羅欣藥業(002793.SZ):他達拉非片獲批上市
格隆匯 2 月 8日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司山東羅欣藥業集團股份有限公司(“山東羅欣”)於近日收到國家藥品監督管理局核准簽發的他達拉非片《藥品註冊證書》。
他達拉非是一種選擇性、可逆性的磷酸二酯酶5(PDE5)抑制劑。該產品用於解決男性勃起功能障礙問題,具有起效快,安全性高,藥效持續時間長的特點,且不受高脂飲食和酒精攝入的影響。
他達拉非最早由美國禮來公司研製開發,分別於2002年11月12日、2003年11月21日和2007年7月31日在歐盟、美國和日本獲批,商品名為Cialis®,規格為2.5mg、5mg、10mg和20mg,並於2004年12月28日在國內獲批上市,適應症為用於治療勃起功能障礙(ED,Erectile Dysfunction),2019年5月新增治療勃起功能障礙(ED)合併良性前列腺增生(BPH,Benign ProstaticHyperplasia)的症狀和體徵的適應症。
山東羅欣於2016年1月獲得他達拉非片臨牀試驗批件,2018年8月完成生物等效性試驗,於2019年1月向國家藥品監督管理局藥品審評中心按照化學藥品新註冊分類4類進行申報並獲得受理。
根據IQVIA數據,他達拉非片2019年度在全球的銷售金額為6.2億美元(以出廠價計算),在我國境內醫院市場銷售金額為1.0億元人民幣(以招標價計算),零售市場為3.7億元人民幣。
他達拉非片為公司的首個男科用藥,適應症方面除了獲批用於治療 ED以外,還獲批了原研新批准的ED合併BPH的適應症,且同時獲批三個規格,使得患者在選擇ED治療解決方案時更加靈活。
他達拉非片獲得藥品註冊批件,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,對公司產生積極影響。公司將根據市場需求情況,着手安排生產銷售。
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