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東陽光藥(01558.HK):男性勃起功能障礙治療產品他達拉非片獲批准上市
格隆匯 12-14 16:45

格隆匯 12 月 14日丨東陽光藥(01558.HK)發佈公告,公司從廣東東陽光藥業有限公司收購的產品他達拉非片(2.5mg、5mg、10mg及20mg)已獲中國國家藥品監督管理局審批完畢並獲准上市。後續通過補充申請,該產品的上市許可持有人將變更為公司或公司的控股子公司。

他達拉非用於治療男性勃起功能障礙(ED,Erectile Dysfunction),勃起功能障礙(ED)合併良性前列腺增生(BPH , Benign Prostatic Hyperplasia)的症狀和體徵;是環磷酸鳥苷(cGMP)特異性磷酸二酯酶5(PDE5)的選擇性可逆抑制劑。公司他達拉非片按照中國藥品註冊分類化學藥品4類申報,根據艾美仕數據顯示,2019年中國他達拉非片藥物銷售金額約為4780萬美元。

該產品具有良好的臨牀應用價值和市場前景,上市後將成為公司在泌尿系統治療領域的產品的一,在進一步豐富集團的產品組合的同時,也為廣大患者提供質價雙優的用藥選擇。

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