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恆瑞醫藥(600276.SH):氟唑帕利膠囊獲美國FDA國際多中心臨牀試驗資格
格隆匯 02-22 17:03

格隆匯2月22日丨恆瑞醫藥(600276.SH)公佈,公司已於美國時間2021年1月21日向美國食品藥品監督管理局提交了氟唑帕利膠囊國際多中心臨牀試驗申請並獲受理。按照美國藥品註冊相關法律法規的規定,美國FDA自受理之日起30日內未下發“暫停臨牀試驗”或“暫停部分臨牀試驗”通知的,即視為獲准進行臨牀試驗。日前,公司已獲得美國FDA國際多中心臨牀試驗資格,並將於近期開展相關臨牀試驗。

公司的氟唑帕利膠囊已於2020年12月11日獲得國家藥品監督管理局批准用於既往經過二線及以上化療的伴有胚系BRCA突變(gBRCAm)的鉑敏感複發性卵巢癌、輸卵管癌或原發性腹膜癌患者的治療。2021年1月,本品用於鉑敏感的複發性上皮性卵巢癌、輸卵管癌或原發性腹膜癌在含鉑化療達到完全緩解或部分緩解後的維持治療已被國家藥品監督管理局藥品審評中心納入優先審評。

除用於鉑敏感的複發性卵巢癌、輸卵管癌或原發性腹膜癌治療外,氟唑帕利膠囊單藥或聯合甲磺酸阿帕替尼片的多個適應症開發已處在III期臨牀研究階段,另有多種聯合治療方案,包括與阿比特龍聯合、與抗PD-L1抗體SHR-1316聯合、以及與替莫唑胺聯合治療多種實體腫瘤已處於臨牀開發階段。截至目前,氟唑帕利相關項目累計已投入研發費用約為3.14億元。

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