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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
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]
恒瑞医药(600276.SH):硫酸艾玛昔替尼片、SHR0302碱凝胶获批临床试验
智通财经网· 2025-11-27 09:21
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, aimed at treating vitiligo [1] Group 1 - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., will soon initiate clinical trials for the approved drugs [1] - The indications for the drugs include the use of Sulfate Emamectin Benzoate Tablets alone or in combination with SHR0302 Gel for the treatment of vitiligo [1]
恒瑞医药:硫酸艾玛昔替尼片、SHR0302碱凝胶获批临床试验
Zhi Tong Cai Jing· 2025-11-27 09:18
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, aimed at treating vitiligo [1] Group 1 - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., will soon initiate clinical trials for the approved drugs [1] - The indications for the drugs include the use of Sulfate Emamectin Benzoate Tablets alone or in combination with SHR0302 Gel for the treatment of vitiligo [1]
恒瑞医药:硫酸艾玛昔替尼片等两款产品临床试验获批
Xin Lang Cai Jing· 2025-11-27 09:12
Core Viewpoint - Heng Rui Medicine announced the approval of clinical trial notifications for Sulfate Emamectin Benzoate Tablets and SHR0302 Gel by the National Medical Products Administration, aimed at treating vitiligo [1] Group 1 - The company and its subsidiary, Ruishi Biopharmaceutical Co., Ltd., received approval for clinical trials [1] - The approved indications include the use of Sulfate Emamectin Benzoate Tablets alone or in combination with SHR0302 Gel for the treatment of vitiligo [1]