翰宇藥業(300199.SZ):醋酸特利加壓素原料藥獲得上市申請批准通知書
格隆匯12月16日丨翰宇藥業(300199.SZ)公佈,2022年12月16日,公司全資子公司翰宇藥業(武漢)有限公司(簡稱“翰宇武漢”)醋酸特利加壓素原料藥收到國家藥監局簽發的《化學原料藥上市申請批准通知書》(受理號:CYHS2160053),並在國家藥監局藥品審評中心官方網站公示。
本品原料藥用於注射用特利加壓素製劑的生產。特利加壓素是一種合成的血管加壓素類似物,屬於血管活性藥物中的縮血管藥物,主要用於肝硬化靜脈曲張出血的止血。現臨牀廣泛應用於肝腎綜合徵、肝硬化腹水、感染性休克、燒傷、急性肝功能衰竭、心臟驟停等的治療。
公司表示,該次醋酸特利加壓素原料藥通過國家藥監局藥品審評中心技術審評,標誌着翰宇武漢取得該原料藥國內市場銷售資格,將進一步推動原料藥銷售業務增長。
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