健康元(600380.SH):苯磺酸氨氯地平膠囊通過仿製藥一致性評價
格隆匯9月28日丨健康元(600380.SH)公佈,近日,公司控股子公司麗珠集團全資子公司麗珠製藥廠收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,麗珠製藥廠生產的苯磺酸氨氯地平膠囊通過仿製藥質量和療效一致性評價。
苯磺酸氨氯地平膠囊是《國家基本醫療保險、工傷保險和生育保險藥品目錄》甲類品種,適應症:1、高血壓。本品適用於高血壓的治療。本品可單獨應用或與其他抗高血壓藥物聯合應用。2、冠心病。(1)慢性穩定性心絞痛:本品適用於慢性穩定性心絞痛的對症治療。可單獨應用或與其他抗心絞痛藥物聯合應用。(2)血管痙攣性心絞痛(Prinzmetal’s或變異型心絞痛):本品適用於確診或可疑的血管痙攣性心絞痛的治療。可單獨應用也可與其他抗心絞痛藥物聯合應用。(3)經血管造影證實的冠心病:經血管造影證實為冠心病,但射血分數≥40%且無心力衰竭的患者,本品可減少因心絞痛住院的風險以及降低冠狀動脈重建術的風險。
截至本公告披露日,苯磺酸氨氯地平膠囊一致性評價已累計投入的直接研發費用約為人民幣1069.31萬元。
目前,國內共有2家企業持有苯磺酸氨氯地平膠囊生產批文,麗珠製藥廠是首家通過本品一致性評價的企業。根據IQVIA抽樣統計估測數據,氨氯地平口服制劑產品2019年度國內終端銷售金額約為人民幣25.95億元,其中苯磺酸氨氯地平膠囊2019年度國內終端銷售金額約為人民幣1620.59萬元。
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