天士力(600535.SH):卡託普利片通過仿製藥一致性評價
格隆匯 11 月 9日丨天士力(600535.SH)公佈,近日,公司之全資子公司江蘇天士力帝益藥業有限公司(“江蘇帝益”)收到國家藥品監督管理局頒發的關於卡託普利片25mg規格的《藥品補充申請批準通知書》(通知書編號:2020B04889),該藥品通過仿製藥一致性評價。
卡託普利片主要用於治療高血壓和心力衰竭,為國家基本藥物,並進入國家醫保目錄(甲類)。該藥品於2019年6月28日向國家藥監局遞交一致性評價申請,於2019年7月5日獲得受理。
目前,中國境內該藥品的主要生產廠家有常州製藥、石藥歐意藥業、上海旭東海普藥業、羅欣藥業等。根據米內數據庫,卡託普利片2019年的城市公立醫院年度銷售額為1986萬元。截至公告日,江蘇帝益針對該藥品一致性評價已投入研發費用約為516.92萬元人民幣。
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