恆瑞醫藥(600276.SH)：收到氟唑帕利膠囊、貝伐珠單抗注射液的藥物臨牀試驗批准通知書
格隆匯9月28日丨恆瑞醫藥(600276.SH)公佈，近日，公司及子公司蘇州盛迪亞生物醫藥有限公司收到國家藥品監督管理局核准簽發關於氟唑帕利膠囊、貝伐珠單抗注射液的《藥物臨牀試驗批准通知書》，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，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；國內再鼎醫藥的甲苯磺酸尼拉帕利膠囊(商品名則樂)、百濟神州的帕米帕利膠囊(商品名百匯澤)已獲批上市，Olaparib已在國內上市。2020年Olaparib(商品名Lynparza)、Rucaparib(商品名Rubraca)和Niraparib(商品名Zejula)全球銷售額合計約為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4.53億元。
貝伐珠單抗是一種人源化抗VEGF單克隆抗體，由中外製藥和羅氏的子公司基因泰克合作開發，最早2004年由美國食品藥品監督管理局批准上市，商品名為Avastin(安維汀)，目前已在中國和全球多個國家上市銷售。除安維汀及艾瑞妥外，國內目前有3個貝伐珠單抗注射液獲批上市，分別為齊魯製藥的安可達、信達生物的達攸同和山東博安生物的博優諾。同時，國內多家企業的同類產品已向國家藥品監督管理局遞交上市申請，目前狀態為“在審評審批中”，包括綠葉製藥、貝達藥業、百奧泰等。
經查詢EvaluatePharma數據庫，安維汀2020年全球銷售額約53.24億美元。截至目前，貝伐珠單抗相關項目累計已投入研發費用約為2.63億元。
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