康宁杰瑞制药(09966) - 2025 - 中期业绩

ALPHAMAB ONCOLOGY Interim Results Announcement for the Six Months Ended June 30, 2025 Overview of Announcement ALPHAMAB Oncology is pleased to announce its unaudited condensed consolidated interim results for the six months ended June 30, 2025, with comparative data for the same period in 2024 Financial Highlights This section provides a concise overview of the company's interim financial performance and position Summary of Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, the company achieved significant revenue growth, turned from loss to profit, substantially increased gross profit and total comprehensive income, despite higher R&D expenses | Indicator | 2025 (thousand RMB) | 2024 (thousand RMB) | | :--- | :--- | :--- | | Revenue | 319,438 | 173,561 | | Cost of Sales | (31,257) | (30,807) | | Gross Profit | 288,181 | 142,754 | | Other Income | 27,211 | 39,786 | | Other Gains and Losses | (2,334) | 7,293 | | Research and Development Expenses | (253,163) | (194,531) | | Administrative Expenses | (34,375) | (34,635) | | Finance Costs | (3,945) | (5,563) | | Profit (Loss) Before Tax | 21,575 | (44,896) | | Income Tax Expense | – | – | | Profit (Loss) for the Period | 21,575 | (44,896) | | Total Comprehensive Income (Expense) for the Period | 21,876 | (44,614) | Summary of Condensed Consolidated Statement of Financial Position As of June 30, 2025, the company's current assets and net assets increased, alongside a rise in current liabilities, maintaining a stable overall asset structure | Indicator | As of June 30, 2025 (thousand RMB) | As of December 31, 2024 (thousand RMB) | | :--- | :--- | :--- | | Non-current Assets | 523,765 | 530,406 | | Current Assets | 1,835,164 | 1,711,349 | | Non-current Liabilities | 135,249 | 155,827 | | Current Liabilities | 368,699 | 254,044 | | Net Assets | 1,854,981 | 1,831,884 | Business Overview This section summarizes the company's business developments, profile, product pipeline, and technology platforms Key Business Progress During the Reporting Period During the reporting period, the company achieved significant clinical research and IND application progress across multiple drug pipelines, including first patient dosing, results publication, and breakthrough therapy designations - Phase II clinical study results of KN026 combined with docetaxel for HER2+ recurrent or metastatic breast cancer have been fully published in 'Cancer Communications'[6] - Phase I/II clinical trial of JSKN033 for advanced metastatic malignancies completed first patient dosing, with dose escalation completed and cohort expansion ongoing; concurrently, a Phase II clinical trial for JSKN033 in HER2-mutated/expressing non-small cell lung cancer has been initiated[6] - JSKN003 received CDE approval to initiate a Phase III clinical trial for HER2+ breast cancer patients, with first patient dosing completed; simultaneously, a Phase III clinical trial for JSKN003 in platinum-resistant recurrent ovarian cancer also completed first patient dosing[6] - Full results of the Phase II clinical study of KN046 combined with lenvatinib for unresectable advanced or metastatic hepatocellular carcinoma have been published in 'Nature Communications'[7] - IND applications for JSKN016 combined with chemotherapy/immunotherapy/TKI for multiple cohorts in first-line and later-line NSCLC treatment received CDE approval, with dose confirmation completed; Phase II clinical trials for JSKN016 monotherapy in multiple NSCLC cohorts are ongoing[7] - JSKN003 received Breakthrough Therapy Designation from CDE for the treatment of platinum-resistant ovarian cancer, regardless of HER2 expression level[7] - Phase II/III clinical trial of KN026 combined with chemotherapy for second-line and above HER2+ gastric cancer completed its first PFS interim analysis, meeting the primary endpoint and showing an OS benefit trend[7] - Three Phase II clinical study results for KN035 (Envafolimab) as monotherapy or in combination were presented at the 2025 ASCO Annual Meeting, with an additional eight clinical study results published online[9] - JSKN003 received Orphan Drug Designation from the US FDA for gastric cancer/gastroesophageal junction cancer, and FDA approval to conduct a Phase II clinical study in the US for platinum-resistant ovarian cancer, regardless of HER2 expression level[9] - IND application for JSKN022 in Phase I clinical trials for advanced solid tumors has been accepted by CDE[9] Company Profile and Mission ALPHAMAB Oncology is a leading Chinese biopharmaceutical company focused on ADC, bispecific antibodies, and multifunctional protein engineering, committed to providing innovative biologics to global patients - The company is a leading biopharmaceutical company in China, possessing comprehensive proprietary technology platforms for ADC, bispecific antibodies, and multifunctional protein engineering[10] - Its mission is to provide world-class innovative therapeutic biologics to global patients by leveraging its unique drug discovery and development capabilities[10] Product Pipeline The company boasts a highly differentiated in-house pipeline covering ADCs, oncology monoclonal antibodies, and bispecific antibodies, with multiple products in Phase III or pivotal clinical trials, and KN035 already approved for market - The product pipeline comprises ADCs, oncology monoclonal antibodies, and bispecific antibodies at various R&D stages, including one product approved by the NMPA and multiple products in Phase III or pivotal clinical trials[11] Overview of Key Product Pipeline | Candidate Drug | Indication | Combination Therapy | IND | Phase I | Phase II | Pivotal Clinical (Phase II/III) | NDA | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | KN035 (Subcutaneous PD-L1) | ≥2L MSI-H/dMMR Advanced Solid Tumors | Monotherapy | | | | | ✅ | | KN026 (HER2/HER2 Bispecific Antibody) | 1L HER2+ BC HER2+ BC Neoadjuvant 1L HER2+ GC/GEJ | +Albumin Docetaxel +Albumin Docetaxel Planned | | | | ✅ ✅ Ongoing | | | JSKN003 (HER2 Bispecific ADC) | Later-line HER2-low BC Platinum-resistant Ovarian Cancer ≥2L HER2+ BC HER2-expressing Solid Tumors Platinum-resistant Ovarian Cancer 1 1L HER2+ GC/GEJ HER2-negative BC | Monotherapy Monotherapy Monotherapy Monotherapy Monotherapy +IO/Chemotherapy Monotherapy | | | | ✅ ✅ ✅ Ongoing Ongoing Ongoing | | | JSKN016 (HER3/TROP2 Bispecific ADC) | NSCLC NSCLC HER2-negative BC Other Advanced Solid Tumors | Monotherapy Combination Combination Monotherapy | | | Ongoing Ongoing Ongoing Ongoing | | | JSKN033 (Subcutaneous formulation of JSKN003 and KN035) | Advanced Solid Tumors HER2-mutated/expressing NSCLC | Monotherapy Monotherapy | | Ongoing Ongoing | | | | | JSKN022 (PD-L1/αvβ6 Bispecific ADC) | Advanced Solid Tumors 2 | Monotherapy | Ongoing | | | | | | KN046 (PD-L1/CTLA-4 Bispecific Antibody) | 1L Squamous NSCLC | +Chemotherapy | | | | Ongoing | | Core Technology Platforms and Manufacturing Capabilities The company possesses structure-guided protein engineering capabilities and proprietary platforms, including sdAb and CRIB, and is expanding its manufacturing facilities to exceed 40,000L total capacity, compliant with international standards - Possesses structure-guided protein engineering capabilities, enabling the development of various protein building block formats[12] - Proprietary platforms developed in-house include the sdAb platform, CRIB platform, glycan-specific conjugation platform, linker-payload platform, subcutaneous high-concentration formulation platform, and glycan-specific dual-payload conjugation platform[12] - Leading manufacturing capabilities will be further enhanced through the design and construction of new facilities compliant with NMPA, EMA, and FDA current Good Manufacturing Practice standards, with an expected total capacity exceeding 40,000L[12] Management Discussion and Analysis This section analyzes the company's financial performance, balance sheet, liquidity, and funding sources Financial Performance Overview For the six months ended June 30, 2025, the company's total revenue grew to