Core Viewpoint - Heng Rui Medicine (600276) has seen its stock price increase by over 3%, currently trading at 68.75 HKD with a transaction volume of 71.27 million HKD, following the acceptance of two drug application submissions by the National Medical Products Administration (NMPA) [1] Group 1: Drug Approvals - The company's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., received an acceptance notice from the NMPA for the marketing authorization application of HR20013, an injectable drug for preventing nausea and vomiting caused by moderately emetogenic anticancer drugs, based on a Phase III clinical trial [1] - Heng Rui Medicine and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., also received an acceptance notice for the marketing authorization application of a new indication for the innovative drug SHR-1210 (injectable carrelizumab) in combination with apatinib, based on a Phase III clinical trial comparing the efficacy and safety of the combination treatment against TACE alone for patients with unresectable hepatocellular carcinoma [1]

Core Viewpoint - Heng Rui Medicine (01276) has seen its stock price increase by over 3%, currently trading at HKD 68.75, with a transaction volume of HKD 71.27 million [1] Group 1: Regulatory Approvals - The company's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration (NMPA) for the marketing authorization application of HR20013, an injectable drug for preventing nausea and vomiting caused by moderately emetogenic anticancer drugs [1] - The application for HR20013 is based on a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial (HR20013-302) evaluating its efficacy and safety [1] Group 2: New Indications for Existing Drugs - Heng Rui Medicine and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., have also received a "Notice of Acceptance" from the NMPA for the marketing authorization application of a new indication for the innovative drug, SHR-1210 (injectable carrelizumab) in combination with apatinib mesylate tablets [1] - This application is based on a randomized controlled, open-label, multicenter Phase III clinical trial (SHR-1210-III-336 study) comparing the efficacy and safety of carrelizumab and apatinib combined with TACE versus TACE alone in patients with unresectable hepatocellular carcinoma [1]

恒瑞医药(01276.HK)2月4日耗资931.7万元回购16.5万股A股 恒瑞医药(01276.HK)：福建盛迪医药"注射 用磷罗拉匹坦帕洛诺司琼"药品上市许可申请获受理 相关事件 格隆汇2月4日丨恒瑞医药(01276.HK)发布公告，2026年2月4日耗资人民币931.70万元回购16.5万股A 股，回购价格每股56.25-57.09元。 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司福建盛迪医药有限公司收到国家药品监督 管理局（以下简称"国家药监局"）下发的《受理通知书》，公司注射用磷罗拉匹坦帕洛诺司琼 （HR20013）的药品上市许可申请获国家药监局受理。现将相关情况公告如下： 一、药品的基本情况 受理号：CXHS2600019 申报阶段：上市 申请人：福建盛迪医药有限公司 拟定适应症（或功能主治）：本品用于成年患者预防中度致吐性抗肿瘤药物引起的急性和迟发性恶心和 呕吐。 二、药品的临床试验情况 此次申报新适应症，是基于一项评价注射用磷罗拉匹坦帕洛诺司琼用于预防中度致吐性抗肿瘤药物引起 恶心呕吐的有效性和安全性的多中心、随机、双盲、阳性对照的Ⅲ期临床试验（HR20013-302）。该研 究由中山大学肿瘤防治中心作为牵头单位，张力教授和李宇红教授担任主要研究者，全国96家临床研究 中心共同参与，共随机入组706例受试者。研究主要终点和关键次要终点分别为中 ...

药品名称：注射用磷罗拉匹坦帕洛诺司琼 剂型：注射剂 格隆汇1月30日丨恒瑞医药(01276.HK)近日，江苏恒瑞医药股份有限公司子公司福建盛迪医药有限公司 收到国家药品监督管理局下发的《受理通知书》，公司注射用磷罗拉匹坦帕洛诺司琼(HR20013)的药品 上市许可申请获国家药监局受理。 受理号：CXHS2600019 申报阶段：上市 拟定适应症(或功能主治)：本品用于成年患者预防中度致吐性抗肿瘤药物引起的急性和迟发性恶心和呕 吐。 申请人：福建盛迪医药有限公司 ...

恒瑞医药(600276.SH)公告称，公司子公司福建盛迪医药有限公司收到国家药监局下发的《受理通知 书》，公司注射用磷罗拉匹坦帕洛诺司琼的药品上市许可申请获国家药监局受理。该药品用于成年患者 预防中度致吐性抗肿瘤药物引起的急性和迟发性恶心和呕吐。注射用磷罗拉匹坦帕洛诺司琼为复方制 剂，可同时激活NK-1受体和5-HT3受体双途径抑制呕吐反射。目前国内暂无同类注射剂获批上市。该项 目累计研发投入约2.47亿元。 ...

Core Insights - The biopharmaceutical industry is a key strategic emerging industry in Xiamen, Fujian Province, with over 1,800 companies expected by the end of 2025 and an industry scale nearing 100 billion yuan [1] - Xiamen has approved 8 new Class 1 drugs and over 60 new drug varieties for registration or clinical trials, along with 72 Class 3 medical devices, accounting for 90% of the total in Fujian Province [1] Regulatory Support - Xiamen's market regulatory authority emphasizes integrating regulation with service to support high-level innovation in the biopharmaceutical sector [1] - The Xiamen Market Supervision Administration has been enhancing regulatory capabilities, cultivating professional talent, and optimizing industry services to foster a high-quality development ecosystem [1] Technical Support and Quality Assurance - The Xiamen Food and Drug Quality Inspection Institute has successfully entered the national drug sampling quality analysis现场评议环节, having completed over 5,500 batches of sampling tasks since 2009 [2] - The institute is enhancing its inspection and testing capabilities through partnerships in research and development, focusing on cutting-edge technologies like cell and gene testing [2][3] - A new medical device testing center is under construction to meet the growing demand for testing in the biopharmaceutical industry, aiming to cover over 90% of the city's testing needs [3] Talent Development - The Xiamen Market Supervision Administration has implemented a comprehensive training system to enhance the professional skills of drug inspectors, with 183 inspectors certified by the end of last year [5][6] - The administration has established a "1+N" training system, organizing multiple training sessions to improve the regulatory workforce's capabilities [5][6] Industry Collaboration and Efficiency - The Xiamen Market Supervision Administration has facilitated faster product approvals, exemplified by the early approval of a drug by Fengdi Pharmaceutical, which benefited from professional guidance [7] - A dedicated working group has been established to support the high-quality development of the biopharmaceutical industry, streamlining administrative processes for over 60 licensing items [7][8] - Collaborative measures have been introduced to support the biopharmaceutical industry, including 20 initiatives focused on R&D innovation, clinical trials, and regulatory approvals [8]

Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the new National Medical Insurance Directory and the first Commercial Health Insurance Innovative Drug Directory, set to be implemented nationwide from January 1, 2026 [1][2] Summary by Sections National Medical Insurance Directory - A total of 114 new drugs have been added to the National Medical Insurance Directory, with 111 of them being new products launched within the last five years, representing 97.3% of the new additions [2] - Among the new drugs, 50 are classified as Category 1 innovative drugs, with a success rate of 88%, an increase from 76% in 2024 [2] - The total number of drugs in the directory has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [2] Company Announcements - Several listed companies, including Heng Rui Medicine, Fosun Pharma, and Hai Si Ke, announced new drug inclusions or renewals in the updated National Medical Insurance Directory [3] - Heng Rui Medicine reported that 20 products/indications were included, with significant coverage across various diseases such as tumors and cardiovascular conditions [3][4] - Hai Si Ke's two Category 1 innovative drugs were included, with one being a new addition and the other a renewal [4] Commercial Health Insurance Innovative Drug Directory - The first Commercial Health Insurance Innovative Drug Directory includes 19 new drugs from 18 innovative pharmaceutical companies, with 9 being Category 1 innovative drugs [7] - Notably, five CAR-T products were included, representing over half of the CAR-T products available in China, which previously faced challenges in entering the insurance market due to high pricing [7][8] - The directory also includes treatments for rare diseases and high-profile conditions such as Alzheimer's disease, enhancing the complementarity with the basic medical insurance [7][10] Notable Drug Inclusions - The directory includes drugs for significant diseases such as triple-negative breast cancer and pancreatic cancer, as well as treatments for rare diseases like Gaucher disease [5][9] - In the diabetes sector, several domestic drugs were newly included, such as a long-acting GLP-1 receptor agonist [6] - Companies like Bei Hai Kang Cheng and Bai Ji Shen Zhou have also successfully included their innovative drugs in the Commercial Health Insurance Directory [9]

Core Points - The company has successfully included several of its products in the National Medical Insurance Catalog for 2025, which is expected to enhance sales and improve operational performance [1] - The total estimated sales for the included drugs in 2024 is approximately 8.66 billion yuan, and for the first three quarters of 2025, it is about 7.55 billion yuan [1] Drug Inclusion in National Medical Insurance Catalog - The following drugs have been newly included: - Injection of Rukang Qutuzumab - Apixaban Famitinib Capsules - Injection of Funaqi Zhumab - Sulfate of Amatuximab Tablets - Injection of Phosphorola Pitant Palonosetron - Injection of Ruikasi Zhumab - Acetate of Abiraterone Tablets (II) - Lipid Injection of Irinotecan Hydrochloride (II) - Regaglitin Metformin Tablets (I)/(II) - Perfluorohexyl Octane Eye Drops [1] - The following drugs have successfully added new indications: - Injection of Karelizumab - Fluorazepam Capsules - Injection of Fumaric Acid Tegafur [1] - The following drugs have been renewed and retained in the National Medical Insurance Catalog: - Maleate of Pyrotinib Tablets - Hecorapam Ethanolamine Tablets - Phosphate of Regaglitin Tablets - Injection of Methylsulfonylmethane Remazolam - Sulfate of Pevonedistat Injection [1] - The following drugs have new indications and have been adjusted to regular catalog management: - Mesylate of Apatinib Tablets - Lipid Injection of Bupivacaine [1] Impact on the Company - The inclusion of these drugs in the National Medical Insurance Catalog is expected to positively impact sales, although the exact effect on the company's operational performance is currently indeterminate [1] - The National Medical Insurance Catalog will officially take effect on January 1, 2026, with further details on payment standards and reimbursement rules to be announced by relevant government departments [1]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has announced that several of its products have been included in the National Medical Insurance Directory, which is expected to positively impact sales and overall business performance in the future [1][2]. Group 1: Inclusion of Products in National Medical Insurance Directory - The following products have been newly included in the National Medical Insurance Directory: injection of Rukang Qutuzumab, Apixaban Famitinib capsules, injection of Funaqi Qutuzumab, Sulfate Amamxetine tablets, injection of Phosphororapitant Palonosetron, injection of Ruikasi monoclonal antibody, Acetate Abiraterone tablets (II), Liposomal Irinotecan injection (II), and Regaglitin Metformin tablets (I)/(II), as well as Perfluorohexyl Octane eye drops [2]. - Additional indications for injection of Karilizumab, Fluorouracil capsules, and injection of Fumagillin have successfully been added to the National Medical Insurance Directory [2]. - The renewal of the following products has been successfully retained in the National Medical Insurance Directory: Maleate Pyrrolidine tablets, Hecorapam Ethanolamine tablets, Phosphate Regaglitin tablets, injection of Toluene Sulfonate Remazolam, and Sulfate Pevotizumab injection [2]. Group 2: Financial Impact - The total sales of the aforementioned products for the year 2024 are estimated to be approximately 8.66 billion yuan, while the sales for the first three quarters of 2025 are projected to be around 7.55 billion yuan [2]. - The inclusion of these products in the National Medical Insurance Directory is expected to facilitate sales, although the exact impact on the company's operating performance cannot be estimated at this time [2].