Core Viewpoint - 康宁杰瑞制药-B's new drug application for KN026 has been accepted by the National Medical Products Administration of China, leading to a nearly 6% increase in stock price [1][2] Group 1: Company Developments - 康宁杰瑞制药-B's collaboration with Shanghai Jinmant Biotech, a subsidiary of CSPC Pharmaceutical Group, focuses on developing KN026 for HER2-positive gastric cancer patients who have failed at least one systemic treatment [1] - The new drug application is based on a pivotal Phase II/III clinical trial that demonstrated significant clinical efficacy compared to existing standard treatments, improving progression-free survival (PFS) and overall survival (OS) [2] - KN026 has received breakthrough therapy designation from the National Medical Products Administration and has been granted priority review status [2] Group 2: Clinical Trial Results - The Phase II clinical trial results showed an objective response rate of 40.0% for KN026 in combination with chemotherapy, with a median PFS of 8.6 months as assessed by an independent review committee [2] - KN026 is the first bispecific antibody drug in China to achieve positive results in second-line treatment for HER2-positive gastric cancer, where no anti-HER2 drugs have been approved for this indication [2]

Major Events - Alibaba-W (09988) announced the pricing of $3.2 billion zero-coupon convertible preferred notes, with an initial conversion price of $193.15 per American depositary share [1] - Peijia Medical-B (09996) reported the first human clinical trial implantation of the Sutra Hemi-valve transcatheter mitral valve repair system [1] - Corning Jereh Pharmaceutical-B (09966) received acceptance from the National Medical Products Administration for the new drug application of KN026 (Anni monoclonal antibody injection) [1] - Nissin Foods (01475) invested 30.68 million yuan to acquire two plots of land in Zhuhai for the construction of new production facilities [1] - Nocoda Technology (00519) signed a cooperation agreement for low-altitude economic intelligent drones [1] Financial Data - Country Garden Holdings (00754) reported total contract sales of approximately 9.902 billion yuan for the first eight months, a year-on-year decrease of 15.56% [1] - China General Nuclear Power Corporation (01811) completed a power generation of 1,543.7 GWh in August, a year-on-year decrease of 5.7% [1] - Xinte Energy (00956) achieved a cumulative power generation of 9.8787 million MWh in the first eight months, a year-on-year increase of 10.55% [1] - Oceanwide Holdings (03377) reported a cumulative contracted sales amount of approximately 16.44 billion yuan for the first eight months, a year-on-year decrease of 25.88% [1]

Company News - New天绿色能源 (00956.HK) reported a power generation of 9.8787 million MWh in the first eight months, an increase of 10.55% year-on-year; August's power generation was 784.8 thousand MWh, up 23.53% year-on-year [2] -远洋集团 (03377.HK) recorded a contract sales amount of 16.44 billion yuan in the first eight months, a decrease of 25.9% year-on-year; August's contract sales were approximately 1.7 billion yuan, down 17.5% year-on-year [2] - 合生创展集团 (00754.HK) reported a contract sales amount of approximately 9.902 billion yuan in the first eight months, a decrease of 15.6% year-on-year; August's contract sales were about 334 million yuan, down 38.4% year-on-year [2] - 越秀交通基建 (01052.HK) reported a cumulative toll revenue of approximately 603 million yuan for the Guangzhou North Second Ring Expressway in the first seven months, a decrease of 0.7% year-on-year [2] - 华油能源 (01251.HK) entered into a financing lease agreement with Zhongguancun Science and Technology Leasing [2] - 日清食品 (01475.HK) plans to invest 30.68 million yuan to acquire land in Zhuhai for new production facilities [2] - 鲁大师 (03601.HK) subscribed to a structured deposit product from China Merchants Bank, involving 50 million yuan [2] - 越秀地产 (00123.HK) plans to obtain a term loan financing of 200 million HKD [2] - 康宁杰瑞制药-B (09966.HK) had its new drug application for KN026 (Anituzumab injection) accepted by the National Medical Products Administration [2] Buyback Activities - 腾讯控股 (00700.HK) repurchased 874,000 shares at a cost of 550 million HKD, with repurchase prices ranging from 624 to 633 HKD [2] - 汇丰控股 (00005.HK) spent approximately 108 million HKD to repurchase about 1.041 million shares, with repurchase prices between 102.8 and 104.3 HKD [2] - 恒生银行 (00011.HK) repurchased 210,000 shares at a cost of approximately 24.882 million HKD, with repurchase prices from 117.9 to 119.2 HKD [2] - 百胜中国 (09987.HK) repurchased about 57,900 shares at a cost of approximately 20.2 million HKD, with repurchase prices between 347 and 351.8 HKD [2] - 石四药集团 (02005.HK) repurchased 6 million shares at a cost of approximately 18.143 million HKD, with repurchase prices ranging from 2.98 to 3.04 HKD [2] - 美高梅中国 (02282.HK) repurchased 1 million shares at a cost of 16.2463 million HKD, with repurchase prices between 16.04 and 16.45 HKD [3] Power Generation Data - 中广核新能源 (01811.HK) reported a power generation of approximately 12,850.5 GWh in the first eight months, a decrease of 1.6% year-on-year; August's power generation was 1,543.7 GWh, down 5.7% year-on-year [4]

Core Viewpoint - Corning Jereh Pharmaceutical-B (9966.HK) has announced that its new drug application for KN026, a combination chemotherapy treatment for HER2-positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma patients who have failed at least one systemic therapy, has been accepted by the National Medical Products Administration of the People's Republic of China [1] Group 1 - KN026 is the first bispecific antibody drug in China to achieve positive results in second-line treatment for gastric cancer [1] - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer [1]

Group 1 - Corning Jereh Pharmaceutical-B (09966) announced that its new drug application for KN026, in collaboration with Shanghai Jinmant Biotech Co., Ltd., has been accepted by the National Medical Products Administration of China for treating HER2-positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma patients who have failed at least one systemic treatment including trastuzumab-based chemotherapy [1] - The new drug application is based on a pivotal phase II/III clinical trial, which showed that KN026 combined with chemotherapy significantly improved clinical efficacy compared to existing standard treatments, extending progression-free survival (PFS) and overall survival (OS) without new safety risks, low incidence of cardiac toxicity, and low immunogenicity [1] - KN026 received breakthrough therapy designation from the National Medical Products Administration on November 4, 2023, and was granted priority review qualification on 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 for KN026 will be presented at the 2024 European Society for Medical Oncology annual meeting, showing an objective response rate of 40.0% and a median PFS of 8.6 months as assessed by an independent review committee [2]

Core Insights - Corning Jereh Pharmaceutical-B (09966) has received acceptance for its new drug application for KN026, a combination chemotherapy treatment for HER2-positive gastric cancer patients who have failed at least one systemic therapy, from the National Medical Products Administration of China [1] - The application is based on a pivotal Phase II/III clinical trial that demonstrated significant clinical efficacy, prolonging progression-free survival (PFS) and overall survival (OS) compared to existing standard treatments, with a low incidence of cardiac toxicity and immunogenicity [1] - KN026 is the first bispecific antibody drug in China to achieve positive results in second-line treatment for HER2-positive gastric cancer, with an objective response rate of 40.0% and a median PFS of 8.6 months reported at the 2024 European Society for Medical Oncology annual meeting [2] Company Developments - The collaboration between Corning Jereh Pharmaceutical and Shanghai Jinmant Biotech, a subsidiary of CSPC Pharmaceutical Group (01093), is focused on the development of KN026 [1] - KN026 has been granted breakthrough therapy designation by the National Medical Products Administration and has received priority review status, indicating its potential significance in treating gastric cancer [1] Industry Context - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, highlighting the market opportunity for KN026 [2] - The positive clinical trial results for KN026 may pave the way for its adoption in clinical practice, addressing an unmet medical need in the treatment of gastric cancer [2]

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]