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廣生堂(300436.SZ):一類抗新冠創新藥泰中定II/III期臨牀研究數據將在國際權威期刊柳葉刀子刊《eClinicalMedicine》發表
格隆匯 03-21 15:52

格隆匯3月21日丨廣生堂(300436.SZ)公佈,公司創新藥控股子公司福建廣生中霖生物科技有限公司(簡稱“廣生中霖”)抗新冠病毒口服小分子3CL蛋白酶抑制劑一類創新藥阿泰特韋片/利托那韋片組合包裝(商品名:泰中定®,英文名:Tazovid®)的註冊臨牀研究數據將發表於國際權威醫學期刊《柳葉刀》旗下子刊《eClinicalMedicine》。

泰中定是公司實施創新發展戰略以來落地的首款獲批上市的創新藥產品,於2023年11月23日附條件批准用於治療輕型、中型新型冠狀病毒感染(COVID19)的成年患者。泰中定在輕型/中型COVID-19患者中開展了一項隨機、雙盲、安慰劑對照II/III期臨牀研究。II/III期臨牀研究結果證實,泰中定可顯著縮短新冠感染患者的臨牀恢復時間2天,治療後第5天病毒載量較基線變化的組間差異為-1.75Log10拷貝/mL),展現超強抗病毒效果。且相比Paxlovid具有更低的劑量(為一半劑量,150mg,BID),也是已上市全球抗新冠創新藥日治療劑量最低的產品,有更優異的安全性,且是目前國內外已獲批上市的新冠治療藥物中唯一在關鍵註冊性臨牀研究中對XBB變異株人羣顯示優異療效且具有統計學差異數據的抗新冠藥物。

《柳葉刀-eClinicalMedicine》期刊在經專業評審專家多輪評審篩選後,正式接受刊出臨牀研究文章全文,是對鍾南山院士、盧洪洲教授(美國院士)作為PI主導的泰中定臨牀研究成果的高度認可,也是對泰中定強效抗病毒,低劑量,優異安全性的充分肯定,將利於泰中定(Tazovid®)國際市場的認可和開發,造福全球新冠患者。

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