華潤醫藥(03320.HK)旗下華潤賽科賽洛多辛膠囊獲得藥品註冊證書及通過一致性評價
華潤醫藥(03320.HK)公佈,集團旗下華潤賽科獲得國家藥品監督管理局頒發的賽洛多辛膠囊《藥品註冊證書》(證書編號:2023S00742)。根據國家相關政策規定,是次獲得《藥品註冊證書》視同通過一致性評價。
賽洛多辛膠囊適用於治療良性前列腺增生症(BPH)引起的症狀和體徵。賽洛多辛膠囊最早於2008年10月在美國獲批,商品名爲「RAPAFLO」,並於2011年8月在中國批準上市。根據全球71國家藥品銷售數據庫顯示,2021年賽洛多辛膠囊全球銷售額2.1億美元,「RAPAFLO」全球銷售額0.12億美元。根據米內網數據顯示,2022年國內醫療市場賽洛多辛膠囊銷售總額(終端價)爲8,520萬元人民幣。
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