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 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） 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，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 （股份代號：9966） 截至2025年6月30日止六個月中期業績公告 康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）董事（「董事」）會 （「董事會」）欣然宣佈本集團截至2025年6月30日止六個月（「報告期間」）的未經審 核簡明綜合業績，連同截至2024年同期的比較數字。 於本公告內，「我們」及「我們的」指本公司，並在文義另有所指時指本集團。本公 告所載若干數額及百分比數字已經四捨五入調整或以四捨五入取至小數點後一位 或兩位數。任何表格、圖表或其他地方所示總額與所列數額總和的任何差異乃因 四捨五入所致。 財務摘要 | | 截至6月30日止六個月 | | | --- | --- | --- | | | 2025年 | 2024年 | | | 人民幣千元 | 人民幣千元 | | | （未經審核） | （未經 ...

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]

此外，康宁杰瑞制药自主研发的程序性死亡配体1（PD-L1）/整合素αvβ6双特异性抗体偶联药物 （ADC）JSKN022的新药临床试验申请已获中国国家药品监督管理局药品审评中心正式受理。公司计划 开展用于治疗晚期恶性实体瘤的JSKN022首次人体临床研究。目前全球范围内尚无靶向整合素αvβ6或 PD-L1的ADC上市，相关在研药物均处于临床研究阶段。 消息面上，康宁杰瑞制药将于8月28日(下周四)召开董事会会议以审批中期业绩。公司此前预计，上半 年取得利润不少于人民币2000万元，去年同期亏损约人民币4490万元。公司于报告期内转亏为盈，主要 基于三项授权合作的里程碑收入和商业化产品的销售收入。 智通财经APP获悉，康宁杰瑞制药-B(09966)尾盘涨幅进一步扩大，截至发稿，涨14.03%，报10.81港 元，成交额7386.46万港元。 ...