Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a significant stock increase following the acceptance of its new drug application for KN026 by the National Medical Products Administration of China, aimed at treating HER2-positive gastric cancer patients who have failed previous treatments [1][2] Group 1: Company Developments - Corning Jereh Pharmaceutical-B's stock opened nearly 6% higher and is currently up 5.9%, trading at HKD 11.12 with a transaction volume of HKD 500,400 [1] - The new drug application for KN026, developed in collaboration with Shanghai Jinmant Biotech Co., a subsidiary of CSPC Pharmaceutical Group, targets patients with locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma who have undergone at least one systemic treatment [1] - The application is based on a pivotal Phase II/III clinical trial, which demonstrated significant clinical efficacy compared to existing standard treatments, extending both progression-free survival (PFS) and overall survival (OS) without new safety risks [1] Group 2: Clinical Trial Results - KN026 is the first bispecific antibody drug in China to achieve positive results in second-line treatment for HER2-positive gastric cancer [2] - The Phase II clinical trial results, to be presented at the 2024 European Society for Medical Oncology Congress, indicate an objective response rate of 40.0% and a median PFS of 8.6 months as assessed by an independent review committee [2]

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]

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]

智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，该公司与石药集团有限公司(01093)附属公司上海 津曼特生物科技有限公司合作开发的KN026联合化疗用于治疗至少接受过一种系统性治疗(必须包含曲 妥珠单抗联合化疗)失败的人表皮生长因子受体2(HER2)阳性(HER2+)局部晚期、复发或转移性胃/胃 - 食 管结合部腺癌(GC/GEJ)患者的新药上市申请(新药上市申请)，已获中国国家药品监督管理局(国家药监 局)受理。本次新药上市申请主要是基于一项关键II/III期临床试验，其期中分析结果显示，与现有标准 治疗相比，KN026联合化疗显著提高临床疗效，延长患者的无进展生存期(PFS)和总生存期(OS)，且在 安全性方面无新发安全性风险，心脏毒性发生率低，免疫原性低。此外，KN026已于2023年11月4日获 国家药监局药品审评中心授予突破性治疗药物认定，并已于2025年8月28日获优先审评审批资格。 该信息由智通财经网提供 目前，HER2+ 胃癌二线治疗尚无获批上市的抗HER2药物，KN026是中国首个在胃癌二线治疗中获得阳 性结果的抗HER2双特异性抗体药物。KN026的II期临床试验结果于2024 ...

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]

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 ...