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長春高新(000661.SZ):伏欣奇拜單抗注射液臨牀試驗申請獲得批准
格隆匯 04-28 17:44

格隆匯4月28日丨長春高新(000661.SZ)公佈,近日,公司控股子公司——長春金賽藥業有限責任公司(以下簡稱"金賽藥業")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》,金賽藥業伏欣奇拜單抗注射液的境內生產藥品註冊臨牀試驗申請獲得批准。

產品名稱:伏欣奇拜單抗注射液

申請事項:境內生產藥品註冊臨牀試驗

受理號:CXSL2500163

申請人:長春金賽藥業有限責任公司

審批結論:經審查,同意本品開展臨牀試驗

適應症:子宮內膜異位症

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