恆瑞醫藥(600276.SH):氟唑帕利膠囊擬納入優先審評程序
格隆匯1月8日丨恆瑞醫藥(600276.SH)公佈,公司開發的氟唑帕利膠囊近日被國家藥品監督管理局藥品審評中心納入擬優先審評品種公示名單,公示期7日。
氟唑帕利為恆瑞醫藥研發的新型PARP抑制劑,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。
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。
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