10月17日，省政府新闻办举行河南省高质量完成"十四五"规划系列主题新闻发布会第十五场发布会，全 面介绍我省市场监管系统总体发展情况，并回答记者提问。 在省委、省政府正确领导下，全省市场监管系统牢固树立当好经营主体"娘家人"、统一大市场"构建 人"、消费者权益"代言人"、优化营商环境"责任人"的工作理念，围绕"大市场、大质量、大安全"，统 筹打好强主体、提质量、稳秩序、保安全组合拳，推动"十四五"市场监管规划目标任务顺利完成，为全 省经济社会高质量发展提供有力支撑。 数据显示，"十四五"以来，我省新增经营主体367.5万户，较"十三五"末增长47%。截至今年9月底，全 省经营主体总数达1148.7万户，居全国第4位。 建强大市场 实施高价值专利培育计划、商标和地理标志品牌建设工程，激发创新主体活力。"十四五"期间，我省新 增有效发明专利52855件、注册商标110.39万件，国家地理标志保护产品59件，120个农产品地理标志成 功转化为地理标志保护产品，全省地理标志保护产品数量达241件，获得中国专利奖98项，评选2届河南 省专利奖。 筑牢大安全 "十四五"期间，全省市场监管系统以"零容忍"态度防风险、保安全 ...

Core Viewpoint - Heng Rui Medicine (01276) experienced a significant stock price increase, with a rise of over 4% at the close, and a current price of HKD 87.95, with a trading volume of HKD 217 million [1] Group 1: Clinical Trials and Approvals - Heng Rui Medicine announced the approval to conduct clinical trials for SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection [1] Group 2: Licensing Agreement - The company granted Glenmark, an Indian pharmaceutical company, exclusive rights to develop and commercialize its HER2 antibody-drug conjugate, Trastuzumab deruxtecan, in global non-core markets, receiving an upfront payment of USD 18 million and potential milestone payments exceeding USD 1 billion [1] Group 3: Market Rights and Financial Impact - Nomura's report indicates that Heng Rui retains development and commercialization rights for Trastuzumab deruxtecan in major pharmaceutical markets including Greater China, the US, Canada, Europe, and Japan, suggesting that the upfront payment will have a minimal financial impact, but the overall milestone payment scale could be substantial [1] - The collaboration with Glenmark is expected to help unlock the commercial potential of the product, and retaining rights in key markets provides opportunities for larger-scale partnerships in the future [1]

Core Viewpoint - Heng Rui Medicine (600276)(01276) experienced a significant stock price increase, with a rise of over 4% at the close, and currently trading at 87.95 HKD with a transaction volume of 217 million HKD. The company announced the approval for clinical trials of several injection products, indicating a positive development in its product pipeline [1]. Group 1: Clinical Trials and Product Development - Heng Rui Medicine announced the approval for clinical trials of SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection, showcasing its ongoing commitment to expanding its product offerings [1]. - The company granted exclusive rights to Indian pharmaceutical company Glenmark for the development and commercialization of its HER2 antibody-drug conjugate, Rukang Trastuzumab, in global non-core markets, receiving an upfront payment of 18 million USD and potential milestone payments exceeding 1 billion USD [1]. Group 2: Financial Impact and Market Strategy - Nomura's research report indicates that the upfront payment is not expected to have a significant impact on the company's finances, but the overall scale of milestone payments could be substantial [1]. - The retention of development and commercialization rights for Rukang Trastuzumab in major pharmaceutical markets such as Greater China, the US, Canada, Europe, and Japan is anticipated to provide opportunities for larger-scale collaborations with other potential partners in the future [1].

Core Viewpoint - Bidafarma, a well-known innovative pharmaceutical company, is planning to list on the Hong Kong Stock Exchange to enhance its capital strength and international competitiveness [2]. Company Overview - As of September 29, Bidafarma's A-share market capitalization is 27.68 billion yuan [2]. - The company focuses on developing innovative targeted therapies for various cancers, including lung, breast, kidney, colorectal, and pancreatic cancers, as well as blood diseases and ophthalmology [2]. Fundraising Purpose - The funds raised from the IPO will be allocated to four main areas: 1. Financing for the research and development of innovative drug candidates 2. Funding for potential acquisitions to expand the pipeline and develop Bidafarma's innovative ecosystem 3. Strengthening the marketing network and market expansion in key therapeutic areas 4. Working capital and other general corporate purposes [2]. Product Pipeline - Bidafarma has successfully launched eight innovative targeted cancer therapies and biosimilars, with over ten innovative drug development projects at various stages [2]. - The eight core products include: 1. Hydrochloride Ercitinib Tablets 2. Hydrochloride Ensatinib Capsules 3. Bevacizumab Injection 4. Mesylate Bafetinib Capsules 5. Voronib Tablets 6. Tarceva Capsules 7. Trastuzumab Injection 8. Recombinant Human Albumin Injection (Rice) - Among these, Hydrochloride Ercitinib Tablets, Hydrochloride Ensatinib Capsules, Voronib Tablets, and Tarceva Capsules are self-developed products, while the other four are collaborative products [2]. Financial Performance - In the first half of 2025, Bidafarma reported a revenue of 1.731 billion yuan, representing a year-on-year increase of 15.37%. However, the net profit attributable to shareholders decreased by 37.53% to 140 million yuan [3]. - The company emphasizes a proven and repeatable success model that integrates commercialization, research and development, strategic partnerships, and an innovative ecosystem, which collectively drive its transformation from a domestic pioneer to a globally competitive platform pharmaceutical company [3].

Major Events - Lai Kai Pharmaceutical-B (02105) reported positive preliminary results from Phase I clinical MAD study, with LAE102 showing encouraging trends in muscle gain and fat loss [1] - Fuhong Hanlin (02696) received FDA approval for the Phase I clinical trial application of HLX13 for first-line treatment of unresectable hepatocellular carcinoma (HCC) patients [1] - Ningmeng Media (09857) has commenced filming the urban medical emotional drama "Asking Heart 2" [1] - CRRC Corporation (01766) and its subsidiaries signed significant contracts totaling approximately 54.34 billion [1] - Heng Rui Pharmaceutical (01276) received approval to conduct clinical trials for SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection [1] - Hema Medical (03309) entered into a tripartite global licensing and collaboration agreement with Gilead and Hanmi regarding enecuidar [1] - Jinfang Pharmaceutical-B (02595) completed the enrollment of the first patient in the Phase I/II clinical trial of the molecular glue Pan RAS(ON) inhibitor GFH276 for RAS mutant cancer patients [1] - Gao Shi Medical (02407) obtained international certification for its medical device quality management system [1] Operating Performance - Shenzhen Expressway Company (00548) reported toll revenue of 114 million for the Outer Ring project in August [1] - China National Automobile (00026) announced an annual performance with a post-tax loss attributable to shareholders of 185 million HKD, a year-on-year reduction of 29.64% [1] - OKURA HOLDINGS (01655) reported an annual profit attributable to shareholders of 1.342 billion JPY, a year-on-year decrease of 34.34% [1] - Elephant Future Group (02309) disclosed an annual performance with a loss attributable to owners of approximately 314 million HKD, a year-on-year increase of 71.77% [1] - Henghe Group (00513) reported an annual performance with a loss attributable to owners of approximately 259 million HKD, a year-on-year increase of 0.7% [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four injectable drugs, indicating a significant advancement in its oncology pipeline [1][2]. Group 1: Drug Approvals and Clinical Trials - The company’s subsidiaries have been granted approval for clinical trials of SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody injections [1]. - SHR-7787 is a first-class therapeutic biological product aimed at activating T cells to target and kill tumor cells, with a cumulative R&D investment of approximately 48.93 million yuan [1]. - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors, with a cumulative R&D investment of about 69.67 million yuan [1]. Group 2: Market Context and Competitors - Bevacizumab, a humanized anti-VEGF monoclonal antibody, has a global sales forecast of approximately 5.655 billion USD for 2024, with the company’s related R&D investment totaling around 348.89 million yuan [2]. - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, was approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer, with a cumulative R&D investment of about 939.08 million yuan [2]. - Competing products in the market include Atezolizumab, Avelumab, and Durvalumab, which collectively have a global sales forecast of approximately 9.648 billion USD for 2024 [2].

Core Insights - 恒瑞医药's subsidiaries have received approval from the National Medical Products Administration for clinical trials of four injectable drugs, including SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody [1][2] Group 1: SHR-7787 and SHR-4849 - SHR-7787 is a first-class therapeutic biological product that activates T cells to target and kill tumor cells, with no similar drugs approved in China to date. The total R&D investment for SHR-7787 is approximately 48.93 million yuan [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors, with no similar drugs approved in China or abroad. The total R&D investment for SHR-4849 is approximately 69.67 million yuan [1] Group 2: Bevacizumab and Adebali Monoclonal Antibody - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was approved in the U.S. in 2004 and has generated global sales of approximately 5.655 billion USD in 2024. The total R&D investment for Bevacizumab by the company is approximately 348.89 million yuan [2] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer. The total R&D investment for Adebali is approximately 939.08 million yuan, with similar products generating combined global sales of approximately 9.648 billion USD in 2024 [2]

Core Viewpoint - Recently, Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiaries have received approval from the National Medical Products Administration for clinical trials of several injection drugs, indicating progress in their oncology drug development pipeline [1]. Group 1: Clinical Trial Approvals - Hengrui Medicine's subsidiaries, including Suzhou Sediya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have received clinical trial approval notices for SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection [1]. - The approved drugs will undergo clinical trials, with SHR-7787 injection being tested in a multicenter, open-label Phase II study in patients with malignant solid tumors [1]. Group 2: Regulatory Compliance - The approved drugs were reviewed and found to meet the requirements for drug registration as per the Drug Administration Law of the People's Republic of China, allowing for the commencement of clinical trials [1]. - The approval date for the drugs was noted as July 17, 2025, indicating a timeline for the regulatory process [1].

Core Viewpoint - Heng Rui Medicine announced the approval of clinical trial notifications for four injectable drugs by the National Medical Products Administration, indicating a significant advancement in its oncology pipeline [1] Group 1: Clinical Trial Approvals - The company’s subsidiaries received approval for SHR-7787, SHR-4849, Bevacizumab, and Atezolizumab for clinical trials [1] - SHR-7787 is a first-class therapeutic biological product that activates T cells to target and kill tumor cells [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors by specifically binding to DLL3 antigens on tumor cells [1] Group 2: Drug Mechanisms - Bevacizumab is a humanized anti-VEGF monoclonal antibody, commonly used in cancer treatment [1] - Atezolizumab is a humanized anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1]

Core Insights - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four injectable drugs, including SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody [1][2] Group 1: Drug Approvals - The company’s subsidiaries have been granted clinical trial approval for SHR-7787, a first-class therapeutic biological product that activates T cells to target and kill tumor cells, with no similar drugs currently approved in China [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to specifically bind to DLL3 antigens on tumor cells, leading to the release of cytotoxic agents to kill cancer cells, aimed at treating advanced malignant solid tumors [1] Group 2: Existing Products - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was co-developed by Genentech and is currently marketed globally, including in China [2] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody developed by the company, which aims to block the PD-1/PD-L1 pathway to reactivate the immune system against tumors [2]