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)

Financial Performance - Revenue for the six months ended June 30, 2024, reached RMB 108,483 thousand, a significant increase of 146.4% compared to RMB 44,020 thousand for the same period in 2023[2] - Gross profit for the same period was RMB 94,356 thousand, reflecting a 149.5% increase from RMB 37,822 thousand year-over-year[2] - The company reported a pre-tax loss of RMB 97,569 thousand, a slight improvement of 2.4% compared to a loss of RMB 99,999 thousand in the prior period[2] - The company reported a net loss of RMB 97,569 thousand for the six months ended June 30, 2024, compared to a loss of RMB 99,999 thousand for the same period in 2023, showing a slight improvement in performance[68] - The company’s total equity decreased to RMB 115,191 thousand as of June 30, 2024, from RMB 205,057 thousand as of December 31, 2023, representing a decline of approximately 43.8%[68] - The company incurred financial costs of RMB 5,418 thousand for the six months ended June 30, 2024, compared to RMB 4,498 thousand for the same period in 2023, indicating an increase of about 20.4%[69] - The company reported a net foreign exchange loss of RMB (454,000) for the six months ended June 30, 2024, compared to a loss of RMB (2,747,000) in the same period of 2023, showing an improvement of 83.5%[83] Assets and Liabilities - Non-current assets totaled RMB 663,324 thousand, down 4.3% from RMB 692,767 thousand as of December 31, 2023[2] - Current assets decreased by 17.3% to RMB 283,070 thousand from RMB 342,206 thousand at the end of the previous year[2] - Total liabilities decreased by 16.1% to RMB 265,312 thousand from RMB 316,191 thousand at the end of the previous year, reflecting improved financial management[2] - The company’s total current liabilities decreased to RMB 265,312 thousand from RMB 316,191 thousand as of December 31, 2023, representing a reduction of approximately 16.2%[66] - The company’s non-current liabilities increased to RMB 565,891 thousand as of June 30, 2024, from RMB 513,725 thousand as of December 31, 2023, marking an increase of about 10.1%[66] Research and Development - The focus of research and development is on monoclonal antibodies targeting cancers and autoimmune diseases, addressing significant unmet clinical needs in China[11] - The company has initiated the development of a series of new antibody drugs targeting autoimmune diseases and/or tumor diseases, aiming to expand its product pipeline and ensure long-term growth[30] - CMAB015 (Sikukiyu antibody) has shown significant efficacy in treating psoriasis and has entered Phase III clinical trials[10] - CMAB807/CMAB807X (Dazhu antibody) has completed Phase III clinical trials for osteoporosis and is preparing NDA submission[10] - CMAB017 has received approval for clinical trials in late-stage solid tumors, including colorectal and head and neck cancers[10] Product Development and Approvals - The company has received approval for its core product CMAB009 for the treatment of metastatic colorectal cancer, marking a significant milestone in its product pipeline[4] - CMAB009 is expected to expand its indications to include pancreatic cancer and head and neck squamous cell carcinoma, indicating potential for further market growth[5] - CMAB008类停® has been approved for six indications, with over 10 million patients in China, and sales in the first half of 2024 increased by 47% compared to the same period in 2023[7] - CMAB007奧邁舒® has been approved for allergic asthma treatment and has completed procurement registration across all provincial platforms in China, covering thousands of hospitals and pharmacies[9] - CMAB007奧邁舒® sales in the first half of 2024 surged over 778% compared to the second half of 2023, following its inclusion in the national medical insurance list[9] Market Expansion and Strategy - The company has initiated registration and expansion efforts in over 30 countries, with GMP inspections completed in three countries, including Brazil[8] - The company aims to leverage China's healthcare reforms to capture market opportunities and enhance its competitive edge in antibody drug development[11] - The company is actively applying for participation in exclusive drug reimbursement negotiations with the medical insurance department to expedite CMAB009's market access[17] - The company plans to launch CMAB008 in over 30 countries, having completed GMP inspections in three countries, including Brazil and Peru[34] Financial Management and Governance - The company has established a dedicated quality assurance department to ensure that products and services meet high industry standards and requirements[36] - The company maintains a high level of corporate governance to protect shareholder interests and enhance corporate value[113] - The independent auditor, Ernst & Young, reviewed the interim financial information for the six months ending June 30, 2024, ensuring the effectiveness of the risk management and internal control systems[118] Employee and Talent Management - The company intends to attract and retain high-quality talent through partnerships with top universities and systematic training programs[41] - The company has a total of 297 employees, with 191 in R&D roles[111]

Employee Safety and Satisfaction - The company reported zero employee injury incidents and zero days lost due to work-related injuries for the year 2023[1]. - The company has implemented employee satisfaction surveys post-training to adjust future training needs based on feedback[3]. - The company focuses on employee development and satisfaction, conducting employee satisfaction surveys to gauge and improve workplace conditions[1]. Financial Performance - For the fiscal year 2023, total revenue reached RMB 87,161 thousand, representing a 55.9% increase from RMB 55,918 thousand in 2022[45]. - Gross profit for 2023 was RMB 75,238 thousand, an 85.6% increase from RMB 40,543 thousand in 2022[45]. - The company reported a net loss of RMB 209,356 thousand for 2023, a slight decrease of 0.7% compared to a loss of RMB 210,819 thousand in 2022[45]. - Operating revenue for 2023 reached RMB 87,161 thousand, an increase of 55.9% from RMB 55,918 thousand in 2022[131]. - Pharmaceutical sales revenue for 2023 reached RMB 69,923,000, an increase from RMB 21,544,000 in 2022, representing a growth of 224.5%[158]. - Exclusive promotion rights income in mainland China was RMB 16,601,000 for 2023, up from RMB 10,613,000 in 2022, marking a growth of 56.0%[158]. - Total revenue for 2023 amounted to RMB 87,161,000, compared to RMB 55,918,000 in 2022, reflecting a growth of 55.7%[158]. Research and Development - The company is developing a series of new antibody drugs targeting autoimmune diseases and/or tumors, with expectations to complete several drug screenings and preclinical animal trials[11]. - Research and development expenses for 2023 were RMB 123,211 thousand, a decrease of 16.7% from RMB 147,906 thousand in 2022[45]. - The company has a pipeline of nine monoclonal antibody drugs and one strong antibody drug, with CMAB807 and CMAB015 expected to drive future growth[50]. - The company focuses on developing monoclonal antibody drugs targeting cancer and autoimmune diseases, addressing significant unmet clinical needs in China[78]. - The core R&D team has over 20 years of experience and has led significant national research projects, including three "863" program projects[77]. Product Development and Market Expansion - CMAB022, a biosimilar drug candidate, is projected to complete all preclinical studies by Q2 2025 and initiate Phase I clinical trials in Q1 2026, with plans for market approval by Q4 2029[18]. - The development of CMAB007, a new drug for treating IgE-mediated asthma, was approved for market entry in mainland China, with a significant market potential due to its applicability to various allergic conditions[38]. - The company submitted a New Drug Application (NDA) for CMAB009, a treatment for colorectal cancer, in March 2023, which is expected to be the first domestically developed anti-EGFR monoclonal antibody for mCRC treatment in China[39]. - CMAB007 has been included in the national medical insurance catalog and is expected to see rapid market introduction and sales growth in 2024[55]. - CMAB009 is expected to be approved for market launch in Q2 2024, targeting mCRC treatment and potentially expanding to other cancers such as pancreatic and cervical cancer[57]. - The company is actively collaborating with international partners to expand its product registration and market presence globally, particularly in antibody drugs[20]. - The company has initiated registration and expansion efforts in over 30 countries and regions, completing GMP inspections in three countries[53]. Financial Position and Liabilities - As of December 31, 2023, the company had lease liabilities of RMB 50.3 million and bank borrowings of RMB 209.7 million, with no significant covenants restricting its borrowing capacity[24]. - The current ratio remained stable at 1.1, while the quick ratio improved to 0.8 from 0.5 in 2022[146]. - Total current assets increased by 70.2% to RMB 342,206 thousand in 2023, compared to RMB 201,120 thousand in 2022[37]. - Total non-current assets decreased by 3.3% to RMB 692,767 thousand in 2023, down from RMB 716,401 thousand in 2022[37]. - The company's debt-to-capital ratio rose to 80.2% in 2023, compared to 56.3% in 2022[172]. Corporate Governance and Compliance - The company emphasizes the importance of a robust corporate governance structure and internal risk management to ensure sustainable and healthy development[190]. - The company has implemented a comprehensive risk management strategy, establishing a three-tier risk governance framework to identify, assess, and respond to various operational risks[194]. - The company strictly adheres to national laws and regulations, including anti-money laundering and anti-corruption laws, to foster a culture of integrity and diligence[196]. - The company conducts regular anti-corruption training for all employees, ensuring awareness and compliance with ethical standards[197]. - The company is committed to maintaining high standards of corporate governance to support its ongoing and stable growth[190]. Production Capacity and Facilities - The production facility in Taizhou has a total area of 30,000 square meters, equipped to produce 4 million vials annually and 1 million pre-filled syringes[19]. - The company has completed the construction of a new 5,000-liter GMP production line in Taizhou, which is currently in trial production and GMP registration stages, with a total bioreactor capacity exceeding 40,000 liters[60]. - The company has established a quality assurance department to ensure that products and services meet high industry standards and requirements[99]. - The company has implemented a comprehensive quality control system throughout the lifecycle of its facilities and equipment[99]. Market Strategy and Sales - The company aims to enhance its global competitiveness in antibody drugs due to the unmet market demand, especially in PIC/S member countries[20]. - The company plans to leverage its advanced technology and cost-effective production to capture unmet market demand in China[50]. - The company is actively expanding its CDMO business while ensuring that its own product development remains unaffected[60]. - The company plans to enhance its sales network efficiency by actively monitoring distributor inventory levels[123]. - The sales team will focus on specific markets such as gastroenterology, respiratory diseases, rheumatology, and oncology to promote products effectively[125].

Product Development and Approval - CMAB008类停® achieved significant sales growth, covering over 1,000 hospitals and sales terminals in China, with procurement completed across all provincial and GPO platforms[2]. - CMAB807 (dazhuo monoclonal antibody) is expected to receive approval from the National Medical Products Administration by Q4 2025 for osteoporosis treatment[5]. - CMAB022, a biosimilar to ustekinumab, is projected to complete all preclinical studies by Q2 2025 and initiate Phase I clinical trials in Q1 2026[7]. - CMAB009, a recombinant anti-EGFR monoclonal antibody, has shown significant efficacy and safety in clinical trials compared to traditional anti-EGFR monoclonal antibodies[4]. - CMAB007 (Omaizhu®) received approval from the National Medical Products Administration in May 2023 for the treatment of IgE-mediated asthma, marking it as the first domestically produced monoclonal antibody for this indication in China[194]. - CMAB009 is expected to be approved for market entry in Q2 2024, aiming to be the first domestically developed anti-EGFR monoclonal antibody for mCRC treatment in China, potentially benefiting hundreds of thousands of patients[195]. - CMAB807X (Dizhu monoclonal antibody) is anticipated to receive approval for treating tumor bone metastasis by Q4 2028, following successful preclinical studies[188]. - CMAB819 (Nabulizumab) is currently undergoing Phase I clinical trials, with expectations for market approval by Q4 2028 for treating metastatic non-small cell lung cancer, hepatocellular carcinoma, and head and neck squamous cell carcinoma[189]. - The expected regulatory review completion dates for various products range from Q4 2026 to Q1 2030, indicating a robust pipeline for future growth[1]. Financial Performance - The company reported a gross profit of RMB 75.2 million in 2023, up from RMB 40.5 million in 2022, reflecting improved operational efficiency[35]. - The company’s total liabilities for interest-bearing bank and other borrowings increased from RMB 84.7 million in 2022 to RMB 209.7 million in 2023[29]. - The company reported a pre-tax loss of RMB 209.4 million in 2023, slightly improved from a loss of RMB 210.8 million in 2022[35]. - The company reported a net loss of RMB 1,366,000 for the year ended December 31, 2023, compared to a net loss of RMB 4,682,000 in 2022, indicating a significant improvement[54]. - Revenue for the reporting period was approximately RMB 14,151,000, derived from exclusive promotion rights with a single customer, compared to RMB 23,761,000 in the previous year[87]. - The company reported a loss attributable to ordinary equity holders of RMB 209,356 thousand in 2023, compared to a loss of RMB 210,819 thousand in 2022[104]. - The company’s operating revenue for the year ended December 31, 2023, was RMB 87,161,000, an increase of 55.9% compared to RMB 55,918,000 in 2022[169]. - Gross profit reached RMB 75,238,000, representing an 85.6% increase from RMB 40,543,000 in the previous year[169]. - Research and development expenses decreased by 16.7% to RMB 123,211,000 from RMB 147,906,000 in 2022[169]. Market Expansion and Strategy - The company has initiated registration work for CMAB008类停® in over 30 countries, with GMP inspections completed in three countries, including Brazil[2][11]. - The company aims to focus on the market development and sales of CMAB008, CMAB007, and CMAB009, while completing clinical trials and commercialization of CMAB807 and CMAB015[14]. - The company plans to establish a sales team in China with a focus on gastrointestinal, respiratory, rheumatology, and oncology markets to enhance product promotion and accumulate practical experience in antibody drug applications[13]. - The company has established partnerships with domestic and international pharmaceutical companies to seek opportunities for collaboration and expand market share beyond China[16]. - The company is actively monitoring and participating in medical insurance negotiations to leverage opportunities arising from policy reforms in the Chinese pharmaceutical market[13]. - The rapid development of the Chinese pharmaceutical market is expected to significantly reshape the market dynamics, with the company aiming to participate in national healthcare reforms and seize opportunities from policy changes[199]. - The company has initiated global market expansion and successfully passed GMP inspection certification from PIC/S member countries, accelerating the registration and launch of its drugs in international markets[199]. Research and Development - The company possesses advanced R&D capabilities and cost-effective production capacity, enabling it to provide high-quality innovative biopharmaceutical products[9]. - The company emphasizes a strong internal capability in drug research, production, and clinical development, leveraging partnerships with leading domestic sales companies to enhance commercialization efforts[197]. - The company has a pipeline of 9 monoclonal antibody drugs and 1 strong antibody drug, with 3 core products currently in development[193]. - The company is focusing on developing monoclonal antibody drugs targeting cancer and autoimmune diseases, addressing significant unmet clinical needs in China[176]. - The company has established four antibody drug production lines in Taizhou and completed the construction of a new 5,000-liter GMP production line, which is currently in trial production and process validation stages[198]. - The total scale of the company's cell reactors has exceeded 40,000 liters, providing a solid foundation in equipment, technology, and quality for future competitive advantages in the healthcare procurement negotiations[198]. Human Resources and Corporate Governance - The company is committed to attracting and nurturing high-quality talent to support its rapid growth[15]. - As of December 31, 2023, the company had a total of 347 employees, including 223 in R&D, indicating a strong focus on research and development[115]. - The company maintains high levels of corporate governance to protect shareholder interests and enhance corporate value[138]. - The audit committee consists of two independent non-executive directors and one non-executive director, ensuring compliance with listing rules[143]. - The company has established a union in Taizhou, representing all employees as of December 31, 2023, ensuring good working relationships with staff[137]. - There were no significant difficulties in hiring employees during the reporting period[137]. Assets and Liabilities - Non-current assets decreased from RMB 716,401,000 in 2022 to RMB 692,767,000 in 2023, reflecting a decline of approximately 3.3%[66]. - Current assets increased substantially from RMB 201,120,000 in 2022 to RMB 342,206,000 in 2023, representing a growth of about 70.1%[66]. - The company's cash and bank balances rose significantly from RMB 33,568,000 in 2022 to RMB 173,345,000 in 2023, an increase of approximately 416.5%[66]. - Total current liabilities increased from RMB 188,401,000 in 2022 to RMB 316,191,000 in 2023, marking a rise of about 68.0%[66]. - The company has lease liabilities of RMB 50.3 million and interest-bearing bank and other borrowings of RMB 209.7 million as of December 31, 2023[59]. - Trade receivables increased from RMB 9,532,000 in 2022 to RMB 19,423,000 in 2023, showing a growth of approximately 104.4%[66]. - The company has a strict credit control system in place, with a credit period for major customers generally ranging from 30 to 90 days, and no significant credit concentration risk identified[109]. - The total trade receivables for the year 2023 amounted to RMB 19,423,000, compared to RMB 9,532,000 in 2022, representing a growth of 104.5%[110]. Miscellaneous - The company has not been involved in any major litigation or arbitration during the reporting period[142]. - The company has not purchased, sold, or redeemed any listed securities during the reporting period[141]. - The annual report for the year ending December 31, 2023, will be published in due course, containing all required information[147]. - The company has not conducted any significant activities since December 31, 2023, up to the date of this announcement[152]. - The company is committed to transparency and accountability in its business strategies and policies[138]. - There were no dividends declared or proposed for ordinary shareholders during the reporting period[91].

體內外表面的組織及產生於胚胎發生過程中內胚層、中 72 | --- | --- | --- | |----------------------|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | 「細胞株」 | 指 | 由單一細胞發展而來的細胞培養，故此包括具有統一基 因組成的細胞 | | 「西妥昔單抗」 | 指 | 獲 FDA 批准用於在若干條件下治療 KRAS 野 生 型、 EGFR 表達轉移性結直腸癌的 EGFR 拮抗物 | | 「 cGMP 」 | 指 | 現行的良好生產規範 | | 「中國倉鼠卵巢細胞」 | 指 | 中國倉鼠卵巢細胞，細胞株由其衍生而來，倉鼠卵巢細 | ...

Product Development and Pipeline - The company focuses on the development and commercialization of innovative biopharmaceuticals for cancer and autoimmune diseases, with a pipeline that includes 9 monoclonal antibody drugs and 1 strong antibody drug[1]. - CMAB007, a recombinant humanized anti-IgE monoclonal antibody, has shown efficacy in 4 clinical trials involving 824 subjects, indicating its potential to improve asthma conditions with lower doses of inhaled corticosteroids[4]. - CMAB009 is expected to be approved for market in Q2 2024, becoming the first domestically produced anti-EGFR monoclonal antibody for mCRC treatment in China, potentially benefiting hundreds of thousands of patients[9]. - CMAB007 is anticipated to expand its indications to include chronic spontaneous urticaria, seasonal allergic rhinitis, and food allergies[4]. - The company is exploring the combination use of CMAB009 with various small molecule drugs for broader cancer treatment applications[9]. - CMAB807 has completed Phase III clinical trials for osteoporosis and is in the NDA submission stage[29]. - CMAB819 is currently undergoing Phase I clinical trials and is anticipated to receive approval by Q4 2027 for the treatment of metastatic non-small cell lung cancer, hepatocellular carcinoma, and head and neck squamous cell carcinoma[50]. - CMAB022, a biosimilar candidate for Stelara®, is in the process of trial development and is expected to receive approval by Q3 2027[51]. - CMAB023, a monoclonal antibody targeting TSLP, has completed cell line construction and is projected to receive approval by Q2 2028[52]. - CMAB807X is expected to receive approval from the National Medical Products Administration (NMPA) in Q2 2028 for the treatment of tumor bone metastasis[68]. - CMAB017, an innovative strong antibody drug, is anticipated to receive NMPA approval for late-stage solid tumors in Q2 2029, showing improved efficacy and safety compared to existing products[69]. - CMAB015, a biosimilar to secukinumab, is undergoing Phase I clinical trials and is expected to receive NMPA approval for psoriasis and ankylosing spondylitis in Q4 2025[70]. - CMAB018, a biosimilar candidate for mepolizumab, is in preclinical research and is expected to receive NMPA approval in Q4 2027 for severe asthma and eosinophilic granulomatosis with polyangiitis[71]. Financial Performance - The company reported a net loss of RMB 0.02 per share for the six months ending June 30, 2023, compared to a loss of RMB 0.03 per share for the same period in 2022[16]. - Revenue for the first half of 2023 was RMB 44,020,000, a 52.6% increase from RMB 28,847,000 in the same period last year[24]. - The company reported a pre-tax loss of RMB 99,999,000, a 14.4% improvement from RMB 116,809,000 in the previous year[24]. - The company reported a net loss of RMB 99,999,000 for the six months ended June 30, 2023, which is a 14.4% improvement from a net loss of RMB 116,809,000 in the same period last year[86]. - The gross profit for the same period was RMB 37,822,000, reflecting a significant increase of 112.6% from RMB 17,793,000 in the previous year[86]. - The revenue from drug sales reached RMB 36,071,000, a substantial increase from RMB 4,203,000 in the previous year[87]. - The company’s total equity as of June 30, 2023, was RMB 306,623,000, down from RMB 491,128,000 at the end of 2022, reflecting a decrease of 37.5%[154]. - The company reported a decrease in total costs to RMB 59.5 million for the six months ended June 30, 2023, down from RMB 77.99 million for the same period in 2022[92]. - The company experienced a net cash outflow from operating activities of RMB 33,534,000 for the six months ended June 30, 2023, compared to RMB 11,045,000 for the same period in 2022, indicating a worsening cash flow situation[162]. - The company’s investment activities generated a net cash inflow of RMB 8,016,000, contrasting with a cash outflow of RMB 63,067,000 in the previous period[155]. Research and Development - The company aims to leverage its extensive R&D experience to develop multiple therapeutic products, enhancing its market presence[1]. - The focus of research and development is on monoclonal antibody drugs targeting cancers and autoimmune diseases, which have substantial unmet clinical needs in China[32]. - The company has established a strong R&D capability and advanced manufacturing techniques, enabling it to provide high-quality and cost-effective biopharmaceutical products to emerging markets[74]. - The R&D team consists of professionals with extensive industry experience and solid academic backgrounds in immunology, molecular biology, oncology, and monoclonal antibody development[74]. - The company plans to enhance its R&D capabilities by investing in innovative technologies to develop more effective and less toxic drugs[81]. - The company is focusing on recruiting and retaining high-quality R&D talent through collaborations with top universities and providing advanced training programs[82]. Market Strategy and Expansion - The company is focusing on building its own sales team while leveraging partnerships to enhance market share and sales growth[31]. - The company aims to seize significant market opportunities in China, particularly due to recent medical regulatory reforms and new healthcare measures[32]. - The company is actively expanding its global market presence and accelerating the registration and launch of its drugs in international markets[39]. - The company has initiated exclusive commercialization agreements for CMAB009 with Jiangsu Xiansheng Zaiming Pharmaceutical Co., Ltd., enhancing its market presence in China[37]. - The company plans to negotiate the extension of a bank loan amounting to RMB 50 million based on market practices to alleviate liquidity pressure[189]. - The company aims to establish partnerships with domestic and international pharmaceutical companies to expand its market reach beyond China[83]. Quality Assurance and Compliance - The company has established a quality assurance department to ensure compliance with high industry standards and regulations throughout the product lifecycle[12]. - The company is committed to maintaining effective quality management systems for raw materials, equipment, and finished products to ensure service quality and reputation[12]. - The company has completed procurement listings in four provincial and GPO platforms for CMAB007, with the first commercial shipment already executed[36]. - The distribution network is established in compliance with national regulations, ensuring effective coverage and control over distribution costs and accounts receivable[55].

Product Development and Pipeline - The company has developed a total of 10 monoclonal antibody drugs, including 9 new monoclonal antibodies and 1 strong antibody, focusing on allergic diseases, autoimmune diseases, and tumors[8] - CMAB008, the first monoclonal antibody drug produced by a Chinese company, has been approved for commercialization in the Chinese market, addressing significant unmet market needs for conditions such as Crohn's disease and psoriasis[8] - The company successfully completed the clinical trials for CMAB007, the first domestically produced anti-IgE monoclonal antibody for allergic diseases, which is expected to be launched soon[8] - CMAB009, a new drug for treating metastatic colorectal cancer, has submitted its NDA to the National Medical Products Administration and is expected to be approved for market launch in Q2 2024, potentially benefiting over 1 million patients[15] - The company is focusing on expanding its product pipeline in allergic diseases, autoimmune diseases, and tumors, leveraging its strong R&D capabilities to enhance innovation and competitiveness[8] - The company has developed next-generation allergy treatments, including CMAB023, which shows improved efficacy[8] - The company’s core products are positioned to meet the substantial clinical demand in China for monoclonal antibody drugs targeting cancer and autoimmune diseases[17] - CMAB007 is expected to be the first monoclonal antibody for asthma developed and launched by a domestic company in China upon approval[23] - CMAB009 is the first domestically developed anti-EGFR monoclonal antibody for colorectal cancer treatment, with NDA application submitted to the National Medical Products Administration[24] - CMAB015 has been initiated in Phase I clinical trials, demonstrating significant efficacy in treating psoriasis, becoming one of the fastest-growing biologics in China[30] - The company has developed a broad-spectrum anti-allergy monoclonal antibody targeting TSLP, indicating strong market potential[30] - CMAB017 has been approved for clinical trials to treat advanced solid tumors, showing good efficacy and safety compared to existing EGFR antibody drugs[30] - CMAB807 is currently undergoing Phase III clinical trials for osteoporosis, with all cases completed and entering NDA submission preparation[29] - CMAB018 (Mepolizumab) and CMAB022 (Ustekinumab) are both expected to submit clinical trial applications by Q4 2024, indicating ongoing development in the pipeline[34] - CMAB819 (Nivolumab) is currently undergoing Phase I clinical trials, with anticipated market approval by Q4 2027, aimed at treating metastatic non-small cell lung cancer, liver cancer, and head and neck squamous cell carcinoma[44] - CMAB807X, a formulation for treating tumor bone metastasis, is expected to enter Phase III clinical trials in Q4 2023, with approval projected for Q4 2027[102] Market Strategy and Expansion - The Chinese biopharmaceutical market is rapidly growing, with significant opportunities arising from recent medical regulatory reforms, particularly in monoclonal antibody drugs[10] - The company aims to collaborate with leading domestic pharmaceutical companies to enhance product sales and address market gaps in high unmet needs areas[10] - The company has established exclusive promotion agreements for CMAB008, anticipating substantial revenue from ongoing sales in the future[22] - The company has initiated registration and expansion efforts in over 30 countries and regions, with expectations to soon pass GMP audits and obtain market approvals[65] - The company plans to collaborate closely with overseas partners to register and develop new products in various countries and regions, enhancing global sales growth[81] - The company is actively participating in China's healthcare reform to capture unmet market demand through advanced technology and cost-effective solutions[90] - The company is actively seeking strategic partnerships and participating in industry forums to enhance collaboration and resource sharing[119] Financial Performance - Revenue for the year ended December 31 was RMB 55,918,000, a decrease of 32.5% compared to RMB 82,882,000 in the previous year[78] - The company reported a net loss of RMB 210,819,000 for the year, a reduction of 27.7% from the previous year's loss of RMB 291,744,000[78] - Research and development expenses decreased by 43.9% to RMB 147,906,000 from RMB 263,572,000 year-over-year[78] - The company's drug sales revenue reached RMB 21,544 thousand in 2022, a significant increase from RMB 1,636 thousand in 2021[176] - The exclusive promotion rights income in mainland China amounted to RMB 10,613 thousand in 2022, with no income reported in 2021[176] - CDMO contract revenue was RMB 23,761 thousand in 2022, with no prior year income reported[176] Operational Efficiency and R&D - The company is focusing on the development of monoclonal antibodies, with core R&D team members having over 19 years of experience in this field[68] - The innovative and industrialization team continues to provide stable and efficient R&D pipelines and production capacity guarantees[63] - The company has a strong foundation in equipment, technology, and quality in the field of antibody drug preparation, providing a competitive advantage in future medical insurance negotiations[69] - The company is actively expanding its CDMO business without affecting its own product development, achieving satisfactory performance[62] - The company completed the construction of three new production lines in Taizhou in 2021, increasing the total scale of its cell reactors to 18,000 liters, with plans to exceed 40,000 liters by 2023[69] Employee and Workplace Management - The company employed a total of 417 full-time employees during the reporting period, with 126 new hires[124] - The percentage of female employees in management positions is 20%, with 47% of senior management being female[126] - Employee turnover rates were reported at 26.26% for male employees and 32.42% for female employees, indicating a need for improved employee retention strategies[157] - Approximately 800 employees completed training on drug safety reporting and adverse reaction documentation[106] - The company reported zero employee work-related accidents and fatalities in 2022[138] Environmental and Safety Initiatives - The company is transitioning to environmentally friendly disinfectants, aiming to implement these changes by April 2023[118] - The company has established a monitoring mechanism for energy usage, conducting monthly energy consumption analyses to optimize facility operations[151] - The company is actively exploring energy-efficient production facilities to reduce carbon emissions[180] - Implementation of a cold source management system for chillers has improved energy efficiency by automating operations based on key parameters[185] - Water resource management measures have been adopted to enhance water utilization efficiency, including the conversion of cooling water to a closed-loop system[187] - The company adheres to waste management principles of harmlessness, reduction, and resource utilization, ensuring proper disposal of all waste[190] - The company has updated its hazardous chemical management system to comply with national regulations, ensuring safe production and environmental protection[191] - The installation of a sludge pool has effectively reduced the generation of hazardous waste by converting it into general solid waste[198] - Employee training on waste management policies and practices has been conducted to enhance waste management capabilities[199] Quality Assurance and Compliance - The company has established a quality assurance department to ensure product and service quality meets high industry standards[143] - The company conducted on-site audits of 9 suppliers during the reporting period to ensure compliance with quality standards[111] - A simulated recall exercise for injectable products achieved a 100% recall rate, demonstrating the effectiveness of the product recall system[105] - The company participated in four National Pharmacopoeia Committee meetings in 2022, contributing to the establishment of national standards[120] - The company engaged in technical cooperation with several renowned research centers and hospitals to promote innovative drug development[121]

Financial Performance - For the six months ended June 30, 2022, the company reported revenue of RMB 28,847,000, a decrease of 64.5% compared to RMB 81,246,000 in the same period of 2021[29]. - Gross profit for the same period was RMB 17,793,000, down 72.4% from RMB 64,477,000 in 2021[29]. - The company reported a loss before tax of RMB 116,809,000, which is a 19.5% improvement compared to a loss of RMB 145,161,000 in the prior year[29]. - The net loss for the period was RMB 116.8 million, reflecting a 19.5% reduction from RMB 145.2 million in the same period last year[100]. - Revenue from sales for the period was RMB 28,847 thousand, a decrease of 64.5% from RMB 81,246 thousand in the previous year[196]. - Gross profit for the period was RMB 17,793 thousand, down from RMB 64,477 thousand in the prior year, indicating a significant decline in profitability[196]. - Research and development expenses were RMB 77,990 thousand, reduced from RMB 163,455 thousand in the previous year, reflecting a 52.3% decrease[196]. - Basic loss per share attributable to ordinary equity holders was RMB 0.03, compared to RMB 0.04 in the previous year, showing a slight improvement[198]. Research and Development - Research and development expenses decreased by 52.3% to RMB 77,990,000 from RMB 163,455,000 year-over-year[29]. - The company has a pipeline that includes 10 monoclonal antibody drugs and 1 strong antibody drug, with 3 core products approved for various treatments[32]. - CMAB008 has been approved for six indications, with a patient population exceeding 10 million in China, indicating significant unmet market demand[33]. - CMAB007 (Omalizumab) is expected to be approved for market launch in Q1 2023, aiming to be the first domestically produced Omalizumab in China[37]. - CMAB009 (Cetuximab) is undergoing Phase III clinical trials for colorectal cancer, with NDA data preparation expected to be completed soon[38]. - CMAB017 has been approved for clinical trials targeting advanced solid tumors, showing promising efficacy and safety compared to existing EGFR antibody drugs[39]. - The company has a robust pipeline with multiple candidates in various stages of development, including CMAB007 and CMAB009, targeting significant therapeutic areas[49]. - The company is committed to advancing clinical research and commercialization of its candidate drugs, particularly CMAB008, CMAB007, CMAB009, CMAB807, CMAB015, and CMAB022[92]. Market Expansion and Strategy - The company is actively pursuing global market expansion, having initiated registration and expansion efforts in over 30 countries and regions[33]. - The company plans to leverage its strong internal capabilities and partnerships to enhance commercialization of its drug pipeline[41]. - The company aims to leverage the opportunities presented by China's healthcare reforms, targeting specific departments such as gastroenterology, respiratory diseases, and oncology for product promotion[89]. - The company plans to enhance its sales capabilities by collaborating with experienced sales service providers and distributors, emphasizing long-term prescription drug sales experience[84]. - The company is focusing on establishing a distribution network for CMAB008 in compliance with national drug sales regulations, ensuring effective coverage and controlling distribution costs[84]. Production Capacity and Facilities - The company has expanded its production capacity to 18,000 liters and is set to exceed 40,000 liters by the end of 2022 with new GMP production lines[42]. - The existing production facility in Taizhou spans 30,000 square meters and includes four 1,500-liter antibody bioreactor systems, capable of producing 4 million vials annually[77]. - A new production facility is under construction on a 100,746 square meter site, with large-scale bioreactor production lines expected to exceed 40,000 liters by the end of 2022[80]. - The company utilized approximately RMB 960.1 million of the net proceeds from the global offering, with RMB 180.9 million allocated for core product R&D and RMB 489.9 million for production expansion in Taizhou, China[149]. Corporate Governance and Management - The company is committed to maintaining high levels of corporate governance to protect shareholder interests and enhance corporate value[178]. - The board confirms compliance with all applicable corporate governance code provisions as of June 30, 2022[178]. - The company has adopted the standard code for securities transactions by directors as its guideline for trading its securities[179]. - All directors have confirmed compliance with the applicable standards of the code during the reporting period[179]. - The audit committee confirmed the effectiveness of the company's risk management and internal control systems[183]. Employee and Talent Management - The company has 389 employees as of June 30, 2022, with 247 in R&D and 71 in business units[156]. - Employee costs increased from RMB 19,414 thousand in 2021 to RMB 21,698 thousand in 2022, representing a growth of 11.8%[119]. - The company aims to recruit and retain high-quality R&D talent through partnerships with top universities and systematic training programs[94]. - The company has maintained good employee relations and has not faced significant difficulties in recruitment during the reporting period[159]. Financial Position and Liabilities - Non-current assets increased by 9.5% to RMB 713,775,000 from RMB 652,132,000 as of December 31, 2021[29]. - Current assets decreased by 9.5% to RMB 224,229,000 from RMB 247,770,000 as of December 31, 2021[29]. - The company’s net asset value decreased by 18.4% to RMB 491,128,000 from RMB 601,981,000 as of December 31, 2021[29]. - The company's capital structure shifted to 47.6% debt and 52.4% equity as of June 30, 2022, compared to 33.1% debt and 66.9% equity on December 31, 2021[138]. - The current ratio decreased from 1.1 on December 31, 2021, to 1.0 on June 30, 2022, indicating a slight decline in liquidity[144]. - The quick ratio also fell from 0.8 on December 31, 2021, to 0.6 on June 30, 2022, reflecting a decrease in immediate liquidity[144]. - The total liabilities included RMB 45.6 million in lease liabilities and RMB 81.1 million in interest-bearing bank and other borrowings as of June 30, 2022[134].