中生製藥(01177.HK)支氣管藥獲藥品註冊證書
中生製藥(01177.HK)公佈,集團開發的藥物「吸入用氯醋甲膽礆」(天晴速信)獲得中國國家藥監局頒發藥品註冊證書。
該產品按化學藥品3類申報,視同通過仿製藥質量和療效一致性評價,獲批準的適應症爲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。
中生製藥表示,該品種原研產品尚未在境內上市,集團開發的吸入用氯醋甲膽礆成爲目前中國唯一獲批用於支氣管激發試驗的激發劑。
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