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兆科眼科-B(06622.HK):國家藥監局受理環孢素眼用凝膠的新藥上市申請

格隆匯5月19日丨兆科眼科-B(06622.HK)宣佈,中國國家藥監局最近受理環孢素眼用凝膠(公司核心產品之一,前稱環孢素A眼凝膠)的新藥上市申請。

透過與國家藥監局就環孢素眼用凝膠進行全面溝通及新藥申請前討論,公司已接獲國家藥監局的書面回覆,同意公司基於先前完成的第III期臨牀試驗(COSMO研究)結果以及對該項臨牀試驗進行的進一步數據挖掘及事後分析提交的新藥申請。

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