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華潤雙鶴(600062.SH):鹽酸氨溴索注射液通過仿製藥一致性評價
格隆匯 03-04 16:51

格隆匯3月4日丨華潤雙鶴(600062.SH)公佈,近日,公司全資子公司華潤雙鶴利民藥業(濟南)有限公司(以下簡稱“雙鶴利民”)收到了國家藥監局頒發的鹽酸氨溴索注射液《藥品補充申請批准通知書》,該藥品通過仿製藥質量和療效一致性評價(以下簡稱“一致性評價”)。

鹽酸氨溴索注射液適用於伴有痰液分泌不正常及排痰功能不良的急性、慢性肺部疾病。

雙鶴利民自2019年啟動該藥品的一致性評價工作,於2020年12月21日向國家藥監局提交一致性評價申請,於2020年12月29日獲得受理通知書,並於2022年2月18日獲得國家藥監局批准通過一致性評價。截至本公吿日,雙鶴利民就該藥品開展一致性評價累計研發投入為人民幣464.62萬元(未經審計)。

鹽酸氨溴索注射液由Boehringer Ingelheim Pharma GmbH& Co.KG(勃林格殷格翰)研製,商品名為Mucosolvan,於1980年在德國獲批。根據目前獲取的全球71國家藥品銷售數據庫顯示,2020年Mucosolvan全球銷售額為6530萬美元。

國內市場,根據國家藥監局信息顯示,中國境內已批准上市的鹽酸氨溴索注射液有52家,通過一致性評價的生產企業有31家(含雙鶴利民);根據米內網數據顯示,2020年國內醫療市場鹽酸氨溴索注射液銷售總額(終端價)為23.84億元,其中市場份額排名前5名的企業分別為勃林格殷格翰38.4%、天津藥物研究院藥業16.06%、山東羅欣藥業集團9.51%、雲南龍海天然植物藥業6.34%、國藥國瑞藥業5.41%。

雙鶴利民該藥品2020年銷售收入為260.47萬元。

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