萊美藥業(300006.SZ):注射用甲潑尼龍琥珀酸鈉(40mg)通過仿製藥一致性評價
格隆匯2月22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化學藥品注射用甲潑尼龍琥珀酸鈉(規格:40mg)的《藥品補充申請批准通知書》。
注射用甲潑尼龍琥珀酸鈉是一種人工合成的糖皮質激素,主要用於抗炎治療(如風濕性疾病、膠原疾病、皮膚疾病等)、免疫抑制治療(器官移植)、血液疾病(獲得性溶血性貧血、成人自發性血小板減少性紫癜、成人繼髮型血小板減少等)、腫瘤(成人白血病和淋巴瘤、兒童急性白血病的姑息治療)、休克治療、內分泌失調。甲潑尼龍琥珀酸鈉極易溶於水,供靜脈或肌肉注射用,在血漿中迅速水解,以遊離甲潑尼龍的形式發揮藥理作用。與潑尼松龍相比,除了具有糖皮質激素的藥理作用外,有更強的抗炎作用和較弱的水、鈉瀦留作用。
萊美藥業現有的產品注射用甲潑尼龍琥珀酸鈉規格為125mg和40mg,分別於2020年6月和2020年7月取得國家藥品監督管理局核准簽發的《藥品註冊證書》,注射用甲潑尼龍琥珀酸鈉於2020年12月被納入《醫保目錄》,公司於2020年11月向國家藥品監督管理局藥品審評中心提交注射用甲潑尼龍琥珀酸鈉(規格:40mg)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。
根據米內網全國放大版的醫院數據(城市公立醫院)顯示,注射用甲潑尼龍琥珀酸鈉在2019年、2020年、2021年上半年的銷售額分別約為12.22億元、10.31億元、5.38億元,包含20mg、40mg、125mg、250mg、500mg等規格,其中佔市場主導的規格為40mg,注射用甲潑尼龍琥珀酸鈉(規格:40mg)在2019年、2020年、2021年上半年的銷售額分別約為9.69億元、7.99億元、4.09億元。
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