恆瑞醫藥(600276.SH)：海曲泊帕乙醇胺片獲美國FDA臨牀試驗資格 將於近期開展III期臨牀試驗
格隆匯1月11日丨恆瑞醫藥(600276.SH)公佈，近日，公司收到美國食品藥品監督管理局(“美國FDA”)關於同意海曲泊帕乙醇胺片進行臨牀試驗的函，將於近期開展III期臨牀試驗。
試驗通俗題目：海曲泊帕治療惡性腫瘤化療所致血小板減少症的III期臨牀研究試驗(方案編號：HR-TPO-CIT-301)。
海曲泊帕乙醇胺片於2017年12月獲得國家藥品監督管理局批准開展治療再生障礙性貧血的臨牀試驗(公吿編號：臨2017-080)，2019年8月獲批開展腫瘤化療所致血小板減少症(CIT)的臨牀試驗(公吿編號：臨2019-055)，2020年11月獲批在兒童和青少年慢性原發免疫性血小板減少症患者中開展III期臨牀試驗(公吿編號：臨2020-114)。
此次獲得美國FDA臨牀試驗資格後，海曲泊帕治療惡性腫瘤化療所致血小板減少症的臨牀研究計劃在美國、歐洲和澳洲開展。
海曲泊帕乙醇胺是一種口服非肽類血小板生成素受體(TPO-R)激動劑，通過激活TPO-R介導的STAT和MAPK信號轉導通路，促進血小板生成。經查詢，目前國外有海曲泊帕乙醇胺片同類產品Eltrombopag (葛蘭素史克，商品名Promacta)、 Avatrombopag (Dova Pharmaceuticals，商品名Doptelet)、Lusutrombopag (Shionogi，商品名 Mulpleta)獲批上市。在國內，Eltrombopag於2017年獲批上市，產品名稱為艾曲泊帕乙醇胺片，用於慢性免疫性(特發性)血小板減少症(ITP)成人患者，Avatrombopag於2020年獲批上市，產品名稱為馬來酸阿伐曲泊帕片，用於擇期行診斷性操作或者手術的慢性肝病相關血小板減少症的成年患者。經查詢EvaluatePharma數據庫，2020年 Promacta、Doptelet和Mulpleta全球銷售額約17.99億美元。截至目前，海曲泊帕乙醇胺片相關項目累計已投入研發費用約21310萬元。
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