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海南海藥(000566.SZ):現階段生產的瑞德西韋原料藥和製劑主要為臨牀前期研究和臨牀研究的試驗樣品
格隆匯 02-17 15:17

格隆匯2月17日丨海南海藥(000566.SZ)公佈,公司於2020年2月15日披露了《關於抗病毒藥物研製取得進展的公告》。現對該公告內容涉及的相關事項,公司特別提醒投資者認真注意以下風險因素:

一、瑞德西韋由美國 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、如美國 Gilead 公司開發的瑞德西韋用於新型冠狀病毒肺炎的臨牀試驗成功,獲准在國內上市。公司與國內外合作伙伴研發的瑞德西韋要最終轉化為產品投入市場,仍需符合我國專利法和藥品管理法的有關規定,履行前置專利許可和註冊審批程序,也存在重大不確定性。

三、現階段,公司和國內外合作伙伴生產的瑞德西韋原料藥和製劑主要為臨牀前期研究和臨牀研究的試驗樣品,不會用於投入市場銷售。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。

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