上海醫藥(601607.SH)：鹽酸氨溴索膠囊及卡託普利片通過仿製藥一致性評價
格隆匯4月7日丨上海醫藥(601607.SH)公佈，近日，公司全資子公司上海信誼天平藥業有限公司(“信誼天平”)及控股子公司常州製藥廠有限公司(“常州製藥”)分別收到國家藥品監督管理局(“國家藥監局”)頒發的關於鹽酸氨溴索膠囊及卡託普利片的《藥品補充申請批件》，上述藥品通過仿製藥一致性評價。
鹽酸氨溴索膠囊主要適用於急、慢性呼吸道疾病，如急、慢性支氣管炎、支氣管哮喘、支氣管擴張，肺結核等引起的痰液粘稠，咳痰困難，由德國勃林格殷格翰公司研發，最早於1978年在德國上市。2019年1月，信誼天平就鹽酸氨溴索膠囊向國家藥監局提出一致性評價申請並獲受理。截至公告日，公司針對鹽酸氨溴索膠囊的一致性評價已投入研發費用約人民幣680萬元。2019年信誼天平鹽酸氨溴索膠囊實現銷售收入為人民幣487萬元。
截至公告日，鹽酸氨溴索膠囊在中國境內的主要生產廠家為安徽省先鋒製藥有限公司、四川大冢製藥有限公司等。IQVIA數據庫顯示，2019年鹽酸氨溴索口服膠囊劑醫院採購金額為人民幣883萬元。
卡託普利片主要用於治療高血壓和心力衰竭，由Bristol-Myers Squibb公司研發，最早於1981年在美國上市。2018年10月，常州製藥就卡託普利片向國家藥監局提出一致性評價申請並獲受理。截至公告日，公司針對卡託普利片(12.5mg和25mg)的一致性評價已投入研發費用約人民幣528.84萬元。2019年常州製藥卡託普利片(12.5mg)未進行銷售；卡託普利片(25mg)實現銷售收入為人民幣14381萬元。
截至公告日，中國境內該藥品的主要生產廠家為山東羅欣藥業集團股份有限公司、上海旭東海普藥業有限公司、中美上海施貴寶製藥有限公司等。IQVIA數據庫顯示，2019年卡託普利片(12.5mg和25mg)醫院採購金額為人民幣1523萬元。
公司控股子公司常州製藥已於2018年完成了卡託普利片(25mg)的仿製藥一致性評價工作。
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