昆藥集團(600422.SH):公司獲鹽酸法舒地爾注射液藥品註冊證書
格隆匯12月21日丨昆藥集團(600422.SH)公佈,近日,公司收到國家藥品監督管理局簽發的關於鹽酸法舒地爾注射液的《藥品註冊證書》。
鹽酸法舒地爾及其注射液由日本旭化成株式會社(以下簡稱“旭化成”)和名古屋大學聯合開發,1995年在日本上市,2001年在中國上市,主要用於蛛網膜下腔出血後腦血管痙攣等引起的缺血性腦血管疾病症狀的改善。
鹽酸法舒地爾注射液為國家醫保目錄乙類品種,根據藥智網醫院銷售數據庫顯示,2017-2019年,鹽酸法舒地爾注射液年銷售額約人民幣3-4億元。目前,中國境內有包括原研日本旭化成株式會社、天津紅日藥業股份有限公司、山西普德藥業有限公司等企業的產品獲批上市及銷售。
該藥品的原料藥為公司自產,公司已於2020年1月獲得國家藥品監督管理局藥品審評中心(CDE)登記備案批准生產;截至本公告日,公司針對鹽酸法舒地爾原料藥和注射液的生產註冊已投入研發費用約人民幣1250.03萬元。
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