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羅欣藥業(002793.SZ):注射用美羅培南通過仿製藥質量和療效一致性評價
格隆匯 01-17 16:06

格隆匯1月17日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司山東羅欣藥業集團股份有限公司(山東羅欣)於近日收到國家藥品監督管理局核準簽發的注射用美羅培南《藥品補充申請批准通知書

審批結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)、《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號)和《國家藥監局關於開展化學藥品注射劑仿製藥質量和療效一致性評價工作的公吿》(2020年第62號)的規定,經審查,本品通過仿製藥質量和療效一致性評價。

美羅培南為人工合成的廣譜和強效的碳青黴烯類β內酰胺抗生素通過抑制細菌細胞壁的合成而產生抗菌作用。美羅培南容易穿透大多數革蘭氏菌的細胞壁,而達到其作用靶點青黴素結合蛋白(PBPs)。除金屬β-內酰胺酶以外,其對大多β-內酰胺酶(包括由革蘭氏菌所產生的青黴素酶和頭孢菌素酶)的水解作用具有較強的穩定性。美羅培南適用於成人和兒童由單一或多種對美羅培南敏感的細菌引起的感染,單用或與其它抗微生物製劑聯合使用可用於治療多重感染。

注射用美羅培南最早由 Sumitomo Dainippon Pharma Co.,Ltd.公司研發,1994年在意大利上市,商品名 Mepem®1999原研在中國進口上市,商品美平®山東羅欣研製的注射用美羅培南 2016 年首次獲准上市,批准文號:國藥準字H20163391國藥準字H20163392

根據IQVIA數據,2020年度注射用美羅培南的全球市場規模為16.33億美元(以出廠價計算)根據IQVIA及米內網數據,注射用美羅培南2020年度在我國境內銷售金額為51.3億人民幣(以招標價計算)

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