健康元(600380.SH):鹽酸左沙丁胺醇霧化吸入溶液被納入醫保目錄“協議期內談判藥品部分”
格隆匯 12 月 28日丨健康元(600380.SH)公佈,2020年12月28日,國家醫療保障局(以下簡稱:醫保局)發佈新版《國家基本醫療保險、工傷保險和生育保險藥品目錄(2020年)》(醫保發〔2020〕53號,以下簡稱:《醫保目錄》)。公司的獨家品種鹽酸左沙丁胺醇霧化吸入溶液(3ml:0.63mg/支、3ml:0.31mg/支)被納入《國家基本醫療保險、工傷保險和生育保險藥品目錄》“協議期內談判藥品部分”。
鹽酸左沙丁胺醇霧化吸入溶液為國內首仿獲批的3類化學藥品,國家科技重大專項品種,此次《醫保目錄》“協議期內談判藥品部分”中唯一納入的國產吸入製劑。3ml:0.63mg規格於2019年9月26日獲批生產,3ml:0.31mg規格以“兒童專用劑型”於2020年8月13日獲得藥品補充申請批准。獲批上市以來,鹽酸左沙丁胺醇霧化吸入溶液的銷售收入約為人民幣644.68萬元,對比公司最近一期經審計的營業收入,佔比約為0.05%。
沙丁胺醇為短效β2受體激動劑,起效迅速,是目前臨牀上治療哮喘急性發作應用最廣泛的藥物。沙丁胺醇為消旋體,由等量的左旋體和右旋體組成,其中只有左旋體產生舒張支氣管平滑肌的作用,右旋體不僅無治療作用,還易誘發心動過速、低血鉀等不良反應,嚴重者可出現酸中毒。因此,左沙丁胺醇將填補沙丁胺醇的不足,對老人和兒童用藥更有優勢。
同類藥品市場情況:短效β2受體激動劑同類產品還包括吸入用硫酸沙丁胺醇溶液及硫酸特布他林霧化液。根據IQVIA抽樣統計估測數據,國內吸入用硫酸沙丁胺醇溶液2019年度終端銷售金額約為7.41億元,硫酸特布他林霧化液2019年度終端銷售金額約為6.31億元。
此次公司鹽酸左沙丁胺醇霧化吸入溶液被納入《醫保目錄》,將有利於該產品的市場推廣及未來銷售,將對公司的經營業績產生積極影響。因新版《醫保目錄》於2021年3月1日起正式執行,不會對公司本報吿期的經營業績構成重大影響。
根據上海陽光醫藥採購網發佈的《關於開展第四批國家組織藥品集中採購相關藥品信息收集工作的通知》,吸入用硫酸沙丁胺醇溶液即將進入第四批國家組織藥品集中採購,預計可能會對同類藥品的市場份額產生影響。
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