Core Viewpoint - The A-share market has reached a significant milestone with the Shanghai Composite Index surpassing 3,800 points, indicating a structural transformation driven by technology and innovation, particularly in the innovative pharmaceutical sector [1][2]. Company Overview - 康宁杰瑞制药 (Kangning Jereh) has emerged as a leading player in China's innovative drug industry, transitioning from a crisis to a strategic restructuring phase, focusing on core projects and enhancing its research and development capabilities [5][9]. - The company has successfully completed a strategic shift towards dual-targeted antibody drug conjugates (ADC), positioning itself for growth in the innovative drug development landscape [8][10]. Financial Performance - In the first half of 2025, 康宁杰瑞 reported revenue of 319 million yuan, a year-on-year increase of 84.05%, and a net profit of 21.58 million yuan, marking a return to profitability [22]. - The company's cash reserves reached 1.645 billion yuan, providing a solid financial foundation for future research and production [22]. Market Position and Potential - 康宁杰瑞's valuation is currently in a recovery phase, with its intrinsic value not fully recognized in the market, suggesting significant upside potential [23]. - The company is positioned favorably in the dual-targeted ADC sector, with its core products advancing ahead of industry peers, indicating a strong competitive edge [23]. Industry Context - The Chinese innovative drug sector is experiencing rapid growth, supported by favorable policies and a shift from imitation to independent innovation, with 康宁杰瑞 exemplifying this transition [20][25]. - The ongoing policy support for innovative drugs is expected to benefit companies with strong research capabilities and significant commercial potential [21].

Core Viewpoint - After a significant drop, Hong Kong's innovative drug concept stocks rebounded across the board, indicating market resilience and potential recovery in the sector [1] Group 1: Market Performance - As of the report, Kangning Jereh Pharmaceutical-B surged over 14%, Hutchison China MediTech rose more than 6%, Zai Lab and Lepu Biopharma B increased over 5%, and Akeso-B climbed over 4% [1] Group 2: Industry Sentiment - Several pharmaceutical companies have acknowledged rumors regarding potential restrictions from the U.S. on innovative drugs from China, but they believe these rumors do not currently impact the expectations for Chinese innovative drugs entering international markets [1] Group 3: Future Outlook - Market analysts predict that leading biotech companies such as BeiGene and Innovent Biologics are expected to reach a profitability inflection point by 2025, with a strong growth trajectory anticipated thereafter [1] - With improvements in industrial capabilities and product line expansions, it is expected that more biotech firms will enter a profitability cycle in the future [1]

康宁杰瑞制药-B(09966)高开近6%，截至发稿，涨5.9%，报11.12港元，成交额50.04万港元。 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。 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年欧洲肿瘤内科学会年会首次 公布，该结果显示，KN026联合化疗的客观缓解率为40.0%，经独立评审委员会评估的中位PFS为8.6个 月。 消息面上，康宁杰瑞制药-B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 ...

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。 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年欧洲肿瘤内科学会年会首次公布，该结果显示，KN026联合化疗的客观缓解率为40.0%，经独立评审委员会评 估的中位PFS为8.6个月。 智通财经APP获悉，康宁杰瑞制药-B(09966)高开近6%，截至发稿，涨5.9%，报11.12港元，成交额50.04万港元。 消息面上，康宁杰瑞制药-B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 ...

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]

格隆汇9月11日｜康宁杰瑞制药-B(9966.HK)公告，公司与石药集团有限公司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失败的人表皮生长因子受体 2阳性局部晚期、复发或转移性胃╱胃-食管结合部腺癌患者的新药上市申请，已获中华人民共和国国家 药品监督管理局受理。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。 ...

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]

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].