華邦健康(002004.SZ):他達拉非片獲藥品註冊批件
格隆匯4月21日丨華邦健康(002004.SZ)公佈,公司全資子公司華邦製藥於近日獲得國家藥品監督管理局核准簽發的化學藥品他達拉非片的《藥品註冊批件》。他達拉非是一種選擇性、可逆性的磷酸二酯酶5(PDE5)抑制劑,適應症為勃起功能障礙(ED),另外還有前列腺增生和肺動脈高壓兩個可增加的適應症。
他達拉非為美國禮來原研藥物,2004年作為治療男性勃起功能障礙(ED)的藥物在美國上市,商品名為“CIALIS”(希愛力),並於2005年在國內獲批上市。此後,禮來公司又向FDA申請了關於治療肺動脈高壓(PAH)和治療良性前列腺增生(BPH)的兩項適應症,並獲得批准。
據米內網數據顯示,2018年他達拉非在中國城市公立醫院銷售額為1.19億元,在中國城市零售藥店終端銷售額為6.08億元。
公司表示,華邦製藥獲得他達拉非片藥品註冊批件,視同通過一致性評價,進一步豐富了公司產品管線,拓展了公司產品治療領域,對進一步優化公司產品結構、探索新的營銷模式均有積極意義。隨着該產品市場佔有率的逐步增加,對公司業績的提升將產生積極影響。
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