上海醫藥(601607.SH):鹽酸克林黴素膠囊通過仿製藥一致性評價
格隆匯 9 月 14日丨上海醫藥(601607.SH)宣佈,近日,公司控股子公司上海新亞藥業閔行有限公司(以下簡稱“新亞閔行”)收到國家藥品監督管理局(以下簡稱“國家藥監局”)頒發的關於鹽酸克林黴素膠囊(以下簡稱“該藥品”)的《藥品補充申請批准通知書》(通知書編號:2020B04527),該藥品通過仿製藥一致性評價。
鹽酸克林黴素膠囊主要適用於敏感厭氧菌引起的嚴重感染,由Pharmacia&UpjohnCo.研發,最早於1970年在美國上市。2019年1月,新亞閔行就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。2019年,該藥品未進行銷售。截至本公告日,中國境內該藥品的主要生產廠家為重慶藥友製藥有限責任公司、四川科倫藥業股份有限公司、宜昌人福藥業有限責任公司等。IQVIA數據庫顯示,2019年該藥品口服劑型醫院採購金額為人民幣55,426萬元,其中膠囊劑醫院採購金額為人民幣1901萬元。
截至本公告日,公司針對該藥品的一致性評價已投入研發費用約人民幣693.64萬元。
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