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魯抗醫藥(600789.SH):頭孢氨苄片通過仿製藥一致性評價
格隆匯 05-11 18:44

格隆匯5月11日丨魯抗醫藥(600789.SH)公佈,近日,公司收到國家藥品監督管理局頒發的關於頭孢氨苄片(該藥品)的藥品補充申請批准通知書(通知書編號:2021B01170)該藥品通過仿製藥質量和療效一致性評價。

頭孢氨苄為第一代頭孢菌素,屬β-內酰胺類。頭孢氨苄的作用機制是通過與細菌一個或多個青黴素結合蛋白(PBPs)相結合(頭孢氨苄主要與PBP-3結合),抑制細菌分裂細胞的細胞壁合成,從而起抗菌作用臨牀適用於敏感菌所致的急性扁桃體炎、咽峽炎、鼻竇炎、支氣管炎、肺炎等呼吸道感染、中耳炎、尿路感染及皮膚軟組織感染等。被《抗菌藥物臨牀應用指導原則》(2015年版)推薦第一代頭孢菌素為急性細菌性呼吸道感染、尿路感染、皮膚軟組織感染的宜選或可選用藥,並被《2018NICE/PHE指南:導尿管相關尿路感染的抗菌藥物處方》推薦為一線用藥。現國內上市劑型為片劑、膠囊劑、顆粒劑等劑型頭孢氨苄片已進入2020年國家甲類醫保目錄,是最早進入我國基本藥物目錄的品種之一。

經查詢米內網數據庫,全國現有頭孢氨苄片批文164,生產廠家111家,其中0.25g規格的生產廠家105家。2020年,頭孢氨苄片國內銷售額約9000人民幣,公司該產品的銷售收入528.04萬元。

目前國內1個廠山東新華製藥股份有限公司(0.125g0.25g)通過家藥品監督管理局一致性評價審批公司為第二家獲批

該藥品開展一致性評價工作以來,公司累計研發投入1229.57萬元民幣(未經審計)

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