111 【重点政策】两部门：开展食品加工领域生物制造创新技术应用方向征集工作 工业和信息化部办公厅、国家卫生健康委办公厅8月19日发布《关于开展食品加工领域生物制造创新技 术应用方向征集工作的通知》。征集要求提到，围绕食品原料、食品添加剂、食品相关产品、食品及饮 料加工制造等领域，征集合成生物学、发酵工程、酶工程等生物制造创新技术应用方向和可能取得突破 的优秀实践案例。应用方向应符合"构建多元化食物供给体系"要求，对产业发展具有较强推广应用价 值，可参考《食品加工用遗传修饰微生物安全性评价申报材料要求（试行）》。应用方向还应满足以下 条件： 1、相关产品国内研发完成，已进入小批量试产或规模化生产阶段； 2、相关产品有充分研究成果证明其安全性，或在其他国家（地区）已通过相关审批，允许用于食品加 工生产； 3、相关产品已达到或即将达到国内"三新食品"（即新食品原料、食品添加剂新品种、食品相关产品新 品种）申报条件，但尚未获批。 【重点政策】海南出台举措支持生物医药产业发展 近日从海南省政府获悉，该省出台《海南省关于进一步支持生物医药产业高质量发展的若干政策措施》 （以下简称《措施》），持续加大创新药械研发支持力度 ...

Group 1 - Company and its subsidiaries received approval from the National Medical Products Administration for clinical trials of HRS-4508 tablets, SHR-A1811 injection, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - HRS-4508 is a novel, efficient, selective tyrosine kinase inhibitor that inhibits tumor cell proliferation [1] - The total R&D investment for HRS-4508 project is approximately 36.42 million yuan [1] Group 2 - SHR-A1811 injection binds to HER2-expressing tumor cells and induces apoptosis through a unique mechanism [2] - SHR-A1811 was approved for use in treating adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations [2] - The total R&D investment for SHR-A1811 project is approximately 1.26 billion yuan [2] Group 3 - Bevacizumab is a humanized anti-VEGF monoclonal antibody that has been approved in multiple countries since 2004 [3] - The global sales of Bevacizumab are projected to be approximately 5.655 billion USD in 2024 [3] - The total R&D investment for Bevacizumab injection project is approximately 3.45 million yuan [3]

公告显示，HRS—4508片是一种新型、高效、选择性的酪氨酸激酶抑制剂，通过抑制肿瘤细胞增殖发挥 抗肿瘤作用。注射用瑞康曲妥珠单抗（注射用SHR—A1811）可通过与HER2表达的肿瘤细胞结合并内 吞，在肿瘤细胞溶酶体内通过蛋白酶剪切释放毒素，诱导细胞周期阻滞从而诱导肿瘤细胞凋亡。阿得贝 利单抗注射液是恒瑞医药自主研发的人源化抗PD—L1单克隆抗体，能通过特异性结合PD—L1分子从而 阻断导致肿瘤免疫耐受的PD—1/PD—L1通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的 目的。贝伐珠单抗是一种人源化抗VEGF单克隆抗体。 北京商报讯（记者 王寅浩 实习记者 宋雨盈）8月18日，恒瑞医药发布公告称，公司及子公司苏州盛迪 亚生物医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局核准签发关于HRS—4508片、注 射用SHR—A1811、阿得贝利单抗注射液、贝伐珠单抗注射液的《药物临床试验批准通知书》，将于近 期开展临床试验。 ...

智通财经APP讯，恒瑞医药(600276.SH)公告，公司及子公司苏州盛迪亚生物医药有限公司、上海盛迪 医药有限公司收到国家药品监督管理局核准签发关于HRS-4508片、注射用SHR-A1811、阿得贝利单抗 注射液、贝伐珠单抗注射液的《药物临床试验批准通知书》，将于近期开展临床试验，具体为：HRS- 4508联合其他抗肿瘤治疗HER2通路异常的实体瘤的开放、多中心的ⅠB/Ⅱ期临床研究。 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) and its subsidiaries have received approval from the National Medical Products Administration for clinical trials of multiple drugs, indicating a significant advancement in their oncology pipeline [1] Group 1: Clinical Trial Approvals - The company and its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd., have been granted clinical trial approval notices for HRS-4508 tablets, SHR-A1811 injection, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - The clinical trials will include an open-label, multicenter Phase I/II study of HRS-4508 in combination with other anti-tumor therapies for solid tumors with abnormal HER2 pathways [1]

Investment Rating - The report maintains a "Buy" rating for several companies in the biotechnology sector, including Legend Biotech (LEGN US), and others like 3SBio (1530 HK), Innovent Biologics (1801 HK), and more, indicating a positive outlook for these stocks [7]. Core Insights - The upcoming centralized procurement of biosimilars in mainland China is expected to impact multiple major products, with the first round of information collection already initiated [2]. - The report emphasizes that the impact of this procurement on company performance and product sales will likely be felt starting in 2026, as the process is expected to take longer due to the novelty of biosimilar procurement in China [2]. - Companies such as China Biologic Products, Innovent Biologics, and Hengrui Medicine are highlighted as key players with multiple products involved in the procurement process, warranting close attention to pricing and allocation results [2][3]. - The report suggests that the impact on innovative drugs will be limited, as the products involved in the procurement are off-patent and already have competing biosimilars [2]. Summary by Sections Section: Centralized Procurement - The centralized procurement for biosimilars is officially starting, with a focus on eight monoclonal antibody products [2]. - The information collection phase is expected to last 1-2 months, with a longer timeline anticipated for rule formulation and final product inclusion [2]. Section: Company Focus - Key companies to watch include China Biologic Products, Innovent Biologics, and Hengrui Medicine, with respective products in the procurement process [2]. - The report recommends monitoring the pricing and allocation outcomes closely for these companies [2]. Section: Innovative Drugs - The report indicates that the eight monoclonal antibodies involved in the procurement are already off-patent and have existing biosimilars, suggesting limited impact on innovative drugs still under patent [2]. - Continuous attention is advised for the upcoming national medical insurance negotiations and the establishment of commercial insurance innovative drug directories [2].

政策动向 国家卫健委印发《基孔肯雅热诊疗方案（2025年版）》 7月31日，国家卫生健康委办公厅联合国家中医药局综合司发布公告指出，为进一步指导各级各类医疗 机构做好基孔肯雅热医疗救治工作，提高规范化、同质化诊疗水平，我们在2008年发布的基孔肯雅热诊 断和治疗方案基础上，组织制定了基孔肯雅热诊疗方案（2025年版）。 最新方案显示，基孔肯雅热（Chikungunyafever，CHIK）是由基孔肯雅病毒（Chikungunyavirus， CHIKV）感染引起，经伊蚊叮咬传播的急性传染病。临床以发热、关节痛、皮疹为主要特征。基孔肯 雅热在全球热带和亚热带地区广泛流行，流行范围呈持续扩大趋势。我国伊蚊分布广泛，近年来已经发 生多起境外输入病例导致的本地传播疫情。 国家医保局发文，医保基金即时结算 7月31日，国家医保局办公室印发《基本医保基金即时结算经办规程（试行）》的通知，明确医保基金 即时结算业务流程。 21点评：即时结算是指按照基本医保基金预算管理和医疗费用结算管理的相关要求，通过压缩结算时 间、推进逐笔申报拨付、按月预拨等创新路径，向定点医药机构拨付医保资金的结算方式。 脑机接口再传重磅消息 7月31 ...

证券日报网讯 7月31日晚间，恒瑞医药发布公告称，近日，公司子公司苏州盛迪亚生物医药有限公司、 上海盛迪医药有限公司收到国家药品监督管理局核准签发关于SHR-8068注射液、阿得贝利单抗注射 液、贝伐珠单抗注射液的《药物临床试验批准通知书》，将于近期开展临床试验。 （文章来源：证券日报） ...

Performance Updates - 开拓药业-B (09939.HK) has completed patient enrollment for the Phase III clinical trial of KX-826 solution for androgenetic alopecia in adult males in China [2] - 李氏大药厂 (00950.HK) has received approval from the National Medical Products Administration for Socazolimab to be used in combination with chemotherapy for first-line treatment of extensive-stage small cell lung cancer in mainland China [2] - 恒瑞医药 (01276.HK) has received approval for clinical trials of SHR-8068 injection, Adebali monoclonal antibody injection, and Bevacizumab injection [2] - 恒瑞医药 (01276.HK) has also received approval to conduct clinical trials for HRS-5041, intended for prostate cancer treatment [2] - 深圳高速公路股份 (00548.HK) reported toll revenue of 106 million yuan for the outer ring project in June [2] - 大成生化科技 (00809.HK) has signed an EPC contract with Northeast Electric and Liaoning Electric for boiler renovation projects, with a maximum cost of 129.1 million yuan [2] - 小黄鸭德盈 (02250.HK) has signed a contract to develop an AI marketing system to diversify revenue sources [2] Buyback and Financing Activities - 威海银行 (09677.HK) plans to issue up to approximately 758 million domestic shares and 154 million H-shares, raising nearly 3 billion yuan [2] Financial Results - 香港电讯-SS (06823.HK) reported total revenue of 17.322 billion HKD for the first half, a year-on-year increase of 4%, with a net profit of 2.07 billion HKD, also up 4% [4] - 青岛银行 (03866.HK) reported operating revenue of 7.662 billion yuan for the first half, a growth of 7.5%, and a net profit of 3.065 billion yuan, up 16.05% [4] - 中国石油化工股份 (00386.HK) expects mid-term net profit to be between 20.1 billion and 21.6 billion yuan, a year-on-year decline of 39.5%-43.7% [4] - 汽车之家-S (02518.HK) reported total revenue of 3.212 billion yuan for the first half, a decrease of 7.75%, with a net profit of 772 million yuan, down 15.99% [4] - 绿茶集团 (06831.HK) issued a profit warning, expecting mid-term net profit to be between 230 million and 237 million yuan, a year-on-year increase of approximately 32%-36% [4] - 粤海置地 (00124.HK) issued a profit warning, expecting mid-term net profit to exceed 260 million HKD, turning from loss to profit [4] - 药师帮 (09885.HK) issued a profit warning, expecting mid-term net profit to exceed 70 million yuan [4] - 中国东方教育 (00667.HK) issued a profit warning, expecting mid-term net profit to grow by 45%-50% year-on-year [4] - 中核国际 (02302.HK) issued a profit warning, expecting mid-term revenue to increase to at least 585 million HKD, with net profit of at least 9.5 million HKD [4] - 大唐环境 (01272.HK) issued a profit warning, expecting mid-term net profit to decrease to between 350 million and 400 million yuan [4] - 长江生命科技 (00775.HK) issued a profit warning, expecting mid-term net loss of approximately 150 million HKD, turning from profit to loss year-on-year [4] - 延长石油国际 (00346.HK) issued a profit warning, expecting mid-term loss of approximately 27.9 million HKD [4]

公告显示，SHR—8068注射液是恒瑞医药引进的一款全人源抗CTLA—4单克隆抗体，可增强抗肿瘤免 疫效应；阿得贝利单抗注射液是恒瑞医药自主研发的人源化抗PD—L1单克隆抗体，能通过特异性结合 PD—L1分子从而阻断导致肿瘤免疫耐受的PD—1/PD—L1通路，重新激活免疫系统的抗肿瘤活性，从而 达到治疗肿瘤的目的；贝伐珠单抗是一种人源化抗VEGF单克隆抗体。 北京商报讯(记者王寅浩实习记者宋雨盈)7月31日，恒瑞医药（600276）发布公告称，公司子公司苏州 盛迪亚生物医药有限公司、上海盛迪医药有限公司收到国家药品监督管理局核准签发的关于SHR—8068 注射液、阿得贝利单抗注射液、贝伐珠单抗注射液的《药物临床试验批准通知书》，将于近期开展临床 试验。 ...