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兆科眼科-B(06622.HK):獲藥審中心受理評審於中國進行NVK-002第III期臨牀試驗的新藥試驗申請
格隆匯 07-15 17:59

格隆匯7月15日丨兆科眼科-B(06622.HK)宣佈,於2021年7月14日,於中國開展NVK-002第III期臨牀試驗的新藥臨牀試驗申請已獲中國國家藥監局藥品審評中心("藥審中心")受理評審。

公司夥伴Vyluma Inc.("Vyluma",NevakarInc.("Nevakar")的全資附屬公司,於2021年5月成立)於歐美進行的NVK-002第III期臨牀試驗(CHAMP)乃全球最先進的藥品註冊研究,以低劑量阿托品緩減兒童及青少年的近視加深。三年期NVK002治療的CHAMP試驗預計於2022年底前完成。預期於2023年向美國食品藥品監督管理局("FDA")提交新藥上市申請,而NVK-002現時的定位為全球首個緩減近視加深的認可產品。假若於美國取得FDA認可,則該藥亦將合資格於中國海南省進行真實世界研究。此外,全球CHAMP研究的數據將與公司的中國臨牀試驗數據合併,以支持向國家藥監局作出的NVK-002新藥申請。

根據世界衞生組織及灼識行業諮詢有限公司,中國目前有約7億名近視患者,當中1.63億為或能受惠於NVK-002的兒童及青少年。董事會相信,NVK002的潛在商業生產將讓公司藉滿足中國龐大的需求缺口,建立領導地位。

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