白雲山(600332.SH):分公司苯磺酸氨氯地平片通過一致性評價
格隆匯3月8日丨白雲山(600332.SH)宣佈,2021年3月8日,公司分公司廣州白雲山醫藥集團股份有限公司白雲山製藥總廠(“白雲山製藥總廠”)收到國家藥品監督管理局簽發的《藥品補充申請批准通知書》(通知書編號:2021B00498),苯磺酸氨氯地平片已通過仿製藥質量和療效一致性評價。
苯磺酸氨氯地平是二氫吡啶類鈣拮抗劑,用於治療原發性高血壓、慢性穩定性心絞痛及變異型心絞痛。
白雲山製藥總廠苯磺酸氨氯地平片於2007年10月在國內正式上市,並於2019年9月26日向國家藥品監督管理局遞交一致性評價申請,於2019年10月25日獲得受理。
目前中國境內上市的苯磺酸氨氯地平片的生產廠家還包括輝瑞製藥有限公司、華潤賽科藥業有限責任公司、揚子江藥業集團上海海尼藥業有限公司、浙江尖峯藥業有限公司、昆明賽諾製藥股份有限公司等。根據米內網數據顯示,2019年苯磺酸氨氯地平片在中國公立醫院和城市零售藥店的銷售收入分別為人民幣37.31億元和人民幣21.95億元。
截至公吿日,白雲山製藥總廠針對該藥品一致性評價已投入研發費用約人民幣437.88萬元(未經審計)。2019年度白雲山製藥總廠該藥品的銷售收入為人民幣129萬元,約佔白雲山製藥總廠2019年度的營業收入的0.0335%,約佔公司2019年度的營業收入的0.0020%。
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