昂利康(002940.SZ)：苯磺酸左氨氯地平片通過一致性評價
格隆匯1月4日丨昂利康(002940.SZ)公佈，近日，公司通過國家藥品監督管理局網站獲悉，公司苯磺酸左氨氯地平片(2.5mg)和苯磺酸左氨氯地平片(5mg)均已通過仿製藥質量和療效一致性評價。
苯磺酸左氨氯地平為苯磺酸氨氯地平的左旋異構體，屬於二氫吡啶類鈣離子通道阻滯劑，其適應症為高血壓、心絞痛。苯磺酸左氨氯地平片的原研單位為施慧達藥業集團(吉林)有限公司。公司該次通過一致性評價的2個規格藥品均已被列入《國家基本醫療保險、工傷保險和生育保險藥品目錄(2021年)》乙類藥品，其中2.5mg規格藥品被列入《國家基本藥物目錄(2018年版)》。
截止該公吿日，國內共有2個規格17個左氨氯地平片生產批文(其中15個生產批文為苯磺酸左氨氯地平片，2個生產批文為馬來酸左氨氯地平片)，中國境內左氨氯地平片的主要生產廠家有施慧達藥業集團(吉林)有限公司、石藥集團歐意藥業有限公司以及公司等。根據米內網的數據顯示，自2016年以來，公司生產的苯磺酸左氨氯地平片一直佔據中國城市公立醫院(樣本醫院)化學藥左氨氯地平片銷售額排名第三位。
公司分別於2019年5月7日、2019年6月27日向國家藥品監督管理局藥品審評中心遞交苯磺酸左氨氯地平片5mg、2.5mg的一致性評價補充申請，分別於2019年5月29日、2019年7月19日獲得受理。截至該公吿日，共有2個廠家的3個苯磺酸左氨氯地平片生產批文通過國家藥品監督管理局仿製藥質量和療效一致性評價審批。其中公司苯磺酸左氨氯地平片(5mg)為國內首家通過一致性評價，苯磺酸左氨氯地平片(2.5mg)為國內首批通過一致性評價。
截至該公吿日，公司該藥品已投入的累計研發金額約為人民幣1859.81萬元(未經審計)。
目前，苯磺酸左氨氯地平片是公司主營業務的核心產品，對公司收入和利潤的影響較大，2020年度，公司營業收入總額為12.90億元人民幣，其中苯磺酸左氨氯地平片銷售收入佔營業收入總額的54.90%。此次，公司2個規格的苯磺酸左氨氯地平片均通過仿製藥質量和療效一致性評價，將進一步提升該藥品的市場競爭力。
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