龍津藥業(002750.SZ):注射用生長抑素獲得藥品批准文號
格隆匯11月8日丨龍津藥業(002750.SZ)公佈,公司近日收到國家藥品監督管理局送達的《藥品補充申請批准通知書》(通知書編號:2021B03844),獲悉公司申請的增加註射用生長抑素規格(3mg)已通過審批,並獲得藥品批准文號。藥品通用名稱:注射用生長抑素;劑型:注射劑;規格:3mg。
注射用生長抑素主要用於消化系統出血的臨牀治療,是胃靜脈曲張出血一線治療藥物、垂體促甲狀腺激素腺瘤首選用藥,屬2020年版國家醫保乙類品種、七大權威指南推薦用藥,與天然生長抑素在化學結構和作用機理上完全相同。根據米內網數據,注射用生長抑素2020年國內城市公立醫院銷售額約17.98億元,且2015年以來年銷售規模均超過17億元;2020年國內市場最大份額為原研廠家德國默克(Merck)佔有(41.61%),其次為揚子江(21.53%)、瀚宇2藥業(11.30%)、成都天台山製藥(7.93%),其餘廠家市場份額均低於5%。
本次獲得注射用生長抑素新增規格註冊批文,有利於公司優化產品結構、提高市場競爭力,有助於公司培養新的利潤增長點。公司原有注射用生長抑素0.25mg規格批文(國藥準字H20066787)因市場和產能原因未安排產品生產,新增3mg規格產品預計2022年第一季度可實現銷售,將對公司市場開發和產品銷售產生積極影響,但不會對公司本期經營業績產生重大影響。
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