恆瑞醫藥(600276.SH)：氟唑帕利膠囊及醋酸阿比特龍片(Ⅰ)獲批臨牀試驗
格隆匯3月16日丨恆瑞醫藥(600276.SH)公佈，公司及子公司成都盛迪醫藥有限公司近日收到國家藥監局核准簽發的關於氟唑帕利膠囊及醋酸阿比特龍片(Ⅰ)的《藥物臨牀試驗批准通知書》，並將於近期開展臨牀試驗。
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，2020年Olaparib(商品名Lynparza)、Rucaparib(商品名Rubraca)和Niraparib(商品名Zejula)全球銷售額約為24.21億美元。截至目前，氟唑帕利相關項目累計已投入研發費用約為32,124萬元。
阿比特龍片最早由Janssen-Cilag International N.V.公司開發，商品名為Zytiga®，於2011年4月在美國獲批上市，目前已在加拿大、歐盟、日本等多個國家上市銷售。2015年，Janssen-Cilag International N.V.公司開發的阿比特龍片在中國獲批，商品名為澤珂®。經查詢Evaluate Pharma數據，2019年醋酸阿比特龍片銷售額為28.89億美元。截至目前，醋酸阿比特龍片(I)相關項目累計已投入研發費用約1429萬元。
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