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昂利康(002940.SZ):頭孢克洛緩釋片(0.375g)通過一致性評價
格隆匯 07-24 19:51

格隆匯 7 月 24日丨昂利康(002940.SZ)公佈,近日,公司通過國家藥品監督管理局網站獲悉,公司頭孢克洛緩釋片(規格0.375g)已通過仿製藥質量和療效一致性評價。

藥品名稱:頭孢克洛緩釋片;規格:0.375g(按C15H14ClN3O4S計);批准文號:國藥準字H20020456;註冊分類:化學藥品;申請人:浙江昂利康製藥股份有限公司;申請事項:仿製藥質量和療效一致性評價;受理號:CYHB1950388國;審批結論:本品通過仿製藥質量和療效一致性評價

頭孢克洛緩釋片是第二代頭孢菌素類藥物,原研廠商為美國禮來公司。該藥品臨牀適用於敏感病原菌所致的下列感染:急性支氣管炎和慢性支氣管炎急性發作、咽炎、扁桃體炎、肺炎、鼻竇炎、單純性下尿路感染、皮膚軟組織感染。頭孢克洛緩釋片已被列入《國家醫保目錄(2019年版)》,類別為乙類藥品。

公司就該藥品於2019年04月22日向國家藥品監督管理局藥品審評中心遞交補充申請,於2019年05月21日獲得受理。公司為頭孢克洛緩釋片國內首家通過仿製藥質量和療效一致性評價的企業。

截至公告披露日,公司對該藥品一致性評價累計研發投入金額約為人民幣1731.61萬元(未經審計)。

公司頭孢克洛緩釋片(0.375g)通過一致性評價,有利於提升該產品的市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累經驗。

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