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景峯醫藥(000908.SZ):參股公司重組人截短型纖溶酶注射液項目獲臨牀試驗默示許可
格隆匯 11-26 11:53

格隆匯11月26日丨景峯醫藥(000908.SZ)公佈,根據國家藥品監督管理局於2018年12月4日發佈的《關於藥審中心網站開通臨牀默示許可相關功能的通知》,國家藥品監督管理局“臨牀試驗默示許可”模塊可查詢已獲得“臨牀試驗默示許可”品種的基本信息。近日經查詢,公司的參股公司江蘇璟澤生物醫藥有限公司、上海景澤生物技術有限公司與成都澤研生物技術有限公司聯合提交的重組人截短型纖溶酶注射液項目獲得臨牀試驗默示許可。

此次獲得臨牀試驗默示許可的藥品為重組人截短型纖溶酶注射液,主要為治療症狀性玻璃體黃斑黏連,該項目主要研發產品為治療症狀性玻璃體黃斑黏連的眼底注射製劑,可用於替代玻璃體剝離手術治療。據國家藥品監督管理局《關於藥審中心網站開通臨牀默示許可相關功能的通知》,申請人後續需使用數字證書進行身份認證後下載《臨牀試驗通知書》。

公司獲得上述藥品臨牀試驗默示許可後,將按國家臨牀試驗的要求組織開展臨牀試驗並申請註冊批件。

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