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上海醫藥(601607.SH):布洛芬緩釋膠囊(0.3g)通過仿製藥一致性評價
格隆匯 11-21 16:56

格隆匯11月21日丨上海醫藥(601607.SH)公佈,近日,公司全資子公司信誼天平收到國家藥監局頒發的關於布洛芬緩釋膠囊(0.3g)的《藥品補充申請批件》(批件號:2019B04227),該藥品通過仿製藥一致性評價。

布洛芬緩釋膠囊主要用於緩解輕至中度疼痛,以及普通感冒或流行性感冒引起的發熱,由葛蘭素史克公司研發,最早於1988年在約旦上市。2018年7月,信誼天平就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。截至公告日,公司針對該藥品的一致性評價已投入研發費用約人民幣788萬元。

截至公告日,中國境內該藥品的主要生產廠家為上海愛的發製藥有限公司、中美天津史剋制藥有限公司、珠海潤都製藥股份有限公司和珠海聯邦制藥股份有限公司等。IQVIA數據庫顯示,2018年該藥品醫院採購金額為人民幣6107.73萬元。信誼天平2018年該藥品實現銷售收入為人民幣1185.79萬元。

根據國家相關政策,通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。因此信誼天平的布洛芬緩釋膠囊(0.3g)通過仿製藥質量和療效一致性評價,有利於擴大該藥品的市場份額,提升市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。

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