四環醫藥(00460.HK):周圍神經病變藥物甲鈷胺片獲國家藥監局上市批准
格隆匯6月1日丨四環醫藥(00460.HK)發佈公吿,集團旗下非全資附屬公司惠升生物製藥股份有限公司(“惠升生物”)研發的周圍神經病變藥物甲鈷胺片(規格:0.5毫克)獲得國家藥品監督管理局頒發的藥品註冊批件,視同通過仿製藥質量和療效一致性評價。甲鈷胺片是惠升生物首個獲批上市的藥物,同時,也是惠升生物首個獲批上市的抗糖尿病併發症藥物,標誌着惠升生物的抗糖尿病併發症藥物將從研發步入商業化發展的新里程。
甲鈷胺是一種內源性輔酶B12,可以不經過肝臟代謝,也不需要進行生物轉化,可直接發揮活性作用,臨牀上常用於各類周圍神經病的治療,如神經痛、面癱、神經炎、神經障礙等,也可用於治療糖尿病周圍神經病變(DiabeticPeripheralNeuropathy,DPN),《糖尿病周圍神經病診斷和治療共識》推薦甲鈷胺用於治療DPN神經營養修復。
糖尿病周圍神經病變在糖尿病患者中發病率高達60%以上,屬於一種常見的糖尿病慢性併發症,據IDF最新報吿,中國2021年約1.4億糖尿病患者,據此計算,我國約有8400萬糖尿病周圍神經病變患者。甲鈷胺片屬於國家醫保乙類品種(2022版)。根據IMS數據顯示,甲鈷胺片2022年國內樣品醫院採購金額超人民幣十億元,隨着糖尿病治療市場的增長,甲鈷胺有望進一步放量。
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