海南海藥(000566.SZ):已完成瑞德西韋製劑第一批生產
格隆匯2月14日丨海南海藥(000566.SZ)公佈,公司積極響應國家抗擊新型冠狀病毒(2019-nCoV)感染疫情的號召,通過與國內外合作伙伴的緊密合作,已經完成瑞德西韋原料藥及製劑工藝研發。公司已經完成瑞德西韋製劑的第一批生產,並已具備年產350萬支的規模化生產能力。
(一)瑞德西韋由美國GileadSciences,Inc.(以下簡稱“Gilead公司”)開發,用於防治埃博拉病毒感染,已經在國外通過了Ⅰ期和Ⅱ期臨牀試驗。體外和活體動物試驗表明,該藥品對多種冠狀病毒有效,個別臨牀病例有效。瑞德西韋已在中國開展的新型冠狀病毒(2019-nCoV)感染的Ⅲ期臨牀試驗尚未揭盲。因此,瑞德西韋對於新型冠狀病毒(2019-nCoV)人體感染的治療是否有效存在重大不確定性。
(二)公司關於瑞德西韋用於新型冠狀病毒(2019-nCoV)的研發最終能否轉化為產品投入市場,需經過獲得專利權人Gilead公司授權、藥品審批等多個環節,這一過程將存在重大不確定性。
(三)即使該產品能夠獲批上市,預計該產品不會對公司2020年經營業績產生重大影響。敬請廣大投資者理性投資,注意風險。
公司通過與國內外合作伙伴的緊密合作,已進行瑞德西韋製劑的中試生產,可批量生產瑞德西韋50mg、100mg兩種劑型。目前,公司已具備規模化批量生產能力,瑞德西韋製劑(50mg/支、100mg/支)年產能可達350萬支。公司可以根據國家的安排和社會的需要,在符合相關法律法規的前提下隨時安排生產。
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