華海藥業(600521.SH):安立生坦片獲藥品註冊批件
格隆匯1月3日丨華海藥業(600521.SH)公佈,公司於近日收到國家藥監局核准簽發的《藥品註冊批件》。
安立生坦片主要用於治療有(世界衞生組織)WHO Ⅱ級或Ⅲ級症狀的肺動脈高壓患者(WHO組1),用以改善運動能力和延緩臨牀惡化。安立生坦片由美國Myogen公司開發,2007年6月在美國批准上市,2010年該產品在中國批准上市。安立生坦片全球主要生產廠商有Sun Pharma、Cipla、Watson Laboratories Inc等,國內生產廠商主要有江蘇豪森藥業集團有限公司和正大天晴藥業集團股份有限公司。據統計,2018年安立生坦片全球市場銷售額約4.6億美元(數據來源於PDB數據庫);2019年前三季度安立生坦片國內等級醫院銷售額約人民幣842萬元(數據來源於鹹達數據庫)。截至目前,公司在安立生坦片研發項目上已投入研發費用約人民幣536萬元。
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