方盛製藥(603998.SH):“依折麥布片”國產藥品註冊申請處於待制證狀態
格隆匯9月11日丨方盛製藥(603998.SH)宣佈,近日,經查詢國家藥監局網站獲悉:公司向國家藥監局提交的“依折麥布片”國產藥品註冊申請處於“審批完畢-待制證”狀態,藥品批准文號為:國藥準字H20203468。
依折麥布片由默沙東公司研發,商品名為Ezetimibe Tablets。依折麥布片是全球首個膽固醇吸收抑制劑,它能通過選擇性抑制小腸膽固醇運轉蛋白,有效減少腸道內膽固醇吸收,降低血漿膽固醇水平以及肝臟膽固醇儲量,臨牀上主要用於治療原發性高膽固醇血癥。依折麥布2007年全球銷售額首次突破20億美元,隨着專利到期,該產品銷售額出現下降,2019年全球銷售額為5.9億美元。
依折麥布片為公司獲得的首個用於治療高膽固醇血癥的用藥,對公司藥品種類及市場開拓方面的具有重要意義。根據《關於開展仿製藥質量和療效一致性評價的意見》(國辦發〔2016〕8號)的相關規定,公司該次獲批的依折麥布片無需再進行一致性評價。
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