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常山藥業(300255.SZ):公司艾本那肽注射液尚未上市銷售
格隆匯 06-09 18:32

格隆匯6月9日丨常山藥業(300255.SZ)公佈股票交易異常波動公吿公司艾本那肽注射液尚未上市銷售。公司艾本那肽注射液用於治療2型糖尿病的上市許可申請已經獲得國家藥監局受理,目前處於專業審評階段,艾本那肽注射液上市審評後續環節仍然較多,艾本那肽最終能否獲批上市及獲批時間仍存在不確定性。治療2型糖尿病藥物種類較多,GLP-1RA為其中之一,且GLP-1RA類藥物也有多款已經上市或在研,即使未來艾本那肽上市,也面臨較高的市場競爭風險,盈利情況存在較大不確定性。

公司艾本那肽注射液擬用於減重適應症的臨牀試驗申請已經獲得國家藥監局受理,目前處於審評階段,能否獲得臨牀試驗批准通知書存在不確定性。艾本那肽即使獲批開展減重適應症臨牀試驗研究,臨牀試驗進度及結果、上市審評結果、未來產品市場競爭形勢均存在諸多不確定性。

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