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科倫藥業(002422.SZ):鹽酸氨溴索注射液通過仿製藥一致性評價
格隆匯 01-04 18:15

格隆匯 1 月 4日丨科倫藥業(002422.SZ)公佈,公司子公司湖北科倫藥業有限公司於近日獲得國家藥品監督管理局核准簽發的化學藥品酸氨溴索注射液的《藥品補充申請批准通知書》。

近日公司的鹽酸氨溴索注射液通過一致性評價並獲得藥品補充申請批准通知書,主要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,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等。

氨溴索屬於黏液動力藥,對肺組織特異性較高,能顯著促進排痰和減少咳嗽及痰量,且對呼吸系統具有保護作用,為目前臨牀最常用的祛痰藥之一,廣泛應用於呼吸科、外科、兒科等,已被《祛痰/抗氧化藥治療慢性阻塞性肺疾病中國專家共識(2015年)》、《慢性氣道炎症性疾病氣道黏液高分泌管理中國專家共識(2018年)》、《胸外科圍手術期肺保護中國專家共識(2019年)》等國內權威指南和專家共識推薦。氨溴索國內上市多種劑型,其中注射液尤其適用於危重、術後及不適宜口服給藥的排痰困難患者。鹽酸氨溴索注射液為2020版國家醫保目錄品種,2019年中國公立醫院銷售額35.9億元。

目前公司在呼吸領域已建立起覆蓋呼吸道感染、祛痰治療、哮喘與COPD、肺部腫瘤等全科室產品集羣,且已有10餘項相關產品獲批或通過一致性評價。此次公司鹽酸氨溴索注射液通過一致性評價,將進一步提升該品種的市場競爭力。

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