濟川藥業(600566.SH)子公司獲左乙拉西坦注射用濃溶液(500mg/5ml)藥品註冊批件
格隆匯1月13日丨濟川藥業(600566.SH)公佈,近日,公司下屬子公司濟川藥業集團有限公司(“濟川有限”)收到國家藥品監督管理局核准簽發的左乙拉西坦注射用濃溶液(5mL:500mg)《藥品註冊批件》。
左乙拉西坦(KEPPRA®)由比利時UCB公司研發,其左乙拉西坦注射用濃溶液(500mg/5mL)於2006年7月獲得FDA批准上市,國內批准上市時間為2017年7月。
左乙拉西坦是一種吡咯烷酮衍生物,其抗癲癇作用機制主要和腦內的特殊受體--突觸囊泡蛋白SV2A結合,具有中樞選擇性,通過參與囊泡的聚合與胞吐作用調節神經遞質釋放而發揮作用。
適應症:成人及4歲以上兒童癲癇患者部分性發作(伴或不伴繼發性全面性發作)的加用治療。在患者暫時無法應用左乙拉西坦口服制劑時,可替代使用。公司該藥品首次提交註冊申請獲得受理的時間為2017年5月25日。截至目前,該藥品累計研發支出共計3,355萬元(未經審計)。藥物目前的審批階段為批准生產。
本品藥品註冊分類為化學藥品3類。根據國家藥監局《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)文件相關規定,本品視為通過仿製藥質量和療效一致性評價。
截止目前,左乙拉西坦注射用濃溶液國內批文3件(含濟川有限),進口批文1件。根據米內網數據顯示,2018年全國城市公立醫院抗癲癇藥銷售總額約40.78億元,其中,左乙拉西坦通用名產品以9.57億元的銷售額位列第二。
左乙拉西坦注射用濃溶液在國內上市時間較晚,尚未形成規模銷售。根據米內網統計的全國城市公立醫院銷售數據,左乙拉西坦注射用濃溶液2018年銷售金額為49萬元。
此次公司獲得左乙拉西坦注射用濃溶液(500mg/5ml)的《藥品註冊批件》,是對公司產品的進一步補充,豐富了公司產品線。
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