海王生物(000078.SZ):枸櫞酸西地那非片獲批上市
格隆匯2月22日丨海王生物(000078.SZ)公佈,公司控股子公司深圳海王醫藥科技研究院有限公司於近日收到國家藥品監督管理局下發的“枸櫞酸西地那非片”《藥品註冊證書》。此次獲得藥品註冊批件的枸櫞酸西地那非片共有2個規格,分別為50mg、100mg。
枸櫞酸西地那非及其片劑由美國Pfizer公司研製開發,1998年經美國FDA批准首次在美國上市,商品名為偉哥(Viagra),是第一個在美國獲准使用的口服治療男性勃起功能障礙(Erectile Dysfunction,ED)的藥物。輝瑞製藥有限公司生產的枸櫞酸西地那非片於2000年獲我國批准上市。
據米內網統計數據顯示,零售終端是ED類藥物最重要的銷售市場,ED類藥物零售終端的銷售佔比已超過90%,醫院終端不到10%;在中國城市零售藥店終端,枸櫞酸西地那非是泌尿系統化藥TOP1品種,2019年銷售額超過23億元。
枸櫞酸西地那非片獲得藥品註冊證書,視同通過一致性評價,進一步豐富了公司的產品線,有利於提升公司的市場競爭力,擴大產品市場份額。公司目前正積極開展產品生產、銷售的準備工作。
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