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現代製藥(600420.SH):頭孢呋辛酯膠囊通過仿製藥一致性評價
格隆匯 12-02 16:39

格隆匯12月2日丨現代製藥(600420.SH)公佈,近日,公司控股子公司國藥集團致君(深圳)製藥有限公司(以下簡稱“國藥致君”)收到國家藥監局核准簽發的頭孢呋辛酯膠囊(0.125g)《藥品補充申請批件》,批准該藥品通過仿製藥質量和療效一致性評價。

頭孢呋辛酯膠囊是頭孢菌素類抗感染藥,臨牀主要用於治療由敏感細菌引起的感染性疾病,包括上呼吸道感染、下呼吸道感染、泌尿道感染、皮膚軟組織感染、耳鼻部感染、急性無併發症淋病等。原研品種為葛蘭素史克公司的頭孢呋辛酯片,藥品商品名為“西力欣”。

根據PDB藥物綜合數據庫數據顯示,頭孢呋辛酯2018年在全球銷售額為6.64億美元;國內樣本醫院銷售額為人民幣9263.23萬元。2018年國藥致君頭孢呋辛酯膠囊(0.125g)銷售收入(不含税)約為人民幣7000萬元。

國內擁有頭孢呋辛酯膠囊(0.125g)規格藥品生產批文的還有宜昌人福藥業有限責任公司、浙江瑞新藥業股份有限公司、深圳立健藥業有限公司等。經查詢,目前除國藥致君外國內尚無其他公司上述相同規格藥品通過一致性評價。截至目前,國藥致君用於開展頭孢呋辛酯膠囊(0.125g)一致性評價累計投入費用約人民幣1500餘萬元(未經審計)。

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