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上海醫藥(02607.HK):苯磺酸氨氯地平片通過仿製藥一致性評價
格隆匯 04-27 18:05

格隆匯4月27日丨上海醫藥(02607.HK)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")收到國家藥監局頒發的關於苯磺酸氨氯地平片的《藥品補充申請批件》(批件號:2020B02867),該藥品通過仿製藥一致性評價。

據悉,苯磺酸氨氯地平片主要適用於高血壓、慢性穩定性心絞痛、變異型心絞痛以及經血管造影證實的冠心病,由Pfizer公司研發,最早於1989年在英國上市。2019年1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657.11萬元。

IQVIA數據庫顯示,2019年該藥品(口服片劑)醫院採購金額為人民幣259,678萬元。2019年,上藥中西的苯磺酸氨氯地平片未發生銷售。

截至公告日,中國境內該藥品的主要生產廠家為輝瑞製藥有限公司、華潤賽科藥業有限責任公司、蘇州東瑞製藥有限公司、重慶藥友製藥有限責任公司和國藥集團容生製藥有限公司等。

該藥品作為藥品上市許可持有人制度試點品種,上市許可持有人為公司控股子公司上海上藥中西製藥有限公司,受託生產企業為公司控股子公司常州製藥廠有限公司。

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