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科倫藥業(002422.SZ):唑來膦酸注射液為科倫首個獲批進入骨質疏鬆領域的藥物
格隆匯 11-25 16:22

格隆匯 11 月 25日丨科倫藥業(002422.SZ)公佈,公司於近日獲得國家藥品監督管理局核准簽發的化學藥品唑來膦酸注射液的《藥品補充申請批准通知書》。

近日公司的唑來膦酸注射液通過一致性評價並獲得藥品補充申請批准通知書,用於治療絕經後婦女與成年男性的骨質疏鬆症。

唑來膦酸注射液為第三代雙膦酸鹽類骨吸收抑制劑,較第一、二代能夠明顯提高骨密度、降低椎體和髖部骨折發生的風險,為目前全球唯一可每年給藥一次的骨質疏鬆治療藥物。已被《美國臨牀內分泌醫師學會/美國內分泌學院(AACE/ACE)臨牀實踐指南:絕經後骨質疏鬆症的診斷和治療(2020年)》、絕經期和絕經後婦女骨質疏鬆防治專家共識(2020)》、《男性骨質疏鬆症診療指南(2020)》等國內外權威指南和專家共識廣泛推薦用於多種不同類型骨質疏鬆的治療。唑來膦酸注射液為2019版國家醫保目錄品種2019年中國銷售額9.2億元

唑來膦酸注射液為科倫首個獲批進入骨質疏鬆領域的藥物,此次公司國內首家通過一致性評價,將進一步提升該品種的市場競爭力。

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