新天藥業(002873.SZ):匯倫江蘇藥業獲得“注射用艾司奧美拉唑鈉”藥品註冊批件
格隆匯3月22日丨新天藥業(002873.SZ)公佈,公司參股公司上海匯倫生物科技有限公司(“匯倫生物”)的全資子公司上海匯倫江蘇藥業有限公司(“匯倫江蘇藥業”)於2020年3月21日收到國家藥品監督管理局核准簽發的《藥品註冊批件》(批件號:2020S00131),藥品名稱為注射用艾司奧美拉唑鈉。
注射用艾司奧美拉唑鈉的適應症為:作為當口服療法不適用時,胃食管反流病的替代療法;用於口服療法不適用的急性胃或十二指腸潰瘍出血的低危患者(胃鏡下Forrest分級IIc-III)。
注射用艾司奧美拉唑鈉為新一代注射用質子泵抑制劑,可以通過抑制特異性的質子泵,以減少胃酸分泌,對基礎胃酸分泌和受刺激後的胃酸分泌產生很好的抑制作用。本品在維持治療和按需治療中良好的依從性、耐受性,均受到了臨牀認可。
匯倫生物的全資子公司匯倫江蘇藥業此次獲得“注射用艾司奧美拉唑鈉”藥品註冊批件,有利於公司進一步優化產業佈局,加快進入小分子化藥領域,包括抗腫瘤、心腦血管、呼吸及消化系統等疾病的仿製藥及創新藥領域,對公司未來發展將產生積極影響,但不會對公司當期經營業績產生重大影響。
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