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一品紅(300723.SZ):子公司硝苯地平控釋片獲批上市
格隆匯 02-09 15:52

格隆匯2月9日丨一品紅(300723.SZ)公佈,公司全資子公司廣州一品紅製藥有限公司於近日收到國家藥品監督管理局核准簽發的《藥品註冊證書》。藥品通用名稱:硝苯地平控釋片;規格:30mg、60mg。

根據核准的藥品説明書,公司研發的硝苯地平控釋片用於治療高血壓、冠心病(慢性穩定型心絞痛即勞累性心絞痛)。

硝苯地平又名心痛定,是第一個二氫吡啶類鈣拮抗劑;可選擇性抑制鈣離子進入心肌細胞和平滑肌細胞的跨膜轉運,並抑制鈣離子從細胞內庫釋放,而不改變血漿鈣離子濃度,臨牀上用於治療高血壓和心絞痛。

與第一代硝苯地平普通片劑相比,第二代硝苯地平控釋片通過控釋衣膜定時、定量、勻速地向外釋放藥物,使血藥濃度恆定,控制了血壓忽高忽低的“峯谷”現象,遏制了交感神經興奮的副作用,有效地減少了副作用,從而更好地發揮療效。

硝苯地平控釋片屬於 2021年版國家醫保甲類產品,公司獲批的硝苯地平控釋片是以化學藥品4類申報註冊,視同通過仿製藥一致性評價。據米內網數據顯示,2020年硝苯地平在中國城市公立醫院、縣級公立醫院、城市社區中心以及鄉鎮衞生院(簡稱中國公立醫療機構)及中國城市實體藥店終端合計銷售規模超過60億元人民幣。

此次獲得硝苯地平控釋片註冊證書,標誌着公司具備了在國內市場銷售該藥品的資格,將進一步豐富了公司產品管線和品類,增強公司在慢病領域的競爭力。

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