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恒瑞医药旗下HRS-3095片获批开展临床试验 用于治疗慢性自发性荨麻疹(CSU)
Ge Long Hui·2025-09-23 09:49

Core Viewpoint - Heng Rui Medicine's subsidiary Chengdu Shengdi Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of HRS-3095 tablets, aimed at treating chronic spontaneous urticaria (CSU) [1] Group 1: Clinical Trial Approval - The clinical trial application for HRS-3095 tablets was accepted on July 7, 2025, and has met the requirements for drug registration [1] - The drug is designed for patients suffering from chronic spontaneous urticaria (CSU) [1] Group 2: Drug Development - HRS-3095 tablets are a self-developed small molecule compound targeting immune cells, showing promising therapeutic effects for allergic diseases [1] - Preclinical data indicates that HRS-3095 can effectively improve skin allergy symptoms in mice [1] - Currently, there are no approved drugs targeting the same mechanism for CSU in both domestic and international markets [1] Group 3: Research Investment - The total research and development investment for the HRS-3095 project has reached approximately 16.03 million yuan [1]