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山東新華製藥股份(00719.HK):全資子公司阿莫西林膠囊通過仿製藥一致性評價

格隆匯1月17日丨山東新華製藥股份(00719.HK)公佈,近日,公司全資子公司山東淄博新達製藥有限公司("新達製藥")收到國家藥品監督管理局核准簽發的阿莫西林膠囊("該產品")《藥品補充申請批准通知書》,該產品一致性評價申請獲得批准。

2020年11月,新達製藥向國家藥品監督管理局CDE遞交了阿莫西林膠囊(規格:按C16H19N3O5S計0.25g)仿製藥質量和療效一致性評價申請並獲受理,2021年5月收到CDE發出的補充研究通知,2021年6月完成補充研究工作並遞交資料,2022年1月獲得《藥品補充申請批准通知書》,審評結論為通過仿製藥質量和療效一致性評價。

阿莫西林膠囊由GSK公司開發,並於1972年在英國上市,商品名Amoxil,後相繼在美國、西班牙、日本等國上市。阿莫西林為青黴素類抗生素,對肺炎鏈球菌、溶血性鏈球菌等鏈球菌屬、不產青黴素酶葡萄球菌、糞腸球菌等需氧革蘭陽性球菌,大腸埃希菌、奇異變形桿菌、沙門菌屬、流感嗜血桿菌、淋病奈瑟菌等需氧革蘭陰性菌的不產β-內酰胺酶菌株及幽門螺桿菌具有良好的抗菌活性。有關數據顯示,2020年阿莫西林膠囊在中國公立醫院及城市零售藥店的銷售總額約13.21億元。

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