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國藥現代(600420.SH):子公司頭孢丙烯幹混懸劑通過仿製藥一致性評價
格隆匯 10-19 16:30

格隆匯10月19日丨國藥現代(600420.SH)公佈,近日,公司全資子公司國藥集團汕頭金石製藥有限公司(“國藥金石”)收到國家藥品監督管理局核准簽發的頭孢丙烯幹混懸劑(0.125g)《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價。

頭孢丙烯為長效、廣譜的第二代頭孢菌素類抗生素,臨牀上一般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、皮膚軟組織感染等。該藥品最早由美國Bristol-MyersSquibb公司研發,於1991年首次在美國上市。

根據PDB藥物綜合數據庫數據顯示,頭孢丙烯幹混懸劑2020年在全球銷售額為1.172億美元;國內樣本醫院銷售額為人民幣1.309億元。

CDE網站顯示,目前頭孢丙烯幹混懸劑(0.125g)通過一致性評價的企業還有南京億華藥業有限公司、海南日中天製藥有限公司。國藥金石用於開展頭孢丙烯幹混懸劑(0.125g)一致性評價累計研發投入約人民幣285萬元(未經審計)。

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