科倫藥業(002422.SZ):溴莫尼定噻嗎洛爾滴眼液國內首仿獲批
格隆匯9月25日丨科倫藥業(002422.SZ)公佈,公司子公司江西科倫藥業有限公司的化學藥品“溴莫尼定噻嗎洛爾滴眼液”於近日獲得國家藥品監督管理局的藥品註冊批准。
溴莫尼定噻嗎洛爾滴眼液為艾爾健研發的複方滴眼劑,2005年在英國首獲批,後相繼在美國、日本等多個國家上市,2014年於國內批准進口,用於降低成人開角型青光眼或高眼壓症患者升高的眼壓。
降低眼壓為唯一經過循證醫學證實的青光眼有效治療方法,真實臨牀常需聯合不同機制藥物協同增效。溴莫尼定為目前唯一顯示具有降眼壓和視神經保護雙重作用的藥物,聯合噻嗎洛爾將進一步增加降眼壓療效,且複方製劑可減少給藥頻率和防腐劑累積,提高用藥依從性。溴莫尼定噻嗎洛爾滴眼液目前已被中國《中國青光眼指南(2020)》、美國《原發性開角型青光眼(2020)》、歐洲《青光眼術語和指南(2021)》等國內外權威指南推薦,2021年全球銷售額5.3億美元。
公司溴莫尼定噻嗎洛爾滴眼液為國內首仿獲批,上市後將為國內青光眼患者提供兼具降眼壓和視神經保護雙重功效的藥物選擇。目前公司眼科管線已有14個產品獲批,已基本形成針對青光眼、乾眼症、結膜炎等常見眼科疾病的有效解決方案。
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