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康宁杰瑞制药(09966) - 2025 - 中期业绩
2025-08-28 12:23
[ALPHAMAB ONCOLOGY Interim Results Announcement for the Six Months Ended June 30, 2025](index=1&type=section&id=ALPHAMAB%20Oncology%20Interim%20Results%20Announcement) [Overview of Announcement](index=1&type=section&id=Overview%20of%20Announcement) 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](index=1&type=section&id=Financial%20Highlights) 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](index=1&type=section&id=Summary%20of%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) 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](index=2&type=section&id=Summary%20of%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) 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](index=2&type=section&id=Business%20Overview) This section summarizes the company's business developments, profile, product pipeline, and technology platforms [Key Business Progress During the Reporting Period](index=2&type=section&id=Key%20Business%20Progress%20During%20the%20Reporting%20Period) 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](index=6&type=chunk) - 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](index=6&type=chunk) - 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](index=6&type=chunk) - 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](index=7&type=chunk) - 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](index=7&type=chunk) - JSKN003 received Breakthrough Therapy Designation from CDE for the treatment of platinum-resistant ovarian cancer, regardless of HER2 expression level[7](index=7&type=chunk) - 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](index=7&type=chunk) - 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](index=9&type=chunk) - 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](index=9&type=chunk) - IND application for JSKN022 in Phase I clinical trials for advanced solid tumors has been accepted by CDE[9](index=9&type=chunk) [Company Profile and Mission](index=5&type=section&id=Company%20Profile%20and%20Mission) 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](index=10&type=chunk) - Its mission is to provide world-class innovative therapeutic biologics to global patients by leveraging its unique drug discovery and development capabilities[10](index=10&type=chunk) [Product Pipeline](index=5&type=section&id=Product%20Pipeline) 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](index=11&type=chunk) 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](index=6&type=section&id=Core%20Technology%20Platforms%20and%20Manufacturing%20Capabilities) 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](index=12&type=chunk) - 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](index=12&type=chunk) - 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](index=12&type=chunk) [Management Discussion and Analysis](index=7&type=section&id=Management%20Discussion%20and%20Analysis) This section analyzes the company's financial performance, balance sheet, liquidity, and funding sources [Financial Performance Overview](index=7&type=section&id=Financial%20Performance%20Overview) For the six months ended June 30, 2025, the company's total revenue grew to
港股收盘 | 恒指收跌1.18% 黄金股逆市走高 医药、内房股等多数承压
Zhi Tong Cai Jing· 2025-08-26 09:08
Market Overview - The Hong Kong stock market failed to maintain its strong performance from the previous day, with all three major indices experiencing a collective adjustment. The Hang Seng Index fell by 1.18% or 304.99 points, closing at 25,524.92 points, with a total trading volume of HKD 31.78 billion. The Hang Seng China Enterprises Index decreased by 1.07% to 9,148.66 points, while the Hang Seng Tech Index dropped by 0.74% to 5,782.24 points [1] Blue-Chip Stocks Performance - CSPC Pharmaceutical Group (01093) led the decline among blue-chip stocks, falling by 4.33% to HKD 10.38, with a trading volume of HKD 1.797 billion, contributing a loss of 6.04 points to the Hang Seng Index. Bank of America Securities reported a 14.3% year-on-year decline in total revenue for CSPC in Q2, with attributable net profit down 24% to RMB 1.1 billion. The firm revised its revenue forecasts for 2025 to 2027 down by 25%, 2%, and 11% respectively [2] Sector Highlights - Large technology stocks mostly declined, with Alibaba down 2.57% and Tencent down 0.81%. Gold stocks surged, with China Gold International rising over 10%. Apple is expected to initiate a three-year innovation cycle, boosting related stocks like Lens Technology, which rose over 5%. Gaming stocks and some new consumption concepts performed well, with Melco International Development up over 9% [3][5] Federal Reserve Insights - Federal Reserve Chairman Jerome Powell indicated rising downside risks in the U.S. labor market, suggesting a potential policy adjustment could be appropriate. This statement is seen as a strong signal for a possible interest rate cut as early as September. The market reacted positively, particularly for precious metals, with expectations for further increases in gold prices [4] Gaming Sector Performance - The gaming sector continued its upward trend, with Melco International Development rising 9.27% to HKD 5.54. According to JPMorgan, Macau's gaming revenue for the first 24 days of August reached MOP 17.65 billion, with a daily average of MOP 735 million, reflecting a 9% increase from the previous week [6] Pharmaceutical Sector Challenges - The pharmaceutical sector faced pressure, with several stocks declining. Notably, CStone Pharmaceuticals (09966) fell 6.74% to HKD 10.24. U.S. President Trump's announcement to drastically reduce drug prices could create significant challenges for the global pharmaceutical industry, presenting both opportunities and risks for Chinese biotech stocks [6] Notable Stock Movements - Double Ended Co. (06960) debuted with a 31.29% increase, closing at HKD 19.05. The company focuses on energy storage solutions in the data and communication sectors, with a projected market share of 11.1% by 2024 [7] - Kingsoft Holdings (03918) reached a new high, rising 17.94% to HKD 5.72, reporting a 16.76% year-on-year revenue increase to USD 342 million [8] - Angelalign Technology (06699) saw a 10.28% increase to HKD 75.1, with a 33.1% year-on-year revenue growth reported [9] - Meitu Inc. (01357) rose 7.9% to HKD 11.47 after being included in the MSCI China Index, with Morgan Stanley expressing confidence in its long-term growth potential [10] - Xintai Medical (02291) experienced a significant drop of 12.75% to HKD 23.96 following a major shareholder's sale of shares [11]
康宁杰瑞制药-B涨幅扩大逾15% 下周四将发中期业绩 预计扭亏为盈至不少于2000万元
Zhi Tong Cai Jing· 2025-08-22 07:59
Core Viewpoint - 康宁杰瑞制药-B's stock price increased by 14.03% to HKD 10.81, with a trading volume of HKD 73.86 million, following the announcement of a board meeting to approve mid-term results [1] Financial Performance - The company expects to report a profit of no less than RMB 20 million for the first half of the year, compared to a loss of approximately RMB 44.90 million in the same period last year [1] - The turnaround from loss to profit is attributed to milestone revenues from three licensing agreements and sales revenue from commercialized products [1] Product Development - The clinical trial application for JSKN022, a dual-specific antibody-drug conjugate targeting PD-L1 and integrin αvβ6, has been officially accepted by the National Medical Products Administration of China [1] - The company plans to initiate the first human clinical study for JSKN022 aimed at treating advanced malignant solid tumors [1] - Currently, there are no marketed antibody-drug conjugates targeting integrin αvβ6 or PD-L1 globally, with related investigational drugs still in clinical research stages [1]
港股异动 | 康宁杰瑞制药-B(09966)涨幅扩大逾15% 下周四将发中期业绩 预计扭亏为盈至不少于2000万元
智通财经网· 2025-08-22 07:57
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock price increase of 14.03%, reaching HKD 10.81, with a trading volume of HKD 73.86 million, ahead of its upcoming board meeting to approve mid-term results [1] Financial Performance - The company expects to report a profit of no less than RMB 20 million for the first half of the year, a turnaround from a loss of approximately RMB 44.9 million in the same period last year [1] Business Developments - The turnaround to profitability is attributed to milestone revenues from three authorized collaborations and sales revenue from commercialized products [1] - The company’s self-developed PD-L1/integrin αvβ6 bispecific antibody-drug conjugate (ADC) JSKN022 has had its new drug clinical trial application formally accepted by the Center for Drug Evaluation of the National Medical Products Administration of China [1] - The company plans to initiate the first human clinical study of JSKN022 for the treatment of advanced malignant solid tumors, with no currently marketed ADCs targeting integrin αvβ6 or PD-L1 globally, and related investigational drugs are still in clinical research stages [1]
康宁杰瑞制药(09966) - 补充公告 关连交易 - 与苏州康寧杰瑞的技术开发合作
2025-08-18 10:43
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 ALPHAMAB ONCOLOGY 本公司謹此對該公告補充以下有關支付條款的資料。 支付條款 根據技術開發合同,江蘇康寧傑瑞同意於簽署合同後向蘇州康寧傑瑞支付人民幣 3,072,000元的首期付款,並啟動項目。餘下人民幣7,168,000元將以四筆里程碑付 款的形式支付,各款項與項目的具體交付成果及階段掛鈎。各里程碑付款的金額 及時間表乃由各方經公平磋商後釐定,確保符合相應交付成果及項目進度的工作 量、複雜程度及重要程度,包括完成工藝開發與確認、毒理批次的研製及放行檢 測及交付穩定性研究數據。 倘蘇州康寧傑瑞未能於截至2028年7月31日止三年內交付技術成果,江蘇康寧傑 瑞毋須支付額外款項。 1 除上文所披露者外,該公告所載的所有資料維持不變。本公告為該公告的補充, 應與該公告一併閱讀。 康寧傑瑞生物製藥 (於開曼群島註冊成立的有限公司) (股份代號:9966) 補充公告 關連交易-與蘇州康寧傑瑞的技術 ...
康宁杰瑞制药-B再涨超7% 本月底将发中期业绩 预计上半年利润不少于2000万元
Zhi Tong Cai Jing· 2025-08-18 06:59
Core Viewpoint - 康宁杰瑞制药-B (09966) has experienced a significant stock price increase, reflecting positive market sentiment ahead of its upcoming board meeting to approve mid-term results, which are expected to show a profit turnaround [1] Financial Performance - The company anticipates a profit of no less than RMB 20 million for the first half of the year, a notable improvement from a loss of approximately RMB 44.9 million in the same period last year [1] - The turnaround to profitability is attributed to milestone revenues from three authorized collaborations and sales revenue from commercialized products [1] Product Development - 康宁杰瑞制药 has announced that its self-developed PD-L1/integrin αvβ6 bispecific antibody-drug conjugate (ADC) JSKN022 has received formal acceptance for clinical trial application from the China National Medical Products Administration [1] - The company plans to initiate the first human clinical study of JSKN022 for the treatment of advanced malignant solid tumors [1] - Currently, there are no marketed ADCs targeting integrin αvβ6 or PD-L1 globally, and related investigational drugs are still in clinical research stages [1]
港股异动 | 康宁杰瑞制药-B(09966)再涨超7% 本月底将发中期业绩 预计上半年利润不少于2000万元
智通财经网· 2025-08-18 06:52
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock price increase, rising over 7% and currently trading at 9.59 HKD, with a trading volume of 32.19 million HKD. The company is set to hold a board meeting on August 28 to approve its mid-term performance, with expectations of a profit of no less than 20 million RMB for the first half of the year, compared to a loss of approximately 44.90 million RMB in the same period last year. The turnaround is attributed to milestone revenues from three authorized collaborations and sales from commercialized products. Additionally, the company has received acceptance for its clinical trial application for the dual-specific antibody-drug conjugate JSKN022, aimed at treating advanced malignant solid tumors, marking a significant development in the market as no similar targeted ADCs are currently available globally [1][1][1]. Financial Performance - The company anticipates a profit of at least 20 million RMB for the first half of the year, a notable recovery from a loss of around 44.90 million RMB in the previous year [1][1][1]. - The financial turnaround is primarily driven by milestone revenues from three authorized collaborations and sales from commercialized products [1][1][1]. Product Development - Corning Jereh Pharmaceutical has announced that its self-developed dual-specific antibody-drug conjugate JSKN022 has had its clinical trial application formally accepted by the National Medical Products Administration of China [1][1][1]. - The planned clinical study for JSKN022 will focus on treating advanced malignant solid tumors, with no existing targeted ADCs for integrin αvβ6 or PD-L1 currently available on the market [1][1][1].
【盈喜】康宁杰瑞制药-B(09966.HK)料中期转亏为盈 利润不少于2000万元
Jin Rong Jie· 2025-08-14 04:00
Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) expects to report a profit of no less than RMB 20 million for the six months ending June 30, 2025, compared to a loss of approximately RMB 44.9 million in the same period of 2024, indicating a turnaround from loss to profit driven by milestone revenues from three licensing collaborations and sales revenue from commercialized products [1] Financial Performance - The company anticipates a profit of at least RMB 20 million for the upcoming reporting period [1] - In contrast, the previous year’s corresponding period showed a loss of around RMB 44.9 million [1] Revenue Drivers - The turnaround to profitability is attributed to milestone income from three licensing agreements [1] - Additionally, revenue from the sales of commercialized products contributed to the positive financial outlook [1]
港股异动 康宁杰瑞制药-B(09966)盈喜后涨超3% 预计中期利润不少于2000万元
Jin Rong Jie· 2025-08-14 03:13
Core Viewpoint - 康宁杰瑞制药-B (09966)预计在截至2025年6月30日的六个月内实现利润不少于人民币2000万元,相较于2024年同期的亏损约人民币4490万元,显示出公司在财务上的显著改善 [1] Financial Performance - 康宁杰瑞制药-B在最新公告中提到,报告期内公司实现了转亏为盈,主要得益于三项授权合作的里程碑收入和商业化产品的销售收入 [1] Technology and Pipeline - 广发证券指出,康宁杰瑞制药-B在抗体药物偶联物(ADC)、双特异性抗体和多功能蛋白质工程方面拥有完善的专有技术平台,内部管线高度差异化,涵盖处于不同研发阶段的抗肿瘤药物 [1] - 公司差异化的生物大分子平台以及已展现初步临床疗效的ADC药物的发展潜力受到看好 [1]
康宁杰瑞制药-B盈喜后涨超3% 预计中期利润不少于2000万元
Zhi Tong Cai Jing· 2025-08-14 02:48
Core Viewpoint - 康宁杰瑞制药-B expects to achieve a profit of no less than RMB 20 million for the six months ending June 30, 2025, compared to a loss of approximately RMB 44.9 million in the same period of 2024, indicating a turnaround from loss to profit driven by milestone revenues from three licensing collaborations and sales from commercialized products [1][1][1] Group 1 - Following the announcement, 康宁杰瑞制药-B's stock rose over 3%, currently trading at HKD 9.42 with a transaction volume of HKD 10.1093 million [1][1] - 广发证券 highlights the company's robust proprietary technology platform in ADC, bispecific antibodies, and multifunctional protein engineering, suggesting a strong differentiation in its internal pipeline [1][1] - The company’s pipeline includes various anti-tumor drugs at different stages of development, showcasing its potential for growth in the biopharmaceutical sector [1][1]