濟川藥業(600566.SH):硫酸鎂鈉鉀口服用濃溶液獲批上市
格隆匯2月10日丨濟川藥業(600566.SH)公佈,近日,公司下屬全資子公司濟川藥業集團有限公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的硫酸鎂鈉鉀口服用濃溶液《藥品註冊證書》。
硫酸鎂鈉鉀口服用濃溶液由美國Braintree Laboratories公司研發,2010年8月5日獲FDA批准上市,商品名為 SUPREP® Bowl Prep Kit,規格為每瓶6盎司(約177ml),包括硫酸鈉17.5g、硫酸鉀3.13g和硫酸鎂1.6g。該品適用於成人,用於任何需要清潔腸道的操作前的腸道清潔。
公司該產品首次提交註冊申請獲得受理的時間為2020年6月12日。截至目前,該藥品累計研發支出約2800萬元(未經審計),均已費用化。
該產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吿》(2017年第100號)文件相關規定,上市後視同通過一致性評價。
截止目前,公司硫酸鎂鈉鉀口服用濃溶液為國內首仿上市。除公司外,目前暫無其他廠家在中國大陸獲批上市。
硫酸鎂鈉鉀口服用濃溶液作為一種新型腸道清潔準備劑,具有服用量小、患者耐受性高、腸道清潔效果好的特點,是歐洲及美國腸道清潔準備指南的推薦用藥。該藥不僅適用於腸鏡檢查前的腸道清潔準備,還可用於外科手術、放射檢查前的腸道清潔準備。
米內網數據顯示,2020年全國城市公立醫院腸道清潔準備相關的藥物合計銷售額超過10億元。目前國內臨牀常用的腸道清潔準備藥物包括複方聚乙二醇電解質散、磷酸鈉鹽口服溶液等。
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