國藥現代(600420.SH):子公司藥品醋酸奧曲肽注射液通過仿製藥一致性評價
格隆匯11月15日丨國藥現代(600420.SH)公佈,近日,公司控股子公司國藥一心製藥有限公司(“國藥一心”)收到國家藥品監督管理局核准簽發的醋酸奧曲肽注射液《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。
醋酸奧曲肽是人工合成的八肽化合物,可以抑制促黃體生成素對促性腺激素釋放激素的反應、降低內臟血流,抑制5-羥色胺、胃泌素、血管活性腸肽、糜蛋白酶、胃動素、胰高血糖素的分泌。主要適用於需要長期給藥的肢端肥大症及一些消化道類癌、神經內分泌腫瘤。醋酸奧曲肽最初由諾華公司研發,於1988年首次在美國上市。
根據米內網數據,醋酸奧曲肽注射液2020年全國公立醫院銷售額為人民幣15.24億元。國藥一心醋酸奧曲肽注射液2020年的銷售收入約為人民幣2.54億元(不含税)。
CDE網站顯示,目前醋酸奧曲肽注射液通過一致性評價的企業還有本溪恆康製藥有限公司等。國藥一心用於開展醋酸奧曲肽注射液(1ml:0.1mg)一致性評價累計研發投入約人民幣1297.89萬元(未經審計)。
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