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恆瑞醫藥(600276.SH)海曲泊帕乙醇胺片獲批臨牀
格隆匯 08-21 18:25

格隆匯8月21日丨恆瑞醫藥(600276.SH)宣佈,公司及子公司上海恆瑞醫藥有限公司近日收到國家藥監局核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。藥品名稱:海曲泊帕乙醇胺片;劑型:片劑;規格:5mg;申請事項:臨牀試驗;受理號:CXHL1900191。

2011年2月12日,公司向江蘇省食品藥品監督管理局遞交本品臨牀試驗申請首次獲受理。本品系口服吸收的小分子非肽類促血小板生成素受體(TPO-R)激動劑,本次臨牀試驗申請用於腫瘤化療所致血小板減少症(CIT)適應症。

同類產品艾曲泊帕(Eltrombopag,PROMACTA®)是葛蘭素史克公司研發的非肽類TPO-R激動劑,最早於2008年獲美國FDA批准上市,目前該品種已在全球100多個國家批准上市。2018年7月21日,諾華中國宣佈艾曲泊帕在中國獲批上市,商品名為瑞弗蘭®,用於特發性血小板減少性紫癜(ITP)患者。為了尋找更加高效、低毒的TPO-R激動劑,公司對艾曲泊帕進行了一系列結構的修飾,研究開發具有自主知識產權的1類創新藥:高選擇性TPO-R激動劑海曲泊帕乙醇胺片。

經查詢 IMS數據庫,2018年艾曲泊帕全球總銷售額約為10.2650億美元,國內銷售額約為277萬美元。

截至目前,該產品項目已投入研發費用約為9209萬元人民幣。

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