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博瑞醫藥:成功仿製抗病毒藥物 瑞德西韋製劑批量化生產正在進行中
格隆匯 02-11 21:46

格隆匯2月11日丨博瑞醫藥(688166.SH)公佈,公司積極響應國家抗擊新型冠狀病毒(2019-nCoV)疫情的號召,於近日成功仿製開發了瑞德西韋原料藥合成工藝技術和製劑技術。公司已經批量生產出瑞德西韋原料藥,瑞德西韋製劑批量化生產正在進行中。

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,目前瑞德西韋用於新型冠狀病毒(2019-nCoV)感染的Ⅲ期臨牀試驗並未結束,因此該藥物對於新型冠狀病毒(2019-nCoV)感染是否有效存在重大不確定性。如果相關臨牀試驗結果不理想,則瑞德西韋的仿製技術就無重大價值可言。

如果新型冠狀病毒(2019-nCoV)感染造成的疫情短期內迅速獲得控制和緩解,確診病人持續減少,即使瑞德西韋獲得註冊批准,用於治療新型冠狀病毒(2019-nCoV)感染,預計也不會對抗擊本次疫情有重大幫助。

即使瑞德西韋用於新型冠狀病毒(2019-nCoV)感染的臨牀試驗成功,公司的前述研發要最終轉化為產品投入市場,仍需經過獲得專利權人美國Gilead公司授權、藥物臨牀、藥品審批等多個環節,這一過程將存在重大不確定性。

公司將對瑞德西韋的仿製研發視為自身所承擔的社會責任,若該產品能夠獲批上市,疫情期間主要通過捐贈等方式供應給相關病人。因此,從生產成本、定價、銷量預期等方面考慮,預計該產品不會對公司2020年的經營業績產生重大影響。

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