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兆科眼科-B(6622.HK)治療近視新藥獲藥監局批准臨牀試驗
格隆匯 09-29 11:28
格隆匯9月29日丨兆科眼科宣佈,有關在中國開展NVK-002為期2年的第III期臨牀試驗(針對近視加深的兒童阿托品研究,又稱China CHAMP研究),以及為期1年的第III期橋接臨牀試驗(小型CHAMP)提交的新藥臨牀試驗申請,已於9月27日獲國家藥監局藥審中心批准。第III期臨牀試驗的主要目標為評估NVK-002對控制3至17歲兒童及青少年近視加深的療效及安全性。NVK-002是一種有可能用於控制兒童及青少年近視加深的新型外用眼部溶液。為期3年的NVK-002試驗預計於2022年年底前完成,並預期於2023年向美國FDA提交新藥上市申請。最快於2024年在中國市場推出,助力兆科眼科成為全球首間在中國市場推出用於治療近視藥物的公司。
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