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再鼎醫藥-SB(09688.HK):則樂®(尼拉帕利)一線維持治療卵巢癌被納入中國國家醫保藥品目錄
格隆匯 12-03 20:58

2021年12月3日—再鼎醫藥有限公司(納斯達克股票代碼:ZLAB;香港聯交所股票代碼:9688),一家以患者為中心的、處於商業化階段的創新型全球生物製藥公司,今日宣佈則樂(尼拉帕利)已被納入中國國家醫療保障局(國家醫保局)最新發布的國家醫保藥品目錄,用於晚期上皮性卵巢癌、輸卵管癌或原發性腹膜癌(統稱為卵巢癌)成人患者對含鉑化療產生應答後的一線維持治療,無論生物標記物狀態如何。

再鼎醫藥創始人、董事長兼首席執行官杜瑩博士表示:"將變革性的創新藥物帶給中國患者是我們的重要使命之一,則樂®一線維持治療卵巢癌被納入國家醫保藥品目錄使我們朝着這一使命又邁進了一步。非常感謝國家醫保局,這將進一步提升中國卵巢癌患者對則樂®的可及性。"

再鼎醫藥首席商務官梁怡表示:"國家醫保報銷能夠提升中國卵巢癌患者對則樂的可及性。則樂®是唯一獲批的無論患者生物標記物狀態如何,均能單藥用於一線和復發卵巢癌維持治療的PARP抑制劑。此次則樂®被納入國家醫保藥品目錄也凸顯了則樂®對於廣大卵巢癌患者的臨牀價值。"

於2021年11月,再鼎醫藥宣佈則樂®作為維持治療的3期臨牀研究PRIME達到了主要研究終點,證實了對於新診斷的中國晚期卵巢癌患者,無論生物標記物狀態如何,在接受含鉑化療產生應答後,則樂作為維持治療可使無進展生存期(PFS)在統計學和臨牀意義上均得到顯着的獲益,且安全性可管理。

於2020年12月,則樂被納入國家醫保藥品目錄,用於鉑敏感複發性卵巢癌成人患者的維持治療。

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