北大醫藥(000788.SZ):成為鹽酸曲美他嗪緩釋片上市許可持有人
格隆匯1月10日丨北大醫藥(000788.SZ)公佈,近日,公司收到國家藥監局核准簽發的關於鹽酸曲美他嗪緩釋片的《藥品補充申請批准通知書》。經審查,該藥品此次申請事項符合藥品註冊的有關要求,同意按照《藥品上市後變更管理辦法(試行)》相關規定,批准該藥品上市許可持有人由“北京百特美生物製藥有限公司(地址:北京市平谷區中關村科技園區平谷園興谷A區M2-9號)”變更為“北大醫藥股份有限公司(地址:重慶市北碚區水土鎮方正大道21號)”,藥品批准文號不變。
曲美他嗪是治療心絞痛的代謝類藥物,其通過改善心肌細胞代謝,提高運動耐量而發揮作用。曲美他嗪普通片劑每日服藥3次,藥效無法覆蓋24小時,存在凌晨0點-8點的“清晨空窗期”,但清晨4-8時為心絞痛的發病高峯。鹽酸曲美他嗪緩釋片(2次/天)的主要優勢為顯著改善了藥代動力學特點,從而使抗心肌缺血療效更持久,有效地覆蓋清晨危險時段。鹽酸曲美他嗪緩釋片的有效性與顯著的安全性已充分得到了臨牀和市場的認可,也是治療指南推薦用藥,其市場容量大。
鹽酸曲美他嗪緩釋片因其較高的臨牀價值,未來市場前景良好,公司該產品的獲批上市,進一步完善了公司在心血管疾病領域的產品結構,有利於提升公司在心血管疾病領域產品市場的競爭力,對公司未來業績的提升有積極作用。
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