兆科眼科-B(06622.HK):貝美素噻嗎洛爾滴眼液(晶貝瑩®)獲批上市
格隆匯2月20日丨兆科眼科-B(06622.HK)宣佈,由公司研發生產的抗青光眼藥物貝美素噻嗎洛爾滴眼液(晶貝瑩®)獲得國家藥品監督管理局(NMPA)批准上市,用於降低對β-受體阻滯劑或前列腺素類似物治療效果不佳的原發性開角型青光眼及高眼壓症患者的眼壓。
貝美素噻嗎洛爾滴眼液(晶貝瑩®)是中國首個用於治療青光眼╱高眼壓症的貝美素噻嗎洛爾滴眼液仿製藥。該產品生產線符合GMP符合性檢查,已通過一致性評價。
貝美素噻嗎洛爾滴眼液為複方製劑,其組份為貝美前列素和馬來酸噻嗎洛爾,通過增加房水經葡萄膜鞏膜及小梁網途徑的外流和減少睫狀體房水的生成的三重途徑降低眼內壓,與其它複方製劑相比,具有強效降眼壓、治療後眼壓更平穩的優勢。此外,與單藥╱組分藥物同時治療相比,貝美素噻嗎洛爾滴眼液組結膜充血不良反應率顯着更低。
貝美素噻嗎洛爾滴眼液的獲批上市標誌着公司在青光眼藥物治療領域取得了重大進展,為公司的青光眼產品組合(目前包括合共七種藥物及一款家用眼壓測量儀器)開啟新篇。
貝美素噻嗎洛爾滴眼液是公司第一款獲藥監局批准的仿製藥物,也標誌着公司正式步入管線產品商業化階段。
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