中國生物製藥(01177.HK):吸入用氯醋甲膽礆獲藥品註冊證書
格隆匯3月28日丨中國生物製藥(01177.HK)發佈公吿,集團開發的藥物吸入用氯醋甲膽礆(天晴速信)獲得中國國家藥品監督管理局頒發藥品註冊證書。天晴速信按化學藥品3類申報,視同通過仿製藥質量和療效一致性評價,獲批准的適應症:適用無臨牀顯着哮喘的成人和5歲及以上兒童患者的支氣管氣道高反應性診斷,配製成溶液通過霧化吸入給藥。該品種原研產品尚未在國內上市,集團開發的吸入用氯醋甲膽礆成為目前中國唯一獲批用於支氣管激發試驗的激發劑。
氯醋甲膽礆是乙酰膽礆的β-甲基類似物,直接作用於乙酰膽礆受體,引起支氣管平滑肌收縮。臨牀使用吸入用氯醋甲膽礆對氣道反應性進行診斷有助於評估哮喘嚴重程度以及指導治療方案的調整。氯醋甲膽礆得到了國內外權威肺功能檢查診療指南的推薦,作為支氣管激發試驗的工具之一。
此前國內用於激發試驗的氯醋甲膽礆和組織胺等,既沒有作為肺功能測定儀的配套專用試劑獲得批准,也沒有作為藥品獲得批准,相關產品無法在臨牀機構合法使用。天晴速信的獲批上市,可切實解決臨牀急需問題,有助於推動國內哮喘防控的進展。
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