硫酸艾玛昔替尼片
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恒瑞医药:公司自主研发的1类创新药硫酸艾玛昔替尼片已在国内获批,用于成人重度斑秃患者
Zheng Quan Ri Bao Wang· 2026-02-13 13:13
证券日报网讯2月13日,恒瑞医药(600276)在互动平台回答投资者提问时表示,公司坚持科技创新与 国际化发展战略,促进公司业绩可持续增长,以更好的发展回馈股东。公司自主研发的1类创新药硫酸 艾玛昔替尼片已在国内获批,用于成人重度斑秃患者。 ...
江苏恒瑞医药股份有限公司 关于公司药品纳入国家医保目录的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-07 22:40
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]
江苏恒瑞医药股份有限公司关于公司药品纳入国家医保目录的公告
Shang Hai Zheng Quan Bao· 2025-12-07 18:39
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].
恒瑞医药多款药品被纳入2025年国家医保目录
Ge Long Hui· 2025-12-07 08:32
Core Viewpoint - Heng Rui Medicine has successfully included several of its products in the National Medical Insurance Directory, which is expected to enhance sales and potentially improve the company's operational performance, although the exact impact remains uncertain [1][2]. Group 1: Inclusion in National Medical Insurance Directory - Heng Rui Medicine's products such as injection of Rukang Qutuzumab and others have been included in the National Medical Insurance Directory for 2025 [1]. - New indications for existing products like injection of Karilizumab and others have also been successfully added to the directory [1]. - Some products have retained their status in the directory, while others have had their indications adjusted to regular management [1]. Group 2: Financial Impact - The total sales for the aforementioned products are estimated to be approximately 8.66 billion yuan for 2024 and about 7.55 billion yuan for the first three quarters of 2025 [2]. - The implementation of the National Medical Insurance Directory will officially begin on January 1, 2026, with further details on payment standards and reimbursement to be announced by relevant government departments [2].
恒瑞医药10款新药首次纳入2025医保目录
Xin Lang Ke Ji· 2025-12-07 06:34
Core Viewpoint - Heng Rui Medicine has successfully included 10 new products in the 2025 National Medical Insurance Drug List, marking a significant milestone for the company in expanding its market presence in various therapeutic areas [1] Group 1: New Drug Inclusion - Heng Rui Medicine's 10 products cover multiple fields including oncology, metabolism, cardiovascular diseases, immune system diseases, and ophthalmology [1] - The specific drugs included are: - Injection of Rukang Qutuzumab - Sulfate of Amaglimin Tablets - Injection of Funachizumab - Injection of Rikasimab - Injection of Phosphororapitan Palonosetron - Regaglitin Metformin Tablets (I)/(II) - Famitin Acid Capsules - Acetate of Abiraterone Tablets (II) - Lipid Injection of Irinotecan Hydrochloride (II) - Perfluorohexyl Octane Eye Drops [1]
恒瑞医药(01276.HK):硫酸艾玛昔替尼片、SHR0302碱凝胶获同意开展临床试验
Ge Long Hui· 2025-11-27 09:49
Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, aimed at treating vitiligo [1] Group 1: Company Developments - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have been granted the Clinical Trial Approval Notice for the mentioned drugs [1] - The clinical trial applications for Sulfate Emamectin Benzoate Tablets and SHR0302 Gel were accepted on August 29, 2025, and have met the requirements for drug registration [1] Group 2: Product Information - The intended use for Sulfate Emamectin Benzoate Tablets is as a monotherapy or in combination with SHR0302 Gel for the treatment of vitiligo [1]
恒瑞医药(01276):硫酸艾玛昔替尼片、SHR0302碱凝胶获得《药物临床试验批准通知书》
智通财经网· 2025-11-27 09:45
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, indicating progress in its drug development pipeline [1] Group 1: Drug Approvals and Clinical Trials - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have been granted a clinical trial approval notice for Sulfate Emamectin Benzoate Tablets and SHR0302 Gel [1] - Sulfate Emamectin Benzoate Tablets have already been approved for four indications in China, including treatment for adult patients with active ankylosing spondylitis and moderate to severe rheumatoid arthritis who have had inadequate response to TNF inhibitors [1] Group 2: Drug Mechanism and Market Context - Sulfate Emamectin Benzoate is a highly selective JAK1 inhibitor that exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [1] - Currently, there are no oral drugs of the same class approved globally for the treatment of vitiligo, although a topical drug, Ruxolitinib cream (OPZELURA®), has been approved, with no sales data available [1] Group 3: Research and Development Investment - The cumulative R&D investment for Sulfate Emamectin Benzoate projects has reached approximately 1.091 billion yuan [1]
恒瑞医药:硫酸艾玛昔替尼片、SHR0302碱凝胶获得《药物临床试验批准通知书》
Zhi Tong Cai Jing· 2025-11-27 09:43
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin and SHR0302 gel, indicating a significant advancement in its product pipeline [1] Group 1: Clinical Trial Approvals - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have been granted the Clinical Trial Approval Notice for Sulfate Emamectin Tablets and SHR0302 gel [1] - Sulfate Emamectin Tablets have already been approved for four indications in China, including active ankylosing spondylitis and moderate to severe active rheumatoid arthritis [1] Group 2: Product Details - Sulfate Emamectin is a highly selective JAK1 inhibitor that exerts anti-inflammatory and immunosuppressive effects by inhibiting JAK1 signaling [1] - Currently, there are no oral counterparts approved globally for the treatment of vitiligo, although a topical drug, Ruxolitinib cream (OPZELURA), has been approved [1] Group 3: Research and Development Investment - The cumulative R&D investment related to Sulfate Emamectin has reached approximately 1.091 billion yuan [1]
恒瑞医药:公司及子公司收到药物临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-11-27 09:22
Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, indicating progress in its drug development pipeline [1] Group 1: Company Developments - Heng Rui Medicine and its subsidiary, Ruishi Bio, have been granted the Clinical Trial Approval Notice for Sulfate Emamectin Benzoate Tablets and SHR0302 Gel [1] - Sulfate Emamectin Benzoate Tablets have already been approved for four indications in China, showcasing the company's existing market presence [1] - Sulfate Emamectin Benzoate is identified as a highly selective JAK1 inhibitor, which may position the company favorably in the competitive pharmaceutical landscape [1] Group 2: Regulatory Environment - The approval for clinical trials is a prerequisite for conducting further clinical studies and obtaining production and marketing approval from the National Medical Products Administration [1] - The company must adhere to the relevant laws and regulations regarding drug registration in China, which emphasizes the importance of regulatory compliance in the pharmaceutical industry [1]
恒瑞医药:硫酸艾玛昔替尼片等多款药物临床试验获批
Zheng Quan Shi Bao Wang· 2025-11-27 09:22
Core Viewpoint - Heng Rui Medicine (600276) has received approval from the National Medical Products Administration for multiple clinical trial applications, indicating a significant advancement in its drug development pipeline [1] Group 1: Clinical Trial Approvals - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., have received approval for clinical trials of Sulfate Emamectin Benzoate Tablets and SHR0302 Gel, which will commence shortly [1] - Additionally, the company and its subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Heng Rui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have been granted approval for clinical trials of several products, including HRS-7058 Capsules, HRS-7058 Tablets, SHR-9839(sc), Adebali Injection, Bevacizumab Injection, and SHR-A2102 Injection, with trials set to begin soon [1]