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]

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]