億帆醫藥(002019.SZ):鹽酸氨溴索注射液獲得藥品註冊證書
格隆匯1月7日丨億帆醫藥(002019.SZ)公佈,公司全資子公司合肥億帆生物製藥有限公司於2022年1月7日收到國家藥品監督管理局核准簽發的鹽酸氨溴索注射液《藥品註冊證書》。
鹽酸氨溴索注射液適用於伴有痰液分泌不正常及排痰功能不良的急性、慢性肺部疾病,例如慢性支氣管炎急性加重、喘息型支氣管炎及支氣管哮喘的祛痰治療;手術後肺部併發症的預防性治療;早產兒及新生兒的呼吸窘迫綜合症(IRDS)的治療。
公司於2020年9月向國家藥品監督管理局藥品審評中心遞交了藥品註冊申請,於2020年10月獲得受理,並於2022年1月收到鹽酸氨溴索注射液《藥品註冊證書》,本次鹽酸氨溴索注射液以化學藥品註冊分類4類獲批上市,標誌着此產品視同通過仿製藥一致性評價。
根據米內網數據顯示,2020年鹽酸氨溴索注射劑市場規模約36.78億。
截止目前,該產品已投入研發費用約707.34萬元。
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