恒瑞醫藥(600276.SH):HRS9531注射液獲批開展減重適應症的Ⅱ期臨牀試驗
格隆匯5月7日丨恒瑞醫藥(600276.SH)公佈,近日,公司子公司福建盛迪醫藥有限公司收到國家藥品監督管理局(“國家藥監局”)核准簽發關於HRS9531注射液的《藥物臨牀試驗批准通知書》,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,2023年1月10日受理的HRS9531注射液符合藥品註冊的有關要求,同意按照提交的方案開展減重適應症的Ⅱ期臨牀試驗。
HRS9531注射液為公司自主研製的靶向GIP和GLP-1的受體激動劑。同靶點藥物中禮來的Tirzeptide已於2022年5月在美國獲批上市(商品名:Mounjaro),用於治療2型糖尿病。此外,Tirzeptide用於肥胖患者的兩項Ⅲ期臨牀研究已取得成功,並獲得FDA快速通道資格。經查詢EvaluatePharma數據庫,2022年Tirzeptide全球銷售額合計約4.83億美元。截至目前,HRS9531相關研發項目累計已投入研發費用約6225萬元。
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