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億帆醫藥(002019.SZ):在研產品F-652新增適應症慢加急性肝衰竭獲批開展II期臨牀試驗
格隆匯 09-07 20:07

格隆匯9月7日丨億帆醫藥(002019.SZ)公佈,公司控股子公司億一生物醫藥開發(上海)有限公司(上海億一)202197收到國家藥品監督管理局核准簽發的藥物臨牀試驗批准通知書》,同意上海億一在研產品重組人白介素22-Fc融合蛋白(F-652)新增適應症慢加急性肝衰竭開展II臨牀試驗

審批結論: 根據《中華人民共和國藥品管理法》及有關規定,經審查,2021622日受理的注射用重組人白介素22-Fc融合蛋白符合藥品註冊的有關要求,同意開展臨牀試驗。

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