | **Total** | **145,335** | **94,526** | - Trade receivables increased by 53.8% to RMB 145,335 thousand, primarily due to a substantial increase in drug sales volume[73](index=73&type=chunk) [Prepayments and Other Receivables](index=42&type=section&id=Prepayments%20and%20Other%20Receivables) Prepayments and other receivables amounted to RMB 24,681 thousand, with prepayments for R&D services being the largest component Prepayments and Other Receivables Breakdown (RMB in thousands) | Item | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Other receivables | 3,139 | 1,560 | | Prepayments for R&D services | 18,476 | 18,628 | | Other deposits and prepayments | 3,061 | 3,722 | | VAT recoverable | 5 | 7,644 | | **Total** | **24,681** | **31,554** | [Trade and Other Payables](index=43&type=section&id=Trade%20and%20Other%20Payables) Trade and other payables totaled RMB 216,751 thousand, with accrued marketing service fees being the largest component Trade and Other Payables Breakdown (RMB in thousands) | Item | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Trade payables | 29,235 | 11,709 | | Accrued R&D service expenses | 24,132 | 22,807 | | Other payables for purchase of property, plant and equipment | 6,695 | 33,671 | | Payroll and bonus payables | 10,488 | 13,289 | | Other tax payables | 8,463 | 634 | | Accrued listing expenses and issuance costs | 11,295 | 11,189 | | Accrued marketing service fees | 119,770 | 71,332 | | Other payables | 6,673 | 4,736 | | **Total** | **216,751** | **169,367** | - The credit period on trade payables is generally 60 days from the date of receipt of goods and/or services[115](index=115&type=chunk) [Interest-bearing Bank and Other Borrowings](index=44&type=section&id=Interest-bearing%20Bank%20and%20Other%20Borrowings) Total interest-bearing borrowings amounted to RMB 256,449 thousand, comprising both current and non-current loans Details of Interest-bearing Bank and Other Borrowings (RMB in thousands) | Borrowing Type | Effective Interest Rate (%) | Maturity | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Current** | | | | | | Bank loans (secured) | LPR+50 bps | 2025 | 89,987 | 80,054 | | **Non-current** | | | | | | Other loans (unsecured) | 4.0% | 2032 | 66,366 | 65,537 | | Bank loans (secured) | LPR | 2026 | 100,096 | 100,000 | | **Total** | | | **256,449** | **245,591** | - The difference between the carrying amounts and fair values of the non-current portion of interest-bearing bank and other borrowings is negligible[117](index=117&type=chunk) [Share Capital](index=45&type=section&id=Share%20Capital) As of June 30, 2025, the company's issued and fully paid share capital was RMB 2,804 thousand - As of June 30, 2025, the company's issued and fully paid share capital was RMB 2,804 thousand[118](index=118&type=chunk) - The share capital consisted of 4,124,080,000 ordinary shares with a par value of US$0.0001 each[118](index=118&type=chunk) [Capital Commitments](index=45&type=section&id=Capital%20Commitments) The Group had capital commitments of RMB 3,715 thousand for equipment purchases and building construction Capital Commitments (RMB in thousands) | Item | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Contracted, but not provided for | 3,715 | 4,223 | - Capital commitments are mainly related to the new production facility in Taizhou High-tech Zone[119](index=119&type=chunk) [Related Party Transactions](index=46&type=section&id=Related%20Party%20Transactions) The Group conducted several transactions with its related party, Biomabs, including the repayment of loans and interest Related Party Transactions during the Period (RMB in thousands) | Transaction Type | 2025 | 2024 | | :--- | :--- | :--- | | Repayment of loans from a related party - principal | (18,500) | – | | Interest on loans from a related party | 205 | 421 | | Repayment of interest on loans from a related party | 1,801 | – | Amounts due to a Related Party (RMB in thousands) | Item | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Trade payables (Biomabs) | 47,280 | 47,280 | | Interest payables (Biomabs) | – | 1,596 | | Loans payable (Biomabs) | – | 18,500 | | **Total** | **47,280** | **67,376** | - The trade payables to Biomabs of RMB 47,280 thousand, related to the acquisition of intellectual property for CMAB807, have had their due date extended to December 31, 2027[123](index=123&type=chunk) Compensation of Key Management Personnel (RMB in thousands) | Compensation Item | 2025 | 2024 | | :--- | :--- | :--- | | Salaries and other benefits | 2,396 | 1,819 | | Pension scheme contributions | 175 | 140 | | Directors' fees | 220 | 165 | | Share-based compensation | 6,231 | 7,567 | | **Total** | **9,022** | **9,691** | [Other Corporate Information](index=49&type=section&id=Other%20Corporate%20Information) [Interim Dividend](index=49&type=section&id=Interim%20Dividend) The Board of Directors has recommended that no interim dividend be paid for the six months ended June 30, 2025 - The Board of Directors recommends that no interim dividend be paid for the six months ended June 30, 2025[126](index=126&type=chunk) [Use of Net Proceeds from Listing](index=49&type=section&id=Use%20of%20Net%20Proceeds%20from%20Listing) The net proceeds of approximately HK$1,144.5 million from the global offering have been fully utilized as intended - The net proceeds from the global offering of approximately **HK$1,144.5 million have been fully utilized**[127](index=127&type=chunk) - The use of net proceeds was in accordance with the intentions set out in the prospectus[127](index=127&type=chunk) [Material Investments, Acquisitions and Disposals](index=49&type=section&id=Material%20Investments,%20Acquisitions%20and%20Disposals) The Group held no material investments and made no significant acquisitions or disposals during the reporting period - As of June 30, 2025, the Group did not hold any material investments[128](index=128&type=chunk) - There were no future plans for material investments or capital assets during the reporting period[128](index=128&type=chunk) - There were no material acquisitions or disposals of subsidiaries, associates, or joint ventures during the reporting period[128](index=128&type=chunk) [Employees and Remuneration Policy](index=49&type=section&id=Employees%20and%20Remuneration%20Policy) As of June 30, 2025, the company had 383 employees, with a focus on attracting and retaining high-caliber R&D talent Number of Employees by Function | Function | Number of Employees | | :--- | :--- | | Business Unit | 67 | | R&D Staff | 253 | | Administration | 20 | | Management | 43 | | **Total** | **383** | - The company is committed to attracting, recruiting, and retaining qualified employees by offering opportunities to work on cutting-edge biologics projects[130](index=130&type=chunk) - Employee remuneration includes salaries and bonuses, with contributions made to social insurance funds; a labor union has been established in Taizhou[131](index=131&type=chunk) [Corporate Governance and Securities Transactions](index=50&type=section&id=Corporate%20Governance%20and%20Securities%20Transactions) The Group is committed to high standards of corporate governance and has complied with all applicable code provisions - The Group is committed to maintaining high standards of corporate governance and has adopted the Corporate Governance Code[132](index=132&type=chunk) - The Board believes the company has complied with all applicable code provisions of the Corporate Governance Code during the reporting period[132](index=132&type=chunk) - The company has adopted the Model Code for securities transactions by directors, and all directors have confirmed their compliance[133](index=133&type=chunk) [Material Litigation](index=51&type=section&id=Material%20Litigation) The company was not involved in any material litigation or arbitration during the reporting period - During the reporting period, the Company was not involved in any material litigation or arbitration[135](index=135&type=chunk) - The directors are not aware of any pending or threatened material litigation or claims against the Group[135](index=135&type=chunk) [Audit Committee and Review of Financial Report](index=51&type=section&id=Audit%20Committee%20and%20Review%20of%20Financial%20Report) The Audit Committee has reviewed the interim financial statements and confirmed the adequacy of the internal control system - The Audit Committee has reviewed the Group's interim consolidated financial statements for the six months ended June 30, 2025[136](index=136&type=chunk) - The Audit Committee discussed accounting principles, policies, and internal control matters with senior management and the external auditor, Ernst & Young[136](index=136&type=chunk) - The Audit Committee is satisfied that the internal control system is sufficient to identify, manage, and mitigate various operational risks[136](index=136&type=chunk) [Important Events After the Reporting Date](index=52&type=section&id=Important%20Events%20After%20the%20Reporting%20Date) There were no significant events requiring disclosure between June 30, 2025, and the date of this announcement - From June 30, 2025, up to the date of this announcement, there were no important events requiring disclosure by the Group[137](index=137&type=chunk) [Publication of Interim Report and Acknowledgement](index=52&type=section&id=Publication%20of%20Interim%20Report%20and%20Acknowledgement) The interim report will be published on the websites of the Stock Exchange and the company in due course - This announcement is published on the websites of the Stock Exchange and the Company[138](index=138&type=chunk) - The interim report for the six months ended June 30, 2025, will be published in due course[138](index=138&type=chunk) - The Board extends its sincere thanks and appreciation to all shareholders, business partners, and employees[139](index=139&type=chunk) [Definitions](index=52&type=section&id=Definitions) This section provides definitions for key terms and abbreviations used throughout the report to ensure clear understanding - This section provides definitions for key terms and abbreviations used in the report[140](index=140&type=chunk) - Definitions include company names, core products (CMAB007, CMAB009, and CMAB008), regulatory bodies (NMPA), and financial terms (NDA, GMP)[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk)

Core Insights - Colorectal cancer (CRC) is the second most common malignant tumor in China, with 517,100 new cases in 2022, accounting for 10.7% of all cancer cases, and 240,000 deaths, representing 9.3% of all cancer deaths [1][12] - The global colorectal cancer drug market is projected to grow from $16.9 billion in 2019 to $25.4 billion by 2024, indicating significant market potential [1][13] - The Chinese colorectal cancer drug market is expected to reach 24.21 billion yuan by 2024, with an 18.5% year-on-year growth [1][16] - The market is characterized by a competitive landscape with multiple companies across different tiers, including leading firms like Junshi Biosciences and others [1][18] Industry Overview - Colorectal cancer drugs include traditional chemotherapy, targeted therapies, and immunotherapies, which are crucial for extending patient survival [2] - The burden of colorectal cancer in China is significant, with over 80% of patients diagnosed at advanced stages, leading to high treatment demands [1][16] - The market is expected to continue growing, with projections of 37.3 billion yuan by 2027 and nearly 60 billion yuan by 2031 [1][20] Competitive Landscape - The colorectal cancer drug industry features a tiered structure: - First tier: Junshi Biosciences - Second tier: Maibao Pharmaceutical, Hutchison China MediTech - Third tier: JAKS Pharmaceuticals, Jinfang Pharmaceutical [1][18] - Over 10 innovative therapies have been approved globally for colorectal cancer treatment, with more in clinical trials [1][18] Future Trends - The market is expected to see a shift towards precision medicine, with targeted and immunotherapies becoming mainstream [1][22] - Domestic innovative pharmaceutical companies are rapidly emerging, enhancing their product lines through independent research and global collaborations [1][23] - Upgraded patient needs will drive innovations in service models, focusing on unmet clinical demands and improving treatment experiences [1][25]

Core Viewpoint - The company, Maibo Pharmaceutical-B (02181.HK), has announced a board meeting scheduled for August 28, 2025, to consider and approve its interim results for the six months ending June 30, 2025, along with addressing other matters [1]. Group 1 - The board meeting will take place on August 28, 2025 [1] - The meeting will focus on the approval of the interim results for the six months ending June 30, 2025 [1] - Other matters will also be addressed during the board meeting [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全 部 或 任 何 部 分 內 容 產 生 或 因 倚 賴 該 等 內 容 而 引 致 的 任 何 損 失 承 擔 任 何 責 任。 邁博藥業有限公司（「本公司」）董 事 會（「董事會」）謹 此 宣 佈，本 公 司 將 於 二 零 二 五 年 八 月 二 十 八 日（星 期 四）舉 行 董 事 會 會 議，藉 以（其 中 包 括）考 慮 及 批 准 本 公 司 及 其 附 屬 公 司 截 至 二 零 二 五 年 六 月 三 十 日 止 六 個 月 之 中 期 業 績 及 其 發 佈，以 及 處 理 任 何 其 他 事 項。 承董事會命 邁博藥業有限公司 主 席 焦樹閣 香 港，二 零 二 五 年 八 月 十 四 日 於本公告日期，本公司董事會包括執行董事王皓博士、李雲峰先生、陶靜先生、 侯 盛 博 士 及 錢 衛 珠 博 士；非 執 行 董 事 焦 樹 閣 先 生 及 岑 佳 麟 先 生；及 獨 立 非 執 行 董 事 ...

Company Overview - MaiBo Pharmaceutical Co., Ltd. (stock code 02181.HK) is a publicly listed company on the Hong Kong Stock Exchange, focusing on the research and production of new drugs and biosimilars for cancer and autoimmune diseases [2] - The company aims to deliver high-quality and affordable innovative biopharmaceuticals through an efficient R&D system and low-cost production capabilities [2] - MaiBo has developed a robust R&D and industrialization platform, mastering core technologies for large-scale antibody drug preparation, and has three antibody drugs successfully approved for market sale [2] Financial Performance - As of December 31, 2024, MaiBo achieved total revenue of 258 million yuan, representing a year-on-year growth of 196.27% [1] - The company reported a net profit attributable to shareholders of -128 million yuan, with a year-on-year increase of 38.89% [1] - The gross profit margin stood at 84.96%, while the debt-to-asset ratio was 91.25% [1] Market Performance - As of August 11, the stock price of MaiBo Pharmaceutical-B was 0.71 HKD per share, reflecting a 22.41% increase with a trading volume of 2.261 million shares and a turnover of 1.4792 million HKD [1] - Over the past month, the stock has seen a cumulative increase of 16%, and since the beginning of the year, it has surged by 107.14%, outperforming the Hang Seng Index by 23.92% [1] Industry Valuation - The average price-to-earnings (P/E) ratio for the pharmaceutical and biotechnology industry is -1.18 times, with a median of 4.48 times [1] - MaiBo's P/E ratio is -17.31 times, ranking 116th in the industry [1] - Comparatively, other companies in the sector have P/E ratios such as Jingxin Pharmaceutical (1.29 times), Kingsray Biotechnology (1.61 times), Dongrui Pharmaceutical (3.35 times), Hutchison China MediTech (5.61 times), and Jilin Changlong Pharmaceutical (5.89 times) [1]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年7月31日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 迈博药业有限公司 | | | | | | 呈交日期: | 2025年8月4日 | | | | | | I. 法定/註冊股本變動 | | | | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 (註1) | 是 | | 證券代號 (如上市) | 02181 | 說明 | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 法定/註冊股份數目 | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 50,000,000,000 | USD | 0.0001 USD | | 5,000,000 | | 增加 / 減少 (-) | | | | | USD | | | | 本月 ...

Financial Performance - The company reported a revenue of RMB 258,228,000 for 2024, representing a 196.3% increase compared to RMB 87,161,000 in 2023[9]. - Gross profit for 2024 was RMB 219,394,000, up 191.6% from RMB 75,238,000 in the previous year[9]. - The company achieved a significant reduction in pre-tax loss, which decreased by 38.9% to RMB 127,947,000 from RMB 209,356,000 in 2023[9]. - The company's net asset value fell by 56.6% to RMB 88,934,000 from RMB 205,057,000 in the previous year[9]. - The company's operating revenue increased by 196.3% from RMB 87.2 million in 2023 to RMB 258.2 million in 2024, primarily due to the new launch of CMAB009 and solid sales growth of CMAB007 and CMAB008[69]. - The operating costs rose by 225.7% from RMB 11.9 million in 2023 to RMB 38.8 million in 2024, mainly due to the increase in sales volume of pharmaceuticals[71]. - Gross profit increased by 191.6% from RMB 75.2 million in 2023 to RMB 219.4 million in 2024, with a stable gross margin of 85.0%[72]. - Other income rose by 123.7% from RMB 3.6 million in 2023 to RMB 8.0 million in 2024, mainly due to an increase in government subsidies and grants[74]. Product Development and Pipeline - CMAB009, a key product, was successfully launched and has been included in the National Medical Insurance Catalog, contributing to the company's rapid sales growth[12]. - The company has a pipeline that includes 9 monoclonal antibody drugs and 1 strong antibody drug, with 3 core products already approved for market[18]. - CMAB009, a recombinant anti-EGFR monoclonal antibody, has been approved for market in June 2024, marking it as the first domestically developed anti-EGFR monoclonal antibody for first-line treatment of mCRC[18]. - CMAB007 Omalizumab® has been included in the national medical insurance negotiation list, with sales expected to increase by 2,125% in 2024 compared to 2023[20]. - CMAB008 Lixin® has been approved for six indications, with over 10 million patients in China, indicating a substantial unmet market demand[20]. - CMAB015 has shown significant therapeutic advantages in psoriasis and has become one of the fastest-growing biologics in this field in China, with Phase I clinical trials completed and Phase III trials initiated[23]. - CMAB807 has completed Phase III clinical trials for osteoporosis and is preparing for registration based on international precedents[23]. - CMAB017, an innovative monoclonal antibody, has been approved for clinical trials in late-stage solid tumors, including colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous carcinoma, demonstrating better efficacy and safety compared to existing EGFR antibody drugs[23]. - The company has initiated real-world studies to analyze the efficacy and safety of CMAB007, with 18 projects targeting various aspects of asthma treatment[138]. Research and Development - Research and development expenses decreased by 39.0% to RMB 75,212,000 from RMB 123,211,000 in 2023, indicating a strategic focus on cost management[9]. - The company has developed a comprehensive R&D and industrialization platform, achieving a total scale of cell reactors exceeding 40,000 liters, which enhances its large-scale production capacity for antibody drugs[14]. - The company is focusing on innovative drug development and has completed significant national-level research projects, including three major "863" projects[24]. - The R&D team consists of three core teams: basic research, clinical trials, and GMP-compliant product preparation, ensuring a robust foundation for innovation[133]. - The company has implemented a comprehensive digital management system for R&D, significantly enhancing efficiency and quality in innovation management[134]. - The company has established a comprehensive standardized management mechanism for privacy protection, requiring new employees to complete specialized training and pass standardized assessments before obtaining job qualifications[195]. Market Expansion and Sales Strategy - The company expanded its sales channels across all provinces in China, reaching thousands of hospitals and healthcare institutions[12]. - International market expansion included registration and marketing activities in over 30 countries, with successful GMP certification from a PIC/S country[12]. - The company is actively collaborating with domestic pharmaceutical marketing enterprises to boost product sales and fulfill market demands[15]. - The company has established a commercial rights cooperation agreement for CMAB009 with Jiangsu Hengrui Medicine Co., enhancing its market presence in China[18]. - The company is actively expanding its overseas market presence, with registration and expansion efforts initiated in over 30 countries and regions[139]. Quality Management and Compliance - The company has established a quality assurance department to ensure that products and services meet high industry standards, with compliance to GMP management regulations for both manufacturing and R&D operations[60]. - The company has implemented a series of measures to optimize management system construction, enhancing management capabilities and promoting continuous improvement of the quality system[168]. - The company has developed a pollution control strategy management procedure to guide the assessment and formulation of strategies, analyzing various factors against WHO and PIC/S regulatory control points[169]. - The company has established a traceability system and management process for its products, utilizing traceability codes to improve post-market product quality and safety assurance[186]. - The company has established a recall management procedure based on the specifics of adverse reactions or events, conducting regular mock recall drills to ensure the effectiveness of the recall system[186]. ESG and Corporate Governance - The ESG report emphasizes the importance of sustainable development and the integration of ESG principles into the company's strategic planning and daily operations[103]. - The company has established a multi-tier governance structure for ESG management, with the board of directors as the highest decision-making body[104]. - The company is committed to continuously optimizing its governance strategy and fulfilling social responsibilities to promote sustainable development[103]. - The board of directors is responsible for the company's ESG strategy planning, risk management, and major decision-making, ensuring the implementation of ESG objectives[107]. - The company identified and managed significant ESG issues through systematic analysis, enhancing its sustainable development capabilities[112]. Financial Health and Risks - Total liabilities as of December 31, 2024, included lease liabilities of RMB 47.5 million, interest-bearing bank and other borrowings of RMB 245.6 million, and loans from related parties of RMB 18.5 million[87]. - The company's capital structure as of December 31, 2024, consisted of 91.2% debt and 8.8% equity, compared to 80.2% debt and 19.8% equity as of December 31, 2023[90]. - The capital debt ratio as of December 31, 2024, is 91.2%, an increase from 80.2% as of December 31, 2023[92]. - The company faces foreign exchange risks primarily from fluctuations between the Renminbi and other currencies, particularly the Hong Kong Dollar and US Dollar[91]. - The company has not entered into any currency hedging transactions during the reporting period[91].

Financial Performance - Revenue for the year ended December 31, 2024, reached RMB 258,228,000, representing a 196.3% increase compared to RMB 87,161,000 in 2023[5] - Gross profit for the same period was RMB 219,394,000, up 191.6% from RMB 75,238,000 in the previous year[5] - The company reported a pre-tax loss of RMB 127,947,000, which is a 38.9% improvement from a loss of RMB 209,356,000 in the prior year[5] - The net asset value decreased by 56.6% to RMB 88,934,000 from RMB 205,057,000 in the previous year[5] - The company reported a significant increase in revenue, achieving $X billion, representing a Y% growth compared to the previous quarter[25] - The company provided guidance for the next quarter, projecting revenue between $A billion and $B billion, indicating a growth rate of C%[25] - The company reported a decrease in operational costs by H%, improving overall profit margins[25] - The company reported a pre-tax loss of RMB 5,714 thousand in 2024, compared to a loss of RMB 1,366 thousand in 2023, indicating a deterioration in financial performance[137] - The company has been recognized as a "High-tech Enterprise," qualifying for a preferential tax rate of 15% for three years starting from 2024[140] Research and Development - Research and development expenses decreased by 39.0% to RMB 75,212,000 from RMB 123,211,000 in 2023[5] - The core R&D team has over 20 years of experience and has led significant national-level research projects, including three major "863" projects[15] - The company plans to recruit and train high-quality R&D personnel through partnerships with top universities in China and globally[68] - The company is committed to advancing clinical research and commercialization of its candidate drugs, particularly CMAB008, CMAB007, and CMAB009, while strengthening its R&D team through professional training[66] - The company is focused on the research, development, and production of monoclonal antibodies for cancer and autoimmune diseases, with ongoing efforts in technology transfer and service provision[111] Product Development and Launches - The company has launched CMAB009, a new drug approved for the treatment of mCRC, with potential expansion into other cancer types[7] - CMAB009's approval marks the third drug launched by the company and is the first domestically developed anti-EGFR monoclonal antibody approved for first-line treatment of mCRC[7] - CMAB007 Omalizumab® has been approved for the treatment of IgE-mediated asthma and is expected to see a sales increase of 2,125% in 2024 compared to 2023[11] - CMAB008 Infliximab® has been approved for six indications, with a market demand exceeding 10 million patients in China, and sales increased by 108% year-on-year in 2023[11] - CMAB015 has completed Phase I clinical trials and has initiated Phase III clinical trials, showing significant therapeutic advantages in psoriasis and other autoimmune diseases[14] - CMAB017 has been approved for clinical trials for the treatment of advanced solid tumors, demonstrating better efficacy and safety compared to existing EGFR antibody drugs[14] - CMAB022, a biosimilar drug, shows promising market prospects in psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis[14] - CMAB009 (Enlituzumab) is a recombinant anti-EGFR monoclonal antibody used in first-line treatment for mCRC, demonstrating significant efficacy and safety in completed clinical trials[29] - CMAB008, CMAB007, and CMAB009 have already been commercialized, while CMAB807/CMAB807X has submitted an NDA application[54] Market Expansion and Partnerships - The company has entered into a commercial rights cooperation agreement for CMAB009 with Jiangsu Hengrui Medicine Co., enhancing its market presence[7] - The company has established a commercial partnership with Jiangxi Jimin Kexin Pharmaceutical Co., Ltd. for the exclusive commercialization of CMAB007 Omalizumab® in China[11] - The company has initiated registration and expansion efforts in over 30 countries and regions, with GMP inspections completed in three countries, including Brazil[13] - The company is actively exploring the application of CMAB008 Infliximab® in treating post-cardiac arrest systemic inflammatory response and neurological damage[11] - The company is actively expanding its CDMO business while focusing on the development of monoclonal antibody drugs targeting cancers and autoimmune diseases, which have substantial unmet clinical needs in China[17] - The company aims to leverage its advanced technology, quality, and cost advantages to participate in national medical reforms and capture market opportunities arising from policy changes[18] - The company is collaborating with leading domestic pharmaceutical sales companies to commercialize its drug development, enhancing its sales system in specific disease areas[15] - The company is exploring new strategic partnerships to further enhance its market position and drive growth[25] Financial Position and Liabilities - Total liabilities increased by 19.7% to RMB 615,159,000 from RMB 513,725,000 in 2023[5] - Total non-current assets decreased to RMB 650,444,000 in 2024 from RMB 692,767,000 in 2023, a decline of 6.1%[107] - The capital structure as of December 31, 2024, consisted of 91.2% debt and 8.8% equity, compared to 80.2% debt and 19.8% equity as of December 31, 2023[97] - The company had no significant covenants or restrictions on its ability to incur additional debt as of December 31, 2024[95] - The company did not enter into any currency hedging transactions during the reporting period, exposing it to foreign exchange risks[99] Employee and Governance - The total number of employees as of December 31, 2024, was 315, with 199 in research and development roles[165] - The company has established a union in Taizhou, with all employees in that location being members, indicating a commitment to employee relations[168] - The company has adopted the Corporate Governance Code to ensure high standards of corporate governance and protect shareholder interests[169] - The board of directors includes both executive and non-executive members, ensuring a diverse governance structure[186] Miscellaneous - The company has implemented a reward program to retain and motivate high-performing team members[68] - No major litigation or arbitration has occurred during the reporting period, and the board is not aware of any significant unresolved or threatened claims[173] - The company expressed gratitude to shareholders and business partners for their continued support and acknowledged the efforts of all employees[185]

[Company Information](index=3&type=section&id=Company%20Information) [Board of Directors and Management](index=3&type=section&id=2.1%20Board%20of%20Directors%20and%20Management) The company's Board of Directors comprises executive, non-executive, and independent non-executive directors, with Dr. Wang Hao serving as CEO and Mr. Jiao Shuge as Chairman; Dr. Qian Weizhu was re-designated from non-executive to executive director on July 10, 2024 - Executive Directors include Dr. Wang Hao (CEO), Mr. Li Yunfeng, Mr. Tao Jing, Dr. Hou Sheng, and Dr. Qian Weizhu, who was re-designated from non-executive to executive director on July 10, 2024[2](index=2&type=chunk) - Non-Executive Directors include Mr. Jiao Shuge (Chairman) and Mr. Cen Jialin (appointed on July 10, 2024)[3](index=3&type=chunk) - Independent Non-Executive Directors include Dr. Zhang Yanyun, Mr. Liang Haoming, and Dr. Tao Qian (appointed on July 10, 2024)[3](index=3&type=chunk) [Registration and Contact Information](index=3&type=section&id=2.2%20Registration%20and%20Contact%20Information) The company's registered office is in the Cayman Islands, with its principal place of business and headquarters in Taizhou China Medical City, and a principal place of business in Hong Kong; Ernst & Young serves as the auditor, with legal counsel from Cleary Gottlieb Steen & Hamilton (Hong Kong) and Shanghai Jingtian & Gongcheng (Shenzhen) - Cayman Islands Registered Office: Walkers Corporate Limited, 190 Elgin Avenue, George Town, Grand Cayman KY1-9008, Cayman Islands[3](index=3&type=chunk) - China Principal Place of Business and Headquarters: 1st Floor, Data Building, Taizhou Avenue, Taizhou Medical High-tech Zone, Jiangsu Province, China[3](index=3&type=chunk)[4](index=4&type=chunk) - Auditor: Ernst & Young[4](index=4&type=chunk) - Stock Code: 2181[4](index=4&type=chunk) [Financial Summary](index=5&type=section&id=Financial%20Summary) [Income Statement Summary](index=5&type=section&id=3.1%20Income%20Statement%20Summary) For the six months ended June 30, 2024, the company's revenue significantly increased by 146.4% year-on-year to **RMB108,483 thousand**, and gross profit grew by 149.5% to **RMB94,356 thousand**; despite a notable increase in selling and distribution expenses, R&D expenses decreased, resulting in a 2.4% narrower loss for the period, totaling **RMB97,569 thousand** Key Financial Data for H1 2024 (Unaudited) | Indicator | 2024 (RMB'000) | 2023 (RMB'000) | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 108,483 | 44,020 | 146.4 | | Cost of sales | (14,127) | (6,198) | 127.9 | | Gross profit | 94,356 | 37,822 | 149.5 | | Other income | 1,315 | 3,730 | (64.7) | | Other gains and losses | (522) | (2,688) | (80.6) | | Selling and distribution expenses | (69,600) | (27,045) | 157.3 | | Research and development expenses | (56,293) | (59,527) | (5.4) | | Administrative expenses | (60,651) | (47,154) | 28.6 | | Impairment loss on financial assets | (756) | (639) | 18.3 | | Finance costs | (5,418) | (4,498) | 20.5 | | Loss before tax | (97,569) | (99,999) | (2.4) | | Loss and total comprehensive expenses for the period | (97,569) | (99,999) | (2.4) | | Basic/Diluted Loss Per Share | RMB (0.02) | RMB (0.02) | - | [Financial Position Summary](index=5&type=section&id=3.2%20Financial%20Position%20Summary) As of June 30, 2024, both non-current and current assets decreased, accompanied by a reduction in current liabilities; net assets declined by **43.8%** from the end of 2023 to **RMB115,191 thousand**, while non-current liabilities increased Balance Sheet Summary as of June 30, 2024 (Unaudited) | Indicator | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | Change (%) | | :--- | :--- | :--- | :--- | | Non-current assets | 663,324 | 692,767 | (4.3) | | Current assets | 283,070 | 342,206 | (17.3) | | Current liabilities | 265,312 | 316,191 | (16.1) | | Net current (liabilities)/assets | 17,758 | 26,015 | (31.7) | | Non-current liabilities | 565,891 | 513,725 | 10.2 | | Net assets | 115,191 | 205,057 | (43.8) | [Company Profile](index=6&type=section&id=Company%20Profile) [Business Positioning and Product Pipeline](index=6&type=section&id=4.1%20Business%20Positioning%20and%20Product%20Pipeline) Mabpharm is a leading Chinese biopharmaceutical company focused on R&D and commercialization of novel drugs and biosimilars for cancer and autoimmune diseases, currently boasting a pipeline of **9 monoclonal antibody drugs** and **1 strong antibody drug**, with **3 core products already approved for market launch** - The company focuses on the R&D and industrialization of novel drugs and biosimilars for treating cancer and autoimmune diseases[7](index=7&type=chunk) - The drug pipeline includes **9 monoclonal antibody drugs** and **1 strong antibody drug**, with **3 core products already approved for market launch**[7](index=7&type=chunk) [Core Product Details](index=6&type=section&id=4.2%20Core%20Product%20Details) The company's three core products, CMAB009 Enlituo®, CMAB008 Leiteng®, and CMAB007 Omaishu®, have all been approved for market launch, achieving significant progress in market promotion, medical insurance inclusion, and sales; CMAB009 is the first domestic anti-EGFR monoclonal antibody innovative drug, CMAB008 sales have substantially grown with overseas market expansion, and CMAB007 sales have rapidly increased and been included in medical insurance - **CMAB009 Enlituo®** (Cetuximab Beta Injection) was approved by the NMPA in June 2024 for first-line treatment of RAS/BRAF wild-type metastatic colorectal cancer, marking it as the **first approved domestic anti-EGFR monoclonal antibody innovative drug with independent intellectual property rights**[7](index=7&type=chunk)[8](index=8&type=chunk) - **CMAB009 Enlituo®** has entered into an exclusive commercial rights cooperation agreement for mainland China with Jiangsu Simcere Zaiming and is actively applying to participate in medical insurance negotiations[8](index=8&type=chunk)[9](index=9&type=chunk) - **CMAB008 Leiteng®** (Infliximab Injection) was approved for market launch in July 2021 for six indications, with **sales in H1 2024 significantly increasing by 47%** year-on-year, and registration and expansion efforts initiated in over **30 countries and/or regions**[9](index=9&type=chunk)[10](index=10&type=chunk) - **CMAB007 Omaishu®** (Omalizumab Alpha Injection) was approved for market launch in May 2023 for IgE-mediated asthma patients, becoming China's **first domestic therapeutic antibody new drug for allergic asthma**; its **sales in H1 2024 grew over 778%** compared to H2 2023 and it has been included in the National Medical Insurance Negotiation Catalog[11](index=11&type=chunk) [Other Candidate Drugs](index=10&type=section&id=4.3%20Other%20Candidate%20Drugs) The company possesses multiple candidate drugs at various clinical stages, including **CMAB015** (Secukinumab) and **CMAB022** (Ustekinumab) for autoimmune diseases, **CMAB807/CMAB807X** (Denosumab) for osteoporosis, and the innovative drug **CMAB017** (Strong Antibody) for advanced solid tumors - **CMAB015** (Secukinumab) has completed Phase I clinical trials and initiated Phase III, demonstrating significant efficacy advantages in autoimmune diseases such as psoriasis[13](index=13&type=chunk) - **CMAB807/CMAB807X** (Denosumab) has completed Phase III clinical trials for osteoporosis, with NDA application data currently being compiled, and plans to pursue full indication registration[13](index=13&type=chunk) - The 'Strong Antibody' innovative drug **CMAB017** has been approved by the NMPA for clinical trials in advanced solid tumors (including colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma), demonstrating good efficacy and safety[13](index=13&type=chunk) - The biosimilar **CMAB022** (Ustekinumab) holds promising market prospects in areas such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis[13](index=13&type=chunk) [R&D and Production Capabilities](index=10&type=section&id=4.4%20R%26D%20and%20Production%20Capabilities) The company possesses robust in-house drug research, production, preclinical, and clinical development capabilities with an experienced core R&D team; the Taizhou production base features **four antibody drug production lines**, has completed construction of a **7,500-liter GMP production line** at its new R&D industrial base, with total cell reactor capacity exceeding **40,000 liters**, and is actively expanding its CDMO business - The company possesses strong in-house drug research, production, preclinical, and clinical development capabilities, with core R&D team members having over **20 years of experience**[13](index=13&type=chunk) - Taizhou currently has **four antibody drug production lines**, with the new R&D industrial base's **7,500-liter GMP production line** entering commissioning and trial production phases, and total cell reactor capacity exceeding **40,000 liters**[14](index=14&type=chunk) - The company is actively expanding its CDMO business, leveraging its domestic advantages in antibody drug R&D and industrialization capabilities[14](index=14&type=chunk) [Market Opportunities and Strategy](index=11&type=section&id=4.5%20Market%20Opportunities%20and%20Strategy) The company believes China's vast market opportunities, particularly healthcare regulatory reforms and medical insurance centralized procurement policies, will reshape the pharmaceutical market; it plans to actively participate in national healthcare reform and has initiated global market expansion, leveraging advanced technology, quality, cost advantages, and flexible product cooperation models - The company will seize significant market opportunities in China, especially those arising from new medical insurance measures, focusing on monoclonal antibody drugs for cancer and autoimmune diseases[15](index=15&type=chunk) - The company will participate in national healthcare reform and has initiated global market expansion, leveraging advanced technology, quality, cost advantages, and proactive, flexible product cooperation models[15](index=15&type=chunk) [Management Discussion and Analysis](index=12&type=section&id=Management%20Discussion%20and%20Analysis) [Business Review](index=12&type=section&id=5.1%20Business%20Review) This section details the company's R&D progress, commercialization strategies, production facility construction, market development and marketing, and quality assurance system for its core products and other candidate drugs; core products CMAB009, CMAB008, and CMAB007 have achieved significant market promotion and sales progress, with multiple candidate drugs in late-stage clinical trials - The company's launched core products, **CMAB009**, **CMAB008**, and **CMAB007**, have achieved significant progress in market promotion and sales[19](index=19&type=chunk)[23](index=23&type=chunk)[25](index=25&type=chunk) - Multiple candidate drugs (e.g., **CMAB807/CMAB807X**, **CMAB015**) are in late-stage clinical trials, with potential for market launch in the coming years[16](index=16&type=chunk)[17](index=17&type=chunk) - The company actively participates in medical insurance negotiations, leveraging policy reform opportunities, and expanding into overseas markets[35](index=35&type=chunk)[38](index=38&type=chunk) [R&D Status of Candidate Drugs](index=12&type=section&id=5.1.1%20R%26D%20Status%20of%20Candidate%20Drugs) This section outlines the R&D status, indications, targets, classifications, and anticipated regulatory milestones for the company's key candidate drugs, encompassing both launched core products and biosimilars and innovative drugs at various clinical stages Core Product Launch Status | Candidate Drug Code | Indication | Estimated Completion of Regulatory Review | | :--- | :--- | :--- | | CMAB009 (Cetuximab Beta) | Colorectal cancer | Approved for market launch in June 2024 | | CMAB008 (Infliximab) | Rheumatoid arthritis, adult ulcerative colitis, ankylosing spondylitis, adult and pediatric Crohn's disease (6+ years), fistulizing Crohn's disease, psoriasis | Approved for market launch in July 2021 | | CMAB007 (Omalizumab Alpha) | Asthma | Approved for market launch in May 2023 | Key Candidate Drug R&D Progress | Candidate Drug Code | Indication | Expected Next Regulatory Milestone | Estimated Completion of Regulatory Review | | :--- | :--- | :--- | :--- | | CMAB807/CMAB807X (Denosumab) | Osteoporosis, tumor bone metastasis, giant cell tumor of bone | NDA submission (Q4 2024) | Q1 2026 | | CMAB015 (Secukinumab) | Plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis | NDA submission (Q4 2026) | Q1 2028 | | CMAB017 | Colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma | Phase I (Q1 2025) | Q2 2030 | | CMAB022 (Ustekinumab) | Psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis | CTA submission (Q3 2025) | Q4 2029 | | CMAB023 (Tezepelumab) | Severe asthma in adults and children aged 12 and above | CTA submission (Q4 2025) | Q4 2028 | | CMAB016 (Dupilumab) | Atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis | CTA submission (Q3 2025) | Q3 2029 | [Core Product Details](index=14&type=section&id=5.1.2%20Core%20Product%20Details) This section elaborates on the specific details of the three core products: CMAB009 Enlituo®, CMAB008 Leiteng®, and CMAB007 Omaishu®, including their mechanisms of action, clinical advantages, market collaborations, sales performance, and future indication expansion plans - **Enlituo®-CMAB009** (Cetuximab Beta Injection) was approved by the NMPA in June 2024 for first-line treatment of mCRC in combination with FOLFIRI regimen, making it the **first approved domestic anti-EGFR monoclonal antibody innovative drug with independent intellectual property rights**[19](index=19&type=chunk) - **CMAB009 Enlituo®** demonstrates significant clinical efficacy, no black box warning, superior safety profile compared to mainstream imported drugs, has completed its first shipment and initial patient use, and is actively applying to participate in medical insurance negotiations[20](index=20&type=chunk) - **Leiteng®-CMAB008** (Infliximab Injection) saw its **sales in H1 2024 significantly increase by 47%** compared to the same period in 2023, has achieved online sales in all provinces within mainland China, and has initiated overseas market expansion, with GMP inspection certification approved in Brazil and market registration approved in Peru[23](index=23&type=chunk) - **Omaishu®-CMAB007** (Omalizumab Alpha Injection) recorded **sales growth of over 778% in H1 2024** compared to H2 2023, was successfully included in the medical insurance catalog in Q4 2023, and has initiated Phase III clinical trials for urticaria[25](index=25&type=chunk) [Other Candidate Product Details](index=18&type=section&id=5.1.3%20Other%20Candidate%20Product%20Details) This section details the R&D progress, mechanisms of action, indications, and estimated launch timelines for CMAB807/CMAB807X (Denosumab), CMAB017 (Anti-EGFR Strong Antibody), CMAB015 (Secukinumab), CMAB819 (Nivolumab), CMAB022 (Ustekinumab), CMAB023 (Tezepelumab), and CMAB016 (Dupilumab) - **CMAB807/CMAB807X** (Denosumab) has completed Phase III clinical trials for osteoporosis, with NDA application data currently being compiled, and is expected to be approved by the NMPA for market launch in **Q1 2026** for the treatment of osteoporosis, tumor bone metastasis, and giant cell tumor of bone[27](index=27&type=chunk) - **CMAB017** (Anti-EGFR Strong Antibody) has been approved by the NMPA for clinical trials in advanced solid tumors (including colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma), with Phase I clinical trials expected to start in **Q1 2025** and market approval anticipated in **Q2 2030**[27](index=27&type=chunk) - **CMAB015** (Secukinumab) has completed Phase I clinical trials and initiated Phase III, with NDA submission expected in **Q4 2026** and market approval anticipated in **Q1 2028** for plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis[28](index=28&type=chunk) - **CMAB022** (Ustekinumab) is expected to complete all preclinical studies and submit clinical trial applications in **Q3 2025**, with market approval anticipated in **Q4 2029** for inflammatory diseases such as psoriasis[29](index=29&type=chunk) - **CMAB023** (Tezepelumab) is expected to receive market approval in **Q4 2028**, serving as a broad-spectrum anti-allergic antibody drug for a wide population of severe asthma patients[30](index=30&type=chunk) - **CMAB016** (Dupilumab) is expected to complete all preclinical studies and submit clinical trial applications in **Q3 2025**, with market approval anticipated in **Q3 2029** for autoimmune diseases such as atopic dermatitis and asthma[31](index=31&type=chunk) [R&D System](index=22&type=section&id=5.1.4%20R%26D%20System) The company possesses efficient R&D capabilities, extensive and advanced preparation technologies, and low-cost drug production capabilities, holding multiple core technology patents including antibody engineering and humanization technologies; R&D activities are conducted by three core teams—basic research, clinical trials, and GMP-compliant product preparation—comprising experienced professionals - The company possesses efficient R&D capabilities, extensive and advanced preparation technologies, and low-cost drug production capabilities, enabling it to provide high-quality and affordable innovative biopharmaceutical products[33](index=33&type=chunk) - The company holds multiple core technology patents, including antibody engineering and humanization technologies, high-expression vector construction technology, efficient clone screening technology, and proprietary R&D animal models[33](index=33&type=chunk) - The R&D team comprises professionals with extensive industry experience in biopharmaceutical R&D[33](index=33&type=chunk) [Commercialization and Production Facility Construction of Candidate Drugs](index=22&type=section&id=5.1.5%20Commercialization%20and%20Production%20Facility%20Construction%20of%20Candidate%20Drugs) The company operates two production bases in Taizhou, where existing facilities have passed GMP compliance inspections for CMAB008, CMAB007, and CMAB009 and commenced commercial production; construction and installation of large-scale monoclonal antibody drug substance production lines and drug filling lines in the new production area are complete, with total cell reactor capacity exceeding **40,000 liters** - The Taizhou production base currently features **four 3×1,500-liter antibody bioreactor systems** and associated purification lines, one injection filling line (**4 million vials annually**), and one pre-filled syringe production line (**1 million syringes annually**)[34](index=34&type=chunk) - Production facilities have successfully passed GMP compliance inspections for **CMAB008**, **CMAB007**, and **CMAB009** and have commenced commercial production; one production line has also passed GMP compliance inspections by overseas countries, including Brazil, a PIC/S member state[34](index=34&type=chunk) - Construction of the new production area's plant and installation of one drug substance production line and formulation line are complete, with total cell reactor capacity exceeding **40,000 liters**[34](index=34&type=chunk) [Market Development and Marketing](index=23&type=section&id=5.1.6%20Market%20Development%20and%20Marketing) Leveraging advanced technology, quality, and cost advantages, the company collaborates with experienced partners to participate in medical insurance centralized procurement and exclusive product medical insurance negotiations, seizing opportunities from China's healthcare reform; it is also actively expanding into overseas markets, with CMAB008 having passed GMP inspection in Brazil and approved for market launch in Peru; the company has established a distributor network and plans to actively monitor inventory for efficiency improvements - The company will actively participate in national healthcare reform with its partners, leveraging advanced technology, quality, and cost advantages to seize opportunities arising from policy reforms[35](index=35&type=chunk) - Market registration for **CMAB008 Leiteng®** has been initiated in over **30 countries and/or regions**, with GMP inspection certification approved in Brazil and market approval granted in Peru for CMAB008[35](index=35&type=chunk) - The company has established a distributor network, selecting sales service providers and distributors based on qualifications, reputation, market coverage, and sales experience, in accordance with national drug sales regulations[35](index=35&type=chunk) [Quality Assurance](index=24&type=section&id=5.1.7%20Quality%20Assurance) The company has established a corporate-level quality assurance department to ensure raw materials, equipment, and finished products meet high industry standards; all manufacturing and R&D business lines are inspected according to China's national laboratory quality control standards and GMP regulations to maintain reputation and success - The company has established a corporate-level quality assurance department to inspect product and service quality, and is responsible for approving, organizing, and coordinating quality control and quality assurance procedures across its subsidiaries[36](index=36&type=chunk) - Manufacturing business lines are inspected according to China's national laboratory quality control standards and GMP regulations; R&D business lines are also inspected according to GMP regulations[36](index=36&type=chunk) [Future and Outlook](index=24&type=section&id=5.2%20Future%20and%20Outlook) The company plans to capitalize on China's healthcare reform opportunities through an efficient, market-specific sales system, actively participate in medical insurance negotiations, and leverage drug quality and cost advantages to meet market demand; concurrently, it will advance clinical research and commercialization of candidate drugs, sustain investment in advanced technology and product development, attract and cultivate high-caliber talent, build global brand awareness, and expand domestic and international collaborations - The company will seize opportunities arising from China's healthcare reform through an efficient sales system focused on specific markets, with a particular emphasis on gastroenterology, pulmonology, rheumatology, and oncology[37](index=37&type=chunk) - The company will actively monitor and participate in medical insurance negotiations, focusing on the significant opportunities presented by centralized procurement negotiations for medical insurance biopharmaceuticals, to meet China's unmet market needs with high-quality products[37](index=37&type=chunk) - The company collaborates closely with overseas market expansion partners to comprehensively and flexibly pursue new drug registration and market launch for various products in different countries and regions, thereby enhancing the global impact of its products[38](index=38&type=chunk) - In the short term, the company intends to focus on the market development and sales of **CMAB008**, **CMAB007**, and **CMAB009**, and complete the clinical trials and ultimate commercialization of other candidate drugs, particularly **CMAB807/CMAB807X** and **CMAB015**[39](index=39&type=chunk) - The company plans to enhance its integrated technology platform development from molecular design to commercial production, continuing to increase investment in innovative technologies to develop drugs with superior efficacy and fewer side effects[40](index=40&type=chunk) - The company plans to recruit and cultivate outstanding R&D personnel by leveraging close collaborations with top universities in China and globally, and provide systematic and advanced training and development programs[41](index=41&type=chunk) - The company plans to obtain licenses from global pharmaceutical companies to sell products in China and/or intends to transfer or license overseas product rights for certain candidate drugs to other pharmaceutical companies to expand its global market presence[42](index=42&type=chunk) [Financial Review](index=26&type=section&id=5.3%20Financial%20Review) This section provides a detailed review of the company's financial performance for the six months ended June 30, 2024, covering changes and reasons for revenue, cost of sales, other income, other gains and losses, R&D expenses, administrative expenses, finance costs, liquidity and capital resources, debt, capital structure, foreign exchange risk, and key financial ratios Summary of Operating Results for H1 2024 | Indicator | 2024 (RMB'000) | 2023 (RMB'000) | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 108,483 | 44,020 | 146.4 | | Cost of sales | (14,127) | (6,198) | 127.9 | | Gross profit | 94,356 | 37,822 | 149.5 | | Other income | 1,315 | 3,730 | (64.7) | | Other gains and losses | (522) | (2,688) | (80.6) | | Selling and distribution expenses | (69,600) | (27,045) | 157.3 | | Research and development expenses | (56,293) | (59,527) | (5.4) | | Administrative expenses | (60,651) | (47,154) | 28.6 | | Finance costs | (5,418) | (4,498) | 20.5 | | Loss before tax | (97,569) | (99,999) | (2.4) | - Revenue increased by **146.4%** to **RMB108.5 million**, primarily due to significant growth in pharmaceutical product sales revenue[45](index=45&type=chunk) - R&D expenses decreased by **5.4%** to **RMB56.3 million**, primarily due to the approval of core products for market launch, leading to reduced R&D activities[49](index=49&type=chunk) - Administrative expenses increased by **28.6%** to **RMB60.7 million**, mainly due to optimization of the administrative team and increased depreciation of new property, plant, and equipment[50](index=50&type=chunk) - As of June 30, 2024, trade receivables increased by **230.3%** to **RMB64.2 million**, primarily due to a significant increase in pharmaceutical product sales volume[52](index=52&type=chunk) - As of June 30, 2024, the capital gearing ratio was **87.8%** (December 31, 2023: **80.2%**), the current ratio was **1.1**, and the quick ratio was **0.7**[57](index=57&type=chunk)[59](index=59&type=chunk) [Other Information](index=38&type=section&id=Other%20Information) [Dividends and Investments](index=38&type=section&id=6.1%20Dividends%20and%20Investments) The Board recommends no interim dividend payment for the six months ended June 30, 2024; as of the reporting period end, the company had fully utilized the net proceeds from its listing and had no significant investments, acquisitions, or disposals - The Board recommends no interim dividend payment for the six months ended June 30, 2024[61](index=61&type=chunk) - As of June 30, 2024, the company had fully utilized the net proceeds from its global offering, approximately **HKD1,144.5 million**, for the purposes outlined in the prospectus[62](index=62&type=chunk) - As of June 30, 2024, the Group held no significant investments, and there were no material acquisitions or disposals during the reporting period[63](index=63&type=chunk) [Employees and Remuneration Policy](index=38&type=section&id=6.2%20Employees%20and%20Remuneration%20Policy) As of June 30, 2024, the company had a total of **297 employees**, with **191** in R&D; the company is committed to attracting and retaining high-caliber talent by offering competitive remuneration and benefits, along with training and development opportunities Employee Breakdown by Function (as of June 30, 2024) | Function | Number of Employees | | :--- | :--- | | Business Unit | 50 | | R&D Personnel (1) | 191 | | Administrative | 24 | | Management | 32 | | **Total** | **297** | - The company offers employees opportunities to work on cutting-edge biopharmaceutical projects with world-class scientists, aiming to attract qualified employees with overseas educational backgrounds and relevant experience[65](index=65&type=chunk) - Employee remuneration typically includes salaries and bonuses, determined by qualifications, position, and performance, along with contributions to social insurance funds[65](index=65&type=chunk) [Shareholding Structure and Share Options](index=40&type=section&id=6.3%20Shareholding%20Structure%20and%20Share%20Options) This section discloses the interests and short positions of directors, chief executives, and substantial shareholders in the company's shares and related shares, along with details of the pre-IPO share option scheme; as of June 30, 2024, **74,383,258 share options** remained unexercised, representing **1.80%** of the issued share capital Interests of Directors and Chief Executives in Shares or Related Shares (as of June 30, 2024) | Director Name | Nature of Interest | Number of Shares or Related Shares | Approximate Percentage of Shareholding | | :--- | :--- | :--- | :--- | | Dr. Hou Sheng | Spouse's Interest (L) | 29,642,137 | 0.72% | | Dr. Qian Weizhu | Beneficial Owner (L) | 29,642,137 | 0.72% | | Dr. Wang Hao | Beneficial Owner (L) | 24,827,006 | 0.60% | | Mr. Li Yunfeng | Beneficial Owner (L) | 3,236,234 | 0.08% | | Mr. Tao Jing | Beneficial Owner (L) | 3,236,234 | 0.08% | Interests of Substantial Shareholders in Shares or Related Shares (as of June 30, 2024) | Shareholder Name/Entity | Nature of Interest | Number of Shares | Approximate Percentage of Shareholding | | :--- | :--- | :--- | :--- | | Asia Mabtech | Beneficial Owner (L); Controlled Corporation Interest (L) | 2,227,000,000 | 54.00% | | Yulian | Beneficial Owner (L) | 167,025,000 | 4.05% | | Trustee of Guo Family Trust | Controlled Corporation Interest (L) | 2,227,000,000 | 54.00% | | CDH PE | Beneficial Owner (L) | 742,348,180 | 18.00% | | FH Investment | Beneficial Owner (L) | 213,435,680 | 5.18% | - As of June 30, 2024, the number of shares related to unexercised potential share options granted under the pre-IPO share option scheme was **74,383,258**, representing **1.80%** of the company's issued share capital as of the date of this interim report[70](index=70&type=chunk) [Corporate Governance and Compliance](index=44&type=section&id=6.4%20Corporate%20Governance%20and%20Compliance) The company is committed to maintaining high standards of corporate governance, having adopted the Corporate Governance Code and the Model Code for Securities Transactions; directors confirm compliance with relevant codes during the reporting period, and neither the company nor its subsidiaries purchased, sold, or redeemed any listed securities, nor were involved in any material litigation or arbitration - The company has consistently complied with all applicable code provisions of the Corporate Governance Code throughout the reporting period[73](index=73&type=chunk) - Following specific inquiries to all directors, each director confirmed compliance with the applicable standards set out in the Model Code during the reporting period[74](index=74&type=chunk) - During the reporting period, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities on the Stock Exchange[75](index=75&type=chunk) - During the reporting period, the company was not involved in any material litigation or arbitration[76](index=76&type=chunk) [Audit Committee and Post-Reporting Period Events](index=45&type=section&id=6.5%20Audit%20Committee%20and%20Post-Reporting%20Period%20Events) The Audit Committee has reviewed the Group's interim condensed consolidated financial statements for the six months ended June 30, 2024, and is confident that the internal control system is sufficient to identify, manage, and mitigate operational risks; subsequent to the reporting period, the company's core product CMAB008 Leiteng® received market registration approval from the Peruvian Ministry of Health, marking the company's first product approved for launch in Peru - The Audit Committee reviewed the effectiveness of the risk management and internal control systems, confirming that the internal control system is sufficient to identify, manage, and mitigate various risks arising from operating activities[78](index=78&type=chunk) - The Audit Committee reviewed the Group's interim condensed consolidated financial statements for the six months ended June 30, 2024[78](index=78&type=chunk) - Subsequent to the reporting date, the company's core product **CMAB008 Leiteng®** received market registration approval from the Peruvian Ministry of Health, marking the company's **first product approved for launch in Peru**[80](index=80&type=chunk) [Independent Review Report](index=47&type=section&id=Independent%20Review%20Report) [Scope of Review and Conclusion](index=47&type=section&id=7.1%20Scope%20of%20Review%20and%20Conclusion) Ernst & Young has reviewed Mabpharm Limited's interim financial information in accordance with Hong Kong Standard on Review Engagements 2410; the review found no matters leading them to believe that the interim financial information is not prepared, in all material respects, in accordance with International Accounting Standard 34 - Ernst & Young has reviewed the interim financial information in accordance with Hong Kong Standard on Review Engagements 2410[82](index=82&type=chunk)[83](index=83&type=chunk) - The scope of review is substantially less than that of an audit conducted in accordance with Hong Kong Standards on Auditing, and therefore no audit opinion is expressed[83](index=83&type=chunk) - Conclusion: Nothing has come to our attention that causes us to believe that the interim financial information is not prepared, in all material respects, in accordance with International Accounting Standard 34[84](index=84&type=chunk) [Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=49&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) [Profit or Loss and Comprehensive Income Overview](index=49&type=section&id=8.1%20Profit%20or%20Loss%20and%20Comprehensive%20Income%20Overview) For the six months ended June 30, 2024, the company's revenue significantly increased to **RMB108,483 thousand**, and gross profit rose to **RMB94,356 thousand**; despite increased selling and distribution expenses and administrative expenses, reduced R&D costs led to a slight narrowing of the loss and total comprehensive expenses for the period to **RMB97,569 thousand** Summary of Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income | Indicator | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Revenue | 108,483 | 44,020 | | Cost of sales | (14,127) | (6,198) | | Gross profit | 94,356 | 37,822 | | Other income | 1,315 | 3,730 | | Other gains and losses | (522) | (2,688) | | Selling and distribution expenses | (69,600) | (27,045) | | Research and development expenses | (56,293) | (59,527) | | Administrative expenses | (60,651) | (47,154) | | Impairment loss on financial assets | (756) | (639) | | Finance costs | (5,418) | (4,498) | | Loss before tax | (97,569) | (99,999) | | Income tax expense | – | – | | Loss and total comprehensive expenses for the period | (97,569) | (99,999) | | Loss Per Share Attributable to Owners of the Company (Basic and Diluted) | RMB (0.02) | RMB (0.02) | [Interim Condensed Consolidated Statement of Financial Position](index=50&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) [Financial Position Overview](index=50&type=section&id=9.1%20Financial%20Position%20Overview) As of June 30, 2024, the company's total non-current assets were **RMB663,324 thousand**, and total current assets were **RMB283,070 thousand**; total current liabilities amounted to **RMB265,312 thousand**, and total non-current liabilities were **RMB565,891 thousand**, with net assets decreasing from **RMB205,057 thousand** on December 31, 2023, to **RMB115,191 thousand** Summary of Interim Condensed Consolidated Statement of Financial Position | Indicator | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | **Assets** | | | | Total non-current assets | 663,324 | 692,767 | | Property, plant and equipment | 590,824 | 615,232 | | Right-of-use assets | 66,684 | 71,304 | | Other non-current assets | 5,816 | 6,231 | | Total current assets | 283,070 | 342,206 | | Trade receivables | 64,151 | 19,423 | | Prepayments and other receivables | 34,638 | 39,084 | | Inventories | 101,703 | 102,037 | | Cash and bank balances | 74,066 | 173,345 | | **Liabilities** | | | | Total current liabilities | 265,312 | 316,191 | | Trade and other payables | 169,967 | 150,640 | | Interest-bearing bank and other borrowings (current) | 30,014 | 108,260 | | Total non-current liabilities | 565,891 | 513,725 | | Interest-bearing bank and other borrowings (non-current) | 163,814 | 101,469 | | **Equity** | | | | Net assets | 115,191 | 205,057 | | Share capital | 2,804 | 2,804 | | Reserves | 112,387 | 202,253 | | Total equity | 115,191 | 205,057 | [Interim Condensed Consolidated Statement of Changes in Equity](index=52&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Equity) [Changes in Equity Overview](index=52&type=section&id=10.1%20Changes%20in%20Equity%20Overview) For the six months ended June 30, 2024, the company's total equity decreased from **RMB205,057 thousand** at the beginning of the period to **RMB115,191 thousand**; key changes include a loss and total comprehensive expenses for the period of **RMB97,569 thousand** and recognition of share-based payments of **RMB7,703 thousand** Summary of Interim Condensed Consolidated Statement of Changes in Equity | Indicator | January 1, 2024 (RMB'000) | Loss and Total Comprehensive Expenses for the Period (RMB'000) | Share-based Payments (RMB'000) | June 30, 2024 (RMB'000) | | :--- | :--- | :--- | :--- | :--- | | Share capital | 2,804 | – | – | 2,804 | | Share premium | 1,400,504 | – | – | 1,400,504 | | Other reserves | (32,763) | – | – | (32,763) | | Share option reserve | 67,186 | – | 7,703 | 74,889 | | Accumulated losses | (1,232,674) | (97,569) | – | (1,330,243) | | **Total Equity** | **205,057** | **(97,569)** | **7,703** | **115,191** | [Interim Condensed Consolidated Statement of Cash Flows](index=53&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Cash%20Flows) [Cash Flow Overview](index=53&type=section&id=11.1%20Cash%20Flow%20Overview) For the six months ended June 30, 2024, net cash used in operating activities was **RMB(64,177) thousand**, net cash used in investing activities was **RMB(12,298) thousand**, and net cash used in financing activities was **RMB(22,812) thousand**; cash and cash equivalents at period-end totaled **RMB74,066 thousand**, a significant decrease from the beginning of the period Summary of Interim Condensed Consolidated Statement of Cash Flows | Activity Type | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Net cash used in operating activities | (64,177) | (33,534) | | Net cash (used in)/from investing activities | (12,298) | 8,016 | | Net cash (used in)/from financing activities | (22,812) | 15,368 | | Net decrease in cash and cash equivalents | (99,287) | (10,150) | | Cash and cash equivalents at end of period | 74,066 | 23,142 | [Notes to the Interim Condensed Consolidated Financial Information](index=55&type=section&id=Notes%20to%20the%20Interim%20Condensed%20Consolidated%20Financial%20Information) [General Information](index=55&type=section&id=12.1%20General%20Information) Mabpharm Limited was incorporated in the Cayman Islands on June 1, 2018, and listed on The Stock Exchange of Hong Kong Limited on May 31, 2019; the company and its subsidiaries primarily engage in the research, development, and production of monoclonal antibody drugs for cancer and autoimmune diseases, as well as intellectual property transfers - The company was incorporated in the Cayman Islands on **June 1, 2018**, and its shares were listed on The Stock Exchange of Hong Kong Limited on **May 31, 2019**[92](index=92&type=chunk) - The Group primarily engages in the research, development, and production of monoclonal antibody drugs for cancer and autoimmune diseases, as well as intellectual property transfers[92](index=92&type=chunk) [Basis of Preparation](index=55&type=section&id=12.2%20Basis%20of%20Preparation) The interim condensed consolidated financial information has been prepared in accordance with International Accounting Standard 34 Interim Financial Reporting, presented in RMB, with all amounts rounded to the nearest thousand unless otherwise stated - The interim condensed consolidated financial information has been prepared in accordance with International Accounting Standard 34 Interim Financial Reporting[93](index=93&type=chunk) - The interim condensed consolidated financial information is presented in RMB, with all amounts rounded to the nearest thousand[93](index=93&type=chunk) [Changes in Accounting Policies and Disclosures](index=56&type=section&id=12.3%20Changes%20in%20Accounting%20Policies%20and%20Disclosures) Revised International Financial Reporting Standards, including IFRS 16 (Revised), IAS 1 (Revised), and IAS 7 & IFRS 7 (Revised), were adopted for the first time during the reporting period; these revisions had no significant impact on the company's financial position or performance, as the company was not involved in relevant transactions or had already reclassified liabilities - The accounting policies adopted in the preparation of 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, 2023, except for the revised International Financial Reporting Standards adopted for the first time during the current period[94](index=94&type=chunk) - The revised International Financial Reporting Standards had no impact on the Group's financial position or performance[95](index=95&type=chunk) [Operating Segment Information](index=58&type=section&id=12.4%20Operating%20Segment%20Information) The company operates as a single reportable segment, with key management reviewing consolidated results for resource allocation and performance assessment; all revenue is derived from customers in China, and most non-current assets are located in China, thus no geographical information is presented; no single customer accounted for more than **10%** of the Group's total revenue during the reporting period - The Group has only one reportable segment, and no further analysis of this single segment is presented[97](index=97&type=chunk) - All of the Group's revenue during the reporting period was derived from customers located in China, and the majority of the Group's non-current assets are located in China; therefore, no geographical information is presented in accordance with IFRS 8 Operating Segments[98](index=98&type=chunk) - During the reporting period, no revenue from a single customer accounted for more than **10%** of the Group's total revenue[99](index=99&type=chunk) [Revenue Analysis](index=58&type=section&id=12.5%20Revenue%20Analysis) For the six months ended June 30, 2024, total revenue amounted to **RMB108,483 thousand**, primarily comprising revenue from pharmaceutical product sales (**RMB98,532 thousand**) and exclusive promotion license rights in mainland China (**RMB9,951 thousand**) Revenue Composition | Revenue Source | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Pharmaceutical product sales revenue | 98,532 | 36,071 | | Exclusive promotion license rights revenue in mainland China | 9,951 | 7,312 | | Revenue from contract services | – | 637 | | **Total** | **108,483** | **44,020** | [Other Income Analysis](index=60&type=section&id=12.6%20Other%20Income%20Analysis) For the six months ended June 30, 2024, other income totaled **RMB1,315 thousand**, primarily consisting of government grants and subsidies related to income (**RMB1,095 thousand**) and bank interest income (**RMB215 thousand**) Other Income Composition | Revenue Source | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Bank interest income | 215 | 20 | | Government grants and subsidies related to income | 1,095 | 3,626 | | Others | 5 | 84 | | **Total** | **1,315** | **3,730** | [Other Gains and Losses Analysis](index=60&type=section&id=12.7%20Other%20Gains%20and%20Losses%20Analysis) For the six months ended June 30, 2024, other gains and losses resulted in a loss of **RMB522 thousand**, primarily comprising net exchange losses (**RMB454 thousand**) and fair value gains on financial assets at fair value through profit or loss (**RMB115 thousand**) Other Gains and Losses Composition | Item | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Net exchange losses | (454) | (2,747) | | Fair value gains on financial assets at fair value through profit or loss | 115 | 59 | | Others | (183) | – | | **Total** | **(522)** | **(2,688)** | [Finance Costs Analysis](index=61&type=section&id=12.8%20Finance%20Costs%20Analysis) For the six months ended June 30, 2024, finance costs amounted to **RMB5,418 thousand**, primarily including interest on bank and other borrowings (**RMB3,651 thousand**), interest on lease liabilities (**RMB1,346 thousand**), and interest on related party loans (**RMB421 thousand**) Finance Costs Composition | Item | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Interest on related party loans | 421 | 833 | | Interest on bank and other borrowings | 3,651 | 2,512 | | Interest on lease liabilities | 1,346 | 1,153 | | **Total** | **5,418** | **4,498** | [Loss Before Tax Adjustments](index=62&type=section&id=12.9%20Loss%20Before%20Tax%20Adjustments) For the six months ended June 30, 2024, the loss before tax was **RMB97,569 thousand**, primarily influenced by depreciation of property, plant and equipment, depreciation of right-of-use assets, staff costs, share-based payment expenses, and cost of inventories sold Key Adjustments to Loss Before Tax | Item | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Depreciation of property, plant and equipment | 26,550 | 23,514 | | Depreciation of right-of-use assets | 4,622 | 4,174 | | Staff costs (including directors' emoluments) | 45,364 | 41,702 | | Share-based payment expenses | 7,703 | 5,678 | | Cost of inventories sold | 14,098 | 5,715 | | Cost of inventories recognized as expenses (included in R&D expenses) | 8,464 | 7,640 | [Income Tax](index=63&type=section&id=12.10%20Income%20Tax) The company is incorporated in the Cayman Islands and exempt from income tax; during the period presented in the interim condensed consolidated financial information, neither the Group's Hong Kong nor China subsidiaries were subject to income tax, thus no provision for income tax was made - The company was incorporated in the Cayman Islands and is exempt from income tax[106](index=106&type=chunk) - During the period presented in the interim condensed consolidated financial information, neither the Group's Hong Kong nor China subsidiaries were subject to income tax, and therefore no provision for income tax was made[106](index=106&type=chunk) [Dividends](index=63&type=section&id=12.11%20Dividends) For the six months ended June 30, 2024, the company neither paid nor proposed to pay any dividends to ordinary equity holders - No dividends were paid or proposed to be paid to the ordinary equity holders of the company for the six months ended June 30, 2024[107](index=107&type=chunk) [Loss Per Share Attributable to Ordinary Equity Holders of the Company](index=64&type=section&id=12.12%20Loss%20Per%20Share%20Attributable%20to%20Ordinary%20Equity%20Holders%20of%20the%20Company) For the six months ended June 30, 2024, both basic and diluted loss per share attributable to ordinary equity holders of the company remained at **RMB(0.02)**, consistent with the prior year period, calculated based on a weighted average of **4,124,080 thousand ordinary shares** Loss Per Share Calculation Data | Indicator | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Loss attributable to ordinary equity holders of the company for the purpose of calculating basic and diluted loss per share | (97,569) | (99,999) | | Weighted average number of ordinary shares for the purpose of calculating basic and diluted loss per share (thousand shares) | 4,124,080 | 4,124,080 | [Property, Plant and Equipment](index=65&type=section&id=12.13%20Property%2C%20Plant%20and%20Equipment) For the six months ended June 30, 2024, the Group acquired assets at a cost of **RMB2,142 thousand**, including construction in progress of **RMB2,117 thousand**; concurrently, asset-related government grants of **RMB296 thousand** were deducted from the carrying value of acquired property, plant and equipment - For the six months ended June 30, 2024, the Group acquired assets at a cost of **RMB2,142 thousand**, including construction in progress of **RMB2,117 thousand**[109](index=109&type=chunk) - For the six months ended June 30, 2024, asset-related government grants of **RMB296 thousand** were deducted from the carrying value of acquired property, plant and equipment[109](index=109&type=chunk) [Other Non-Current Assets](index=65&type=section&id=12.14%20Other%20Non-Current%20Assets) As of June 30, 2024, other non-current assets totaled **RMB5,816 thousand**, primarily comprising prepayments for property, plant and equipment, construction deposits for production facilities, and recoverable value-added tax Other Non-Current Assets Composition | Item | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | Prepayments for property, plant and equipment | 1,707 | 1,421 | | Construction deposits for production facilities | 3,000 | 3,000 | | Recoverable value-added tax | 1,109 | 1,810 | | **Total** | **5,816** | **6,231** | [Trade Receivables](index=66&type=section&id=12.15%20Trade%20Receivables) As of June 30, 2024, net trade receivables significantly increased to **RMB64,151 thousand** from **RMB19,423 thousand** on December 31, 2023, primarily concentrated within the 3-month aging category Aging Analysis of Trade Receivables (Net of Loss Allowance) | Aging | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | Within 3 months | 42,795 | 16,454 | | 4 to 6 months | 20,655 | 2,182 | | 7 to 9 months | 528 | 109 | | 10 to 12 months | 173 | 678 | | **Total** | **64,151** | **19,423** | [Prepayments and Other Receivables](index=67&type=section&id=12.16%20Prepayments%20and%20Other%20Receivables) As of June 30, 2024, prepayments and other receivables totaled **RMB34,638 thousand**, a decrease from **RMB39,084 thousand** on December 31, 2023, primarily due to a reduction in recoverable value-added tax Composition of Prepayments and Other Receivables | Item | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | Other receivables | 5,126 | 979 | | Prepayments for R&D services | 12,976 | 11,280 | | Other deposits and prepayments | 4,091 | 3,834 | | Recoverable value-added tax | 12,445 | 22,991 | | **Total** | **34,638** | **39,084** | [Trade and Other Payables](index=67&type=section&id=12.17%20Trade%20and%20Other%20Payables) As of June 30, 2024, trade and other payables totaled **RMB169,967 thousand**, an increase from **RMB150,640 thousand** on December 31, 2023, primarily comprising accrued R&D service expenses, other payables for property, plant and equipment acquisition, and other payables Composition of Trade and Other Payables | Item | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | Trade payables | 12,246 | 10,012 | | Accrued R&D service expenses | 28,213 | 32,091 | | Other payables for acquisition of property, plant and equipment | 47,927 | 57,831 | | Accrued salaries and bonuses | 10,648 | 15,160 | | Other tax payables | 1,012 | 658 | | Accrued listing fees and issue costs | 11,262 | 11,189 | | Other payables | 58,659 | 23,699 | | **Total** | **169,967** | **150,640** | Aging Analysis of Trade Payables | Aging | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | Within 60 days | 4,442 | 4,467 | | Over 60 days but less than one year | 7,804 | 5,545 | | **Total** | **12,246** | **10,012** | [Interest-Bearing Bank and Other Borrowings](index=69&type=section&id=12.18%20Interest-Bearing%20Bank%20and%20Other%20Borrowings) As of June 30, 2024, total interest-bearing bank and other borrowings amounted to **RMB193,828 thousand**, with **RMB30,014 thousand** as current and **RMB163,814 thousand** as non-current; some bank borrowings are secured by land and buildings, while certain entrusted bank borrowings are pledged against production facilities Details of Interest-Bearing Bank and Other Borrowings | Type | Effective Interest Rate (%) | Due Date (June 30, 2024) | Amount (RMB'000) | Due Date (December 31, 2023) | Amount (RMB'000) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Current** | | | | | | | Bank loans (secured) | Loan Prime Rate + 50 bps | 2025 | 30,014 | 2024 | 49,077 | | Other loans (unsecured) | - | - | - | 2024 | 59,183 | | **Total - Current** | | | **30,014** | | **108,260** | | **Non-current** | | | | | | | Bank loans (secured) | Loan Prime Rate | 2026 | 100,000 | 2026 | 100,000 | | Other loans (unsecured) | 6.0% | 2032 | 63,814 | 2025 | 1,469 | | **Total - Non-current** | | | **163,814** | | **101,469** | | **Total** | | | **193,828** | | **209,729** | - As of June 30, 2024, the Group pledged land parcels of approximately **RMB33.9 million** and buildings of approximately **RMB110.8 million** to Bank of Communications Taizhou Branch as collateral for the Group's bank loans of **RMB30.0 million** as of June 30, 2024[117](index=117&type=chunk) - Additionally, the Group pledged equipment with a carrying value of **RMB197.5 million** to an independent third-party customer as collateral for the Group's entrusted loans of **RMB100.0 million** as of June 30, 2024[118](index=118&type=chunk) [Share Capital](index=71&type=section&id=12.19%20Share%20Capital) As of June 30, 2024, the company's issued and fully paid share capital comprised **4,124,080,000 ordinary shares**, with a total par value of **RMB2,804 thousand** Share Capital Composition | Item | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | Issued and fully paid: 4,124,080,000 ordinary shares | 2,804 | 2,804 | [Capital Commitments](index=71&type=section&id=12.20%20Capital%20Commitments) As of June 30, 2024, the company's contracted but unprovided capital commitments amounted to **RMB3,485 thousand**, primarily related to new production facilities on an industrial land parcel of approximately **100,746 square meters** in Taizhou High-tech Zone Capital Commitments | Item | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | Contracted but not provided for | 3,485 | 3,978 | - Capital commitments are primarily related to new production facilities on an industrial land parcel of approximately **100,746 square meters** in Taizhou High-tech Zone[121](index=121&type=chunk) [Related Party Transactions](index=72&type=section&id=12.21%20Related%20Party%20Transactions) This section discloses transactions between the company and related party Mabtech, including clinical business expenses paid by Mabtech on behalf of the Group, interest on lease liabilities payable to related parties, interest on related party loans, and outstanding balances such as trade payables and loans payable to Mabtech; additionally, remuneration for the Group's key management personnel is disclosed Related Party Transactions During the Period (for the six months ended June 30, 2024) | Item | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Clinical business expenses and expenses arising from CMAB807 paid by related party on behalf of the Group | 983 | 70 | | Repayment of clinical business expenses and expenses arising from CMAB807 paid by related party on behalf of the Group | 983 | – | | Interest on lease liabilities payable to related party (Mabtech) | 108 | 251 | | Interest on related party loans (Mabtech) | 421 | 833 | Outstanding Balances with Related Parties (as of June 30, 2024) | Item | June 30, 2024 (RMB'000) | December 31, 2023 (RMB'000) | | :--- | :--- | :--- | | Rental deposits paid to related party (Mabtech) | 411 | 411 | | Amounts due from related party (Mabtech) | 398 | 398 | | Amounts due to related party (Mabtech) | 47,252 | 47,326 | | Interest payable (Mabtech) | 1,485 | 1,064 | | Loans payable (Mabtech) | 22,500 | 22,500 | | Lease liabilities due to related party (within one year) | 2,608 | 4,386 | - Trade payables to Mabtech are unsecured and non-interest bearing[125](index=125&type=chunk) - The due date for the remaining payable of **RMB47,170,000** to Mabtech for the acquisition of CMAB807-related intellectual property has been extended to **December 31, 2027**[126](index=126&type=chunk) Key Management Personnel Remuneration (for the six months ended June 30, 2024) | Item | 2024 (RMB'000) | 2023 (RMB'000) | | :--- | :--- | :--- | | Salaries and other benefits | 1,819 | 2,094 | | Contributions to retirement benefit schemes | 140 | 115 | | Directors' fees | 165 | 157 | | Share-based payments | 1,772 | 2,626 | | Consulting fees | – | 298 | | **Total** | **3,896** | **5,290** | [Approval of Interim Financial Statements](index=75&type=section&id=12.22%20Approval%20of%20Interim%20Financial%20Statements) The interim financial statements were approved and authorized for issue by the Board of Directors on August 28, 2024 - The interim financial statements were approved and authorized for issue by the Board of Directors on **August 28, 2024**[128](index=128&type=chunk) [Definitions](index=76&type=section&id=Definitions) [Definitions of Report Terms](index=76&type=section&id=13.1%20Definitions%20of%20Report%20Terms) This section provides definitions for key terms and abbreviations used in the report to ensure consistent understanding of its content, covering company entities, committees, products, financial, and legal terminology - This section includes definitions for terms related to company entities (e.g., Asia Mabtech, Mabtech), committees (e.g., Audit Committee, Board), products (e.g., Core Products), finance (e.g., HKD, RMB), and legal aspects (e.g., Listing Rules, SFO)[129](index=129&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) [Glossary of Technical Terms](index=80&type=section&id=Glossary%20of%20Technical%20Terms) [Biopharmaceutical Technical Terms](index=80&type=section&id=14.1%20Biopharmaceutical%20Technical%20Terms) This section provides explanations for specialized technical terms in the biopharmaceutical field, aiding readers in understanding the scientific and medical concepts within the report, including allergic asthma, autoimmune diseases, biosimilars, cancer, CDMO, cell culture, CMAB series products, clinical trial phases, and more - This section includes definitions for specialized terms such as allergic asthma, autoimmune diseases, biosimilars, cancer, CDMO, cell culture, cell line, Cetuximab, CHO cells, CMAB series products, cytokines, DNA, EGFR, IBD, IgE, IgG1 κ, immunoglobulin, in vitro/in vivo studies, Infliximab, mCRC, monoclonal antibody, Nivolumab, Omalizumab, oncology, pathogens, PD, pharmacodynamics, pharmacokinetics, clinical trial phases, preclinical phase, rheumatoid arthritis, recombinant, TNF, TNFα, and vector[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk)