恆瑞醫藥(600276.SH)：氟唑帕利膠囊獲《藥品註冊證書》
格隆匯12月17日丨恆瑞醫藥(600276.SH)公佈，公司近日收到國家藥品監督管理局核准簽發的關於氟唑帕利膠囊的《藥品註冊證書》。
氟唑帕利膠囊本次獲批的適應症為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。本次新藥上市申請於2019年獲得國家藥品監督管理局受理，並被國家藥品監督管理局藥品審評中心納入優先審評。本次上市申請基於一項“氟唑帕利治療BRCA1/2突變的複發性卵巢癌的單臂、多中心Ⅰb期臨牀研究”獲得批准。
氟唑帕利單藥用於複發性卵巢癌(包括輸卵管癌、原發性腹膜癌)含鉑治療達到完全緩解或部分緩解後的維持治療，可顯著延長患者的無進展生存期。氟唑帕利單藥或聯合阿帕替尼治療卵巢癌、乳腺癌、胰腺癌已處於III期臨牀研究階段。氟唑帕利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及替莫唑胺聯合治療多種實體腫瘤已處於臨牀開發階段。
氟唑帕利是一種聚腺苷二磷酸核糖聚合酶(poly(ADP-ribose)polymerase,PARP)抑制劑，可特異性殺傷BRCA突變的腫瘤細胞。經查詢，氟唑帕利目前國外有同類產品Olaparib(商品名Lynparza)、Rucaparib(商品名Rubraca)、Niraparib(商品名Zejula)和Talazoparib(商品名Talzenna)於美國獲批上市銷售，Olaparib(商品名Lynparza)於2018年8月在中國獲批上市，商品名為利普卓。國內再鼎醫藥的甲苯磺酸尼拉帕利膠囊(商品名則樂)於2019年12月在中國獲批上市，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成人患者在含鉑化療達到完全緩解或部分緩解後的維持治療。經查詢，2019年Olaparib(商品名Lynparza)、Rucaparib(商品名Rubraca)、Niraparib(商品名Zejula)和Talazoparib(商品名Talzenna)全球銷售額約為13.57億美元，美國銷售額約為6.74億美元。截至目前，該產品累計已投入研發費用約為2.95億元。
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