康恩貝(600572.SH):子公司玻璃酸鈉滴眼液獲藥品註冊批件
格隆匯4月20日丨康恩貝(600572.SH)公佈,近日,公司控股子公司江西珍視明藥業有限公司(“珍視明藥業公司”)收到國家食品藥品監督管理總局核准簽發的玻璃酸鈉滴眼液《藥品註冊批件》。
玻璃酸鈉滴眼液是國內治療乾眼症的常用藥,已列入《國家醫保目錄(2019年版)》,類別為乙類藥品,其適應症為用於伴隨下述疾患的角結膜上皮損傷;乾燥綜合徵,斯·約二氏綜合徵,乾眼綜合徵等內因性疾患;手術後、藥物性、外傷、佩戴隱形眼鏡等外因性疾患。
玻璃酸鈉滴眼液是珍視明藥業公司於2015年自主研發的產品,於2017年2月遞交了該品種的註冊申請,並於近日獲得國家食品藥品監督管理總局核准簽發的玻璃酸鈉滴眼液《藥品註冊批件》。截至目前,珍視明藥業公司對該產品已投入研發費用人民幣約394萬元。
根據國家藥品審評中心(CDE)網站顯示,截至公告日,國內共有18家企業獲得玻璃酸鈉滴眼液藥品註冊批件,4家企業正在審評中。按化學藥品4類申報生產玻璃酸鈉滴眼液的企業中,已有公司子公司珍視明藥業公司和成都普什製藥有限公司獲得藥品註冊批件。
米內網全國放大版數據顯示,國內2018年玻璃酸鈉眼用製劑銷售額13.16億元,同比增長24.01%。
珍視明藥業公司玻璃酸鈉滴眼液的獲批生產上市,增加了公司產品種類,提高了公司在治療乾眼症藥物領域的競爭力,對公司業績將產生積極影響。
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