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眾生藥業:獲磷酸氯喹片藥品補充申請批件並恢復生產
格隆匯 02-10 19:07

格隆匯2月10日丨眾生藥業(002317.SZ)公佈,公司日前申請公司藥品磷酸氯喹片恢復生產,現已獲得廣東省藥品監督管理局批准簽發的《藥品補充申請批件》,公司完成磷酸氯喹片恢復生產的相關工作。

藥物名稱:磷酸氯喹片;劑型:片劑;規格:0.25g;藥品分類:化學藥品;藥品批准文號:國藥準字H44020906;批件號:粵B202000046;審批結論:為有效防控新型冠狀病毒感染的肺炎疫情,全力支持疫情防控所需藥品的供應保障,同意本品的應急審批和疫情期間的上市生產。本品經省藥檢所檢驗一批產品合格後,方可依據本批件上市生產;請繼續做好本品後續的持續穩定性考察,並制定疫情期間本品上市後風險評估與控制措施。備註:本批件僅在防控新型冠狀病毒感染的肺炎疫情期間內有效。

根據Cell Research報道,國內科學家使用了臨牀分離的2019-nCoV病毒株,在體外評估了包含氯喹和瑞德西韋在內的七種藥物抗病毒感染細胞效果。研究顯示,瑞德西韋和氯喹在低微摩爾濃度便有着良好的抗病毒感染效果及較高的安全係數。氯喹是用於治療瘧疾的“老藥”,在臨牀上已有70多年的使用歷史。公司擁有磷酸氯喹片的生產批件,但多年未生產銷售,在獲悉氯喹對新型冠狀病毒具有一定體外抑制活性後,公司在廣東省藥品監督管理局等相關部門的指導下積極組織磷酸氯喹片的恢復生產工作,並迅速獲得磷酸氯喹片《藥品補充申請批件》。

公司快速響應國家應對新型冠狀病毒感染的肺炎疫情防治所需應急物資生產供應和保障的要求,迅速恢復磷酸氯喹片生產,履行企業社會責任,為疫情防控做出積極貢獻。

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