上海醫藥(02607.HK):辛伐他汀片通過仿製藥一致性評價
格隆匯5月18日丨上海醫藥(02607.HK)公佈,近日,公司控股子公司上海信誼萬象藥業股份有限公司(以下簡稱"信誼萬象")收到國家藥品監督管理局(以下簡稱"國家藥監局")頒發的關於辛伐他汀片(規格 10mg、20mg,以下簡稱"該藥品")的《藥品補充申請批准通知書》(通知書編號:2021B01317、2021B01318),該藥品通過仿製藥質量和療效一致性評價。
辛伐他汀片主要適用於高脂血症、冠心病、患有雜合子家族性高膽固醇血癥的兒童患者,由 Merck Sharp & Dohme Limited 研發,最早於 1991 年在美國上市。2019 年 1月,信誼萬象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。截至公吿日,公司針對該藥品的一致性評價已投入研發費用約人民幣 1,027 萬元。
截至公吿日,中國境內該藥品的主要生產廠家為瀚暉製藥有限公司、浙江京新藥業股份有限公司、福建東瑞製藥有限公司、廣州南新制藥有限公司等。IQVIA 數據庫顯示,2020 年該藥品口服片劑醫院採購金額為人民幣 24,212 萬元。2020 年,信誼萬象的辛伐他汀片銷售收入為人民幣 1,254 萬元。
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