聯環藥業(600513.SH):收到鹽酸達泊西汀片的藥品註冊證書
格隆匯12月23日丨聯環藥業(600513.SH)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥品註冊證書》,該藥品名稱為鹽酸達泊西汀片。
公司鹽酸達泊西汀片使用的鹽酸達泊西汀原料藥由公司生產,鹽酸達泊西汀原料藥已於2020年4月1日獲得國家藥品監督管理局藥品審評中心公示登記,此次鹽酸達泊西汀片獲得註冊批准,公司鹽酸達泊西汀原料藥在國家藥品監督管理局藥品審評中心原料藥、藥用輔料和藥包材登記信息公示“與製劑共同審批結果”為A。
鹽酸達泊西汀片是一種選擇性5-羥色胺再吸收抑制劑,用於治療成年男性早泄(PE)。目前國內鹽酸達泊西汀片生產廠家主要有:山東朗諾製藥有限公司、揚子江藥業集團江蘇紫龍藥業有限公司、廈門力卓藥業有限公司等6家。2020年國內樣本醫院鹽酸達泊西汀片銷售額約668.83萬元(數據來源於PDB數據庫)。
2020年,公司首次遞交本品註冊申請並獲受理(受理號:CYHS2000273),近日,公司收到國家藥監局核准簽發的鹽酸達泊西汀片《藥品註冊證書》。公司本次鹽酸達泊西汀片按照化藥註冊4類進行申報,根據國家相關政策,本次獲得藥品註冊證書視同通過一致性評價。
截至目前,公司鹽酸達泊西汀及片項目累計已投入研發費用約人民幣1055.63萬元(未經審計)。
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