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恆瑞醫藥(01276.HK)獲得HRS-5041片臨牀試驗批準通知書

格隆匯7月31日丨恆瑞醫藥(01276.HK)公告,近日,江蘇恆瑞醫藥股份有限公司(以下簡稱“公司”)及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-5041片的《藥物臨牀試驗批準通知書》,將於近期開展臨牀試驗。

HRS-5041是公司開發的新型、高效、選擇性的AR-PROTAC(雄激素受體-蛋白降解靶向嵌合體)小分子,擬用於治療前列腺癌。HRS-5041對野生型及各類突變體的AR蛋白有顯著的降解作用,與二代AR抑制劑相比,有克服耐藥的潛力。經查詢,目前國內外暫無同類產品獲批上市。截至目前,HRS-5041片相關項目累計研發投入約6,919萬元。

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