（原标题：创新药临床试验审评审批增设30日通道；奥贝胆酸将在美国撤市） 康宁杰瑞制药-B：KN026(安尼妥单抗注射液)新药上市申请获国家药监局受理 这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 福建：力争在健康与新医药等领域率先突破，打造未来产业先导区 福建省人民政府近日印发《关于加快福建经济社会发展全面绿色转型的行动方案》。方案提出，推动绿色低碳产业发展壮大。围绕光电信息、集 成电路、新能源等优势领域，培育国家级战略性新兴产业集群，建好厦门生物医药港等专业化园区。创新发展未来产业，力争在数据智能、氢 能、前沿新材料、健康与新医药等领域率先突破，打造未来产业先导区。加强文化和旅游产业融合发展，支持武夷山、鼓浪屿建设世界级旅游景 区。到2030年，节能环保产业规模达到3000亿元左右。 创新药临床试验审评审批增设30日通道 9月12日，国家药监局发布实施《关于优化创新药临床试验审评审批有关事项的公告》（以下简称《公告》），创新药临床试验审评审批30日通道 支持国家重点研发品种，鼓励全球早期同步研发和国际多中心临床试验，服务临床急需和国家医药产业发展。 ...

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]

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 Viewpoint - The application for the new drug KN026 (Anituzumab Injection) developed by the company's subsidiary has been accepted by the National Medical Products Administration of China, targeting HER2-positive gastric cancer patients who have failed at least one systemic treatment [1][2]. Group 1 - The product is a bispecific antibody that targets two non-overlapping epitopes of HER2, leading to HER2 signal blockade [2]. - The objective response rate for the product in combination with chemotherapy is reported at 40.0%, with a median progression-free survival of 8.6 months and a median overall survival of 13.2 months based on the results of a Phase II clinical trial [2]. - The application is primarily based on a key Phase II/III clinical trial (KC-WISE), which shows significant clinical efficacy compared to current standard treatments, with no new safety risks identified [2]. Group 2 - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, making this product the first bispecific antibody to achieve positive results in this indication in China [2]. - The company is actively advancing multiple clinical trials for the product targeting different solid tumor indications, with gastric and breast cancer developments currently in critical Phase III clinical trial stages [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]