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興齊眼藥(300573.SZ):SQ-22031滴眼液獲得臨牀試驗批准通知書
格隆匯 07-25 20:37

格隆匯7月25日丨興齊眼藥(300573.SZ)公佈,近日,公司收到國家藥品監督管理局簽發的關於SQ-22031滴眼液的《藥物臨牀試驗批准通知書》。

SQ-22031滴眼液為我公司研發的1類治療用生物製品。臨牀擬用於(1)乾眼症;(2)神經營養性角膜炎。其中適應症(2)神經營養性角膜炎,於2023年被列入我國第二批罕見病目錄。根據生物製品註冊分類中對1類治療用生物製品的有關要求,公司已經完成SQ-22031滴眼液藥學及非臨牀藥理毒理學等多方面的研究,研究結果表明SQ-22031滴眼液具有良好的安全性及臨牀開發價值。

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