廣生堂(300436.SZ):抗新冠病毒一類創新藥泰中定獲得澳門新藥上市批准
格隆匯1月8日丨廣生堂(300436.SZ)公佈,近日福建廣生堂藥業股份有限公司創新藥控股子公司福建廣生中霖生物科技有限公司的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(項目代號:GST-HG171)/利托那韋片組合包裝(商品名:泰中定®)獲得中國澳門特別行政區政府藥物監督管理局的新藥上市批准並取得成藥登記證書。
泰中定在臨牀前和研究者發起的早期臨牀研究(IIT)中顯示了優於同靶點新冠藥物Paxlovid(P藥)的療效(一項頭對頭比較的研究)。II/III期臨牀研究結果顯示,泰中定具有優異的抗病毒效果,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 copies/mL,是全球已上市同類抗新冠藥物中日治療劑量最低的抗新冠病毒藥物,也是已公開研究數據中降病毒載量最強、轉陰時間最短的同類抗新冠病毒藥物,安全有效。2024年4月,泰中定II/III期臨牀研究數據正式刊登於國際權威醫學期刊《柳葉刀-eClinicalMedicine》。2024年11月泰中定通過國家醫保談判成功納入正式《國家基本醫療保險、工傷保險和生育保險藥品目錄(2024年)》。
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