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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]