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]

Group 1 - The core point of the article is that Heng Rui Medicine (01276.HK) announced a share buyback on February 4, 2026, spending RMB 9.317 million to repurchase 165,000 A-shares at a price range of RMB 56.25 to 57.09 per share [1][1][1] Group 2 - Heng Rui Medicine's share buyback reflects the company's strategy to enhance shareholder value and confidence in its stock performance [1] - The company has also received acceptance for the marketing authorization application of "Injectable Phosphorlorapitant Palonosetron" from Fujian Shengdi Medicine [1]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received acceptance from the National Medical Products Administration for the marketing authorization application of HR20013, an injectable drug for preventing nausea and vomiting caused by moderately emetogenic chemotherapy in adult patients [1][2]. Drug Basic Information - Drug Name: Injectable Phosphor-Rolapitant Palonosetron - Dosage Form: Injectable - Acceptance Number: CXHS2600019 - Application Stage: Marketing - Applicant: Fujian Shengdi Pharmaceutical Co., Ltd. - Indication: Prevention of acute and delayed nausea and vomiting induced by moderately emetogenic anticancer drugs in adult patients [1]. Clinical Trial Information - The application for the new indication is based on a Phase III clinical trial (HR20013-302) evaluating the efficacy and safety of the drug. The trial was led by Sun Yat-sen University Cancer Center and involved 96 clinical research centers across the country, enrolling 706 participants [2]. - The primary and key secondary endpoints were the proportion of patients achieving complete response during the delayed and overall phases after administration of moderately emetogenic anticancer drugs. Results showed that the trial group had significantly higher complete response rates compared to the control group, with consistent advantages in symptom control, quality of life improvement, and time to treatment failure [2]. Other Drug Information - Nausea and vomiting induced by anticancer drugs are common adverse reactions in cancer treatment, potentially leading to dehydration, electrolyte imbalance, nutritional deficiencies, and esophageal mucosal tears, significantly affecting patients' quality of life and treatment adherence [3]. - Current guidelines recommend using NK1 receptor antagonists and 5-HT3 receptor antagonists in combination for preventing nausea and vomiting from highly emetogenic chemotherapy, while a dual regimen is suggested for moderately emetogenic drugs. However, adherence to these guidelines is often suboptimal due to various clinical factors [3]. Drug Characteristics - Injectable Phosphor-Rolapitant Palonosetron is a combination formulation that activates both NK-1 and 5-HT3 receptors to inhibit the vomiting reflex. It has a long half-life and high central nervous system penetration, providing advantages in preventing delayed and ultra-delayed vomiting [4]. - The product was approved for marketing in May 2025 for preventing acute and delayed nausea and vomiting caused by highly emetogenic chemotherapy in adults. Similar products available internationally include Helsinn Healthcare's AKYNZEO [4]. Research and Development Investment - Cumulative R&D investment for Injectable Phosphor-Rolapitant Palonosetron is approximately 247 million yuan (unaudited) [5].

Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for its drug application, indicating progress in the drug approval process [1] Group 1: Drug Information - The drug in question is Phosphorapitant Palonosetron Injection (HR20013) [1] - The dosage form is an injection [1] - The acceptance number for the application is CXHS2600019 [1] - The application is currently in the listing phase [1] Group 2: Indication - The proposed indication for the drug is to prevent acute and delayed nausea and vomiting in adult patients caused by moderately emetogenic anticancer drugs [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for the marketing authorization application of injectable fosnetupitant palonosetron, which is intended for the prevention of acute and delayed nausea and vomiting induced by moderately emetogenic anticancer chemotherapy in adult patients [1] Group 1 - The drug is a compound formulation that can simultaneously activate NK-1 and 5-HT3 receptors to inhibit the vomiting reflex [1] - Currently, there are no similar injectable products approved for marketing in China [1] - The total research and development investment for this project is approximately 247 million yuan [1]

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].