Ruxolitinib乳膏(OPZELURA)
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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]