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康恩貝(600572.SH):子公司ES-3000(漢防己甲素)獲美FDA新藥臨牀試驗許可
格隆匯 07-18 16:42

格隆匯7月18日丨康恩貝(600572.SH)公佈,近日,公司控股子公司浙江金華康恩貝生物製藥有限公司(簡稱“金華康恩貝”)通過美國Escend公司收到美國FDA簽發的藥物臨牀試驗許可通知書,同意金華康恩貝產品ES-3000(漢防己甲素)用於治療復發/難治性白血病適應症在美國作為創新藥開展臨牀試驗。

漢防己甲素片(規格:20mg/片)是由金華康恩貝自主研發並生產銷售的產品,批准文號:國藥準字H33022075。漢防己甲素片已被列入我國《國家醫保目錄(2021年版)》,為醫保乙類藥品,根據藥品説明書其適應症為:用於風濕痛、關節痛、神經痛,與小劑量放射合併用於肺癌,亦用於單純硅肺I、II、III期及各期煤矽肺。

金華康恩貝“金艾康”漢防己甲素片為公司大品牌大品種工程產品。2021年國內漢防己甲素片終端市場規模為4.55億元,金華康恩貝“金艾康”漢防己甲素片終端市場規模3.05億元,佔國內漢防己甲素片終端市場份額的67%。金華康恩貝“金艾康”漢防己甲素片的原料由金華康恩貝配套生產使用。

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