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舒泰神(300204.SZ):BDB-001注射液用於冠狀病毒感染所致相關疾病的治療的臨牀試驗申請獲受理
格隆匯 02-03 15:55

格隆匯2月3日丨舒泰神(300204.SZ)公佈,2020年02月02日,公司及全資子公司北京德豐瑞生物技術有限公司(“德豐瑞”)收到了國家藥品監督管理局行政許可文書《受理通知書》,舒泰神及子公司德豐瑞根據《國家食品藥品監督管理局藥品特別審批程序》申報的關於BDB-001注射液用於治療冠狀病毒感染所致相關疾病的治療的臨牀試驗申請已於2020年01月31日獲得國家藥品監督管理局的受理,受理號為:CXSL2000027國。

藥品名稱:BDB-001注射液;適應症:冠狀病毒可特異性地過度激活補體系統;本品可抑制病毒等因素造成的補體系統激活所致的炎性反應;用於冠狀病毒等感染者的治療:預防肺炎的發生、防止肺炎重症化、降低急性呼吸窘迫綜合徵的發生率。

此次新藥臨牀試驗申請以支持有效疫情防控,保障公眾生命安全與身體健康為初心,後續能否獲得國家藥品監督管理局的批准臨牀試驗、上市尚存在諸多不確定。公司將持續春節假期無休的奮鬥精神,克服疫情當前的多重困難,再接再勵推進上述項目的下一步工作,並按有關規定對該項目後續進展情況及時履行信息披露義務。

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