Ensitrelvir Demonstrates Rapid Antiviral Efficacy Against COVID-19 in Phase 2b Trial
https://www.infectiousdiseaseadvisor.com/home/topics/covid19/ensitrelvir-demonstrates-rapid-antiviral-efficacy-against-covid-19-in-phase-2b-trial/
Ensitrelvir was safe and efficacious against mild to moderate COVID-19, though further studies are needed to assess ensitrelvir among patients with severe disease
公司公告
Shionogi Announces Achievement of the Primary Endpoint for Ensitrelvir Fumaric Acid (S-217622) in the Phase 3 part of the Phase 2/3 Clinical Trial in Asia
https://www.shionogi.com/global/en/news/2022/09/20220928.html
- Ensitrelvir achieved the primary endpoint in the Phase 3 part of the Asian Phase 2/3 clinical trial, demonstrating a significant reduction vs placebo in the time to resolution of five typical Omicron-related symptoms. This study was conducted in a predominantly vaccinated patient population with mild/moderate COVID-19, irrespective of risk factors for severe complications.
- Ensitrelvir also showed a significant reduction in viral RNA on day 4 (following the third dose) relative to placebo (a greater than 1.4 log10 copies/mL vs. placebo for change from baseline on day 4).
- With the results of this study, conducted during the Omicron phase of the pandemic, ensitrelvir has become the first investigational oral antiviral to demonstrate a statistically significant effect compared to placebo in the time to resolution of symptoms.
Xocova® (Ensitrelvir Fumaric Acid) Tablets 125mg Approved in Japan for the Treatment of SARS-CoV-2 Infection, under the Emergency Regulatory Approval System
https://www.shionogi.com/global/en/news/2022/11/e20221122.html
Xocova® is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
附
New COVID-19 oral antiviral approved for use in Japan
https://newatlas.com/health-wellbeing/new-covid-oral-antiviral-approved-japan-ensitrelvir/
上海一家公司己獲得中國銷售權
https://bbs.wenxuecity.com/myhouse/12143159.html
12月23日平安鹽野義在上海商務委、上海經信委的見證下將Ensitrelvir在中國境內的獨家進口權和經銷權授予上海醫藥。12月29日，平安鹽野義又與中國生物製藥附屬正大天晴簽訂中國境內地區的獨家市場推廣協議。
據了解，Ensitrelvir是口服小分子抗病毒藥物，已於2022年11月22日在日本獲得了生產銷售許可，批準其用於治療新冠病毒感染。在鹽野義公布的Ensitrelvir IIb期研究結果中，研究者評估了各組中病毒滴度陽性的患者比例：相比安慰劑組，第四天低劑量組和高劑量組病毒滴度陽性患者比例分別下降了98.1%和94.6%，均達到顯著性差異。日本鹽野義製藥首席執行官手代木功表示，在奧密克戎毒株流行期間，在亞洲針對沒有高血壓等危險因素的廣泛患者實施的2期/3期臨床試驗中，Ensitrelvir確認了其具有優異的抗病毒表現，並針對毒株感染特性的5種症狀均展現出顯著的改善效果。截至目前，平安鹽野義已開始向中國國家藥品監督管理局提交了新藥上市許可申請。
https://www.shionogi.com/global/en/news/2022/12/e20221223.html
