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恆瑞醫藥(01276.HK)旗下HRS-3095片獲批開展臨牀試驗 用於治療慢性自發性蕁麻疹(CSU)

格隆匯9月23日丨恆瑞醫藥(01276.HK)公佈,近日,公司子公司成都盛迪醫藥有限公司收到國家藥品監督管理局(以下簡稱"國家藥監局")覈準簽發關於HRS-3095 片的《藥物臨牀試驗批準通知書》,將於近期開展臨牀試驗。

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2025年 7 月 7 日受理的 HRS-3095 片臨牀試驗申請符合藥品註冊的有關要求,同意本品開展臨牀試驗。申請的適應症爲用於慢性自發性蕁麻疹(CSU)患者。

據悉,HRS-3095 片是公司自主研發的靶向免疫細胞的小分子化合物,對過敏性疾病起到良好的治療效果。臨牀前數據顯示,HRS-3095 可有效改善小鼠的皮膚過敏症狀。經查詢,針對 CSU 適應症,目前國內外暫無同靶點藥物獲批上市。截至目前,HRS-3095 片相關項目累計研發投入約 1,603 萬元。

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