Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has announced the acceptance of a new drug application for KN026 in collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group Co., Ltd. This application targets HER2-positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma patients who have failed at least one systemic treatment, including trastuzumab combined with chemotherapy [1][2]. Group 1 - The new drug application is based on a pivotal Phase II/III clinical trial, which demonstrated that KN026 combined with chemotherapy significantly improves clinical efficacy compared to existing standard treatments, extending progression-free survival (PFS) and overall survival (OS) without new safety risks [1]. - KN026 has received breakthrough therapy designation from the National Medical Products Administration (NMPA) and has been granted priority review qualification, with the application date set for August 28, 2025 [1]. Group 2 - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, making KN026 the first anti-HER2 bispecific antibody drug in China to achieve positive results in this indication [2]. - The Phase II clinical trial results, to be presented at the 2024 European Society for Medical Oncology (ESMO) annual meeting, show an objective response rate of 40.0% and a median PFS of 8.6 months as assessed by an independent review committee [2]. - KN026 aims to become a next-generation HER2-targeted therapy globally, utilizing an innovative structure that binds to two different clinically validated HER2 epitopes, enhancing tumor-killing effects through various mechanisms [2].

ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 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之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 KN026（安尼妥單抗注射液）新藥上市申請獲國家藥監局受理 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作 出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，與石藥集團有限公司（股份代號： 1093）附屬公司上海津曼特生物科技有限公司合作開發的KN026聯合化療用於治 療至少接受過一種系統性治療（必須包含曲妥珠單抗聯合化療）失敗的人表皮生長 因子受體2（「HER2」）陽性（「HER2+」）局部晚期、復發或轉移性胃 ╱ 胃 － 食管 結合部腺癌（「GC/GEJ」）患者的新藥上市申請（「新藥上市申請」），已獲中華人民 共和國（「中國」）國家藥品監督管理局（「國家藥監局」）受理。本次新藥上市 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 康寧傑瑞生物製藥 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09966 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 25,100,000,000 | USD | 0.000002 | USD | | 50,200 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 25,100,000,000 | USD | 0.000002 | USD | | 50,200 | 本月底法定/註冊股本總額： USD 50 ...

Core Viewpoint - 康宁杰瑞制药-B reported significant financial improvements in its mid-term results, indicating strong growth and recovery from previous losses [2] Financial Performance - The company achieved a revenue of 319 million RMB for the six months ending June 30, 2025, representing an increase of 84.05% year-on-year [2] - The net profit for the period was 21.575 million RMB, a turnaround from a loss of 44.896 million RMB in the same period last year, indicating a successful recovery [2] - Basic earnings per share were reported at 0.02 RMB [2] Research and Development - R&D expenditures increased from 194.5 million RMB for the six months ending June 30, 2024, to 253.2 million RMB for the current reporting period, an increase of 58.7 million RMB [2] - The rise in R&D spending is attributed to the increase in the number of ongoing clinical trials, expansion of clinical research scale, and progress in clinical trials for candidate drugs [2]

Core Viewpoint - Corning Pharmaceutical-B (09966) experienced a significant stock price increase of 8.86%, reaching HKD 10.08, with a trading volume of HKD 18.195 million following the release of its interim results for the six months ending June 30, 2025 [1] Financial Performance - The company reported a revenue of RMB 319 million, representing an 84.05% year-on-year increase [1] - The net profit for the period was RMB 21.575 million, a turnaround from a loss of RMB 44.896 million in the same period last year, indicating a successful recovery [1] - Basic earnings per share were reported at RMB 0.02 [1] Research and Development Expenditure - R&D expenses increased from RMB 194.5 million for the six months ending June 30, 2024, to RMB 253.2 million for the current reporting period, an increase of RMB 58.7 million [1] - The rise in R&D spending is attributed to an increase in the number of ongoing clinical trials, expansion of clinical research scale, and progress in clinical trials for candidate drugs [1]

Core Insights - Corning Pharmaceutical-B (09966.HK) reported a revenue of RMB 319 million for the six months ending June 30, 2025, representing an 84.1% year-on-year increase [1] - The gross profit reached RMB 288 million, marking a 101.9% year-on-year growth [1] - The profit attributable to the company's owners for the period was RMB 21.575 million [1] - Research and development expenses amounted to RMB 253 million, compared to RMB 195 million in the same period last year [1] Group 1: R&D and Product Pipeline - The company has a highly differentiated internal pipeline consisting of ADCs, monoclonal antibodies, and bispecific antibodies at various stages of development, including one product approved by the National Medical Products Administration and several in Phase III or pivotal clinical trials [1] - The depth and breadth of the company's independent R&D and manufacturing capabilities are highlighted by its structural-guided protein engineering capabilities, allowing for the development of various protein constructs, including single-domain antibodies (sdAb) and engineered proteins [2] - The company has proprietary platforms such as the sdAb platform, CRIB platform, glycan-specific conjugation platform, linker-payload platform, subcutaneous high-concentration formulation platform, and glycan-specific conjugation bispecific payload platform [2] Group 2: Manufacturing Capacity - The company is enhancing its manufacturing capabilities by designing and constructing new facilities that comply with the current Good Manufacturing Practice standards of the National Medical Products Administration, European Medicines Agency, and FDA, with an expected total capacity exceeding 40,000 liters [2] - A newly built ADC bulk and formulation production workshop has already commenced operations, adding to the existing production capacity [2]

Group 1 - The company reported a revenue of 319 million RMB for the six months ending June 30, 2025, representing a year-on-year increase of 84.05% [1] - The company achieved a profit of 21.575 million RMB during the period, compared to a loss of 44.896 million RMB in the same period last year, indicating a turnaround to profitability [1] - The basic earnings per share for the company were 0.02 RMB [1]

[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

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]

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]