華邦健康(002004.SZ):他達拉非片獲批新增2種規格
格隆匯11月1日丨華邦健康(002004.SZ)公佈,公司全資子公司重慶華邦製藥有限公司(簡稱“華邦製藥”)於近日收到國家藥品監督管理局核准簽發的化學藥品他達拉非片的《藥品補充申請批准通知書》。
他達拉非是一種選擇性、可逆性的磷酸二酯酶5(PDE-5)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(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。
他達拉非與同類機理作用藥物的主要區別為:療效持續時間長達36小時,遠長於同類機理作用藥物3-4小時的療效持續時間,降低了患者在服藥時間方面的顧慮,且不受高脂飲食和酒精攝入的影響。
華邦製藥已於2020年4月獲得他達拉非片(20mg)的藥品註冊批件。此次華邦製藥獲得他達拉非片的《藥品補充批准通知書》,新增5mg、10mg兩個藥品規格。
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