萊美藥業(300006.SZ):注射用磷酸氟達拉濱通過一致性評價
格隆匯9月14日丨萊美藥業(300006.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的規格為50mg化學藥品注射用磷酸氟達拉濱的《藥品補充申請批准通知書》。經審查,該藥品通過仿製藥質量和療效一致性評價。
注射用磷酸氟達拉濱為抗病毒藥Vidarabine的氟化核苷相似物,具有Ara-C相似的抗腫瘤作用機制,但不被腺苷脱氨酶脱氨滅活。攝入後迅速經去磷酸作用生成2-氟阿糖腺苷(F-Ara-A),後者在細胞內經磷酸化變成有抗瘤活性的F-Ara-ATP。它可抑DNA多聚酶、DNA引物酶(Primase)、DNA螺旋酶和核苷酸還原酶,還可摻入腫瘤細胞DNA和RNA鏈,使鏈停止延伸,抑制DNA和RNA的合成。
注射用磷酸氟達拉濱已被納入《醫保目錄》。公司現有的產品注射用磷酸氟達拉濱規格為50mg,於2005年12月取得國家藥品監督管理局核准簽發的《藥品註冊證書》。公司於2021年9月向國家藥品監督管理局藥品審評中心提交一致性評價申請並獲受理,近日,該藥品通過仿製藥質量和療效一致性評價。
注射用磷酸氟達拉濱由先靈葆雅公司Schering(現更名為“Bayer”)研發,臨牀上主要用於B細胞性慢性淋巴細胞白血病患者的治療,最早於1991年在美國由FDA獲批上市,由美國健贊公司Genzyme和賽諾菲公司Sanofi共同銷售。2001年,注射用磷酸氟達拉濱在我國獲得進口批准。
根據米內網全國放大版的醫院數據(城市公立醫院)顯示,注射用磷酸氟達拉濱2019年、2020年、2021年的銷售額分別約為1.16億元、1.14億元、1.11億元。
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