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上海醫藥(601607.SH):硫酸羥氯喹片通過仿製藥一致性評價
格隆匯 01-28 16:21

格隆匯1月28日丨上海醫藥(601607.SH)公佈,近日,公司控股子公司上海上藥中西製藥有限公司(以下簡稱“上藥中西”)收到國家藥品監督管理局頒發的關於硫酸羥氯喹片的《藥品補充申請批准通知書》,該藥品通過仿製藥一致性評價。

硫酸羥氯喹片主要用於類風濕關節炎、青少年慢性關節炎、盤狀和系統性紅斑狼瘡、以及由陽光引發或加劇的皮膚疾病,由Concordia Pharmaceuticals Inc研發,於1955年在美國上市。2020年7月,上藥中西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。截至本公吿日,上藥中西針對該藥品的一致性評價已投入研發費用約人民幣2000.59萬元。

截至本公吿日,中國境內該藥品生產廠家僅有上海上藥中西製藥有限公司和賽諾菲安萬特製藥公司2家企業。

IQVIA數據庫顯示,2020年硫酸羥氯喹片醫院採購金額為人民幣89221萬元。2021年,上藥中西該藥品的銷售收入為人民幣100518萬元。

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