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/
上海一家公司己获得中国销售权
https://bbs.wenxuecity.com/myhouse/12143159.html
12月23日平安盐野义在上海商务委、上海经信委的见证下将Ensitrelvir在中国境内的独家进口权和经销权授予上海医药。12月29日，平安盐野义又与中国生物制药附属正大天晴签订中国境内地区的独家市场推广协议。
据了解，Ensitrelvir是口服小分子抗病毒药物，已于2022年11月22日在日本获得了生产销售许可，批准其用于治疗新冠病毒感染。在盐野义公布的Ensitrelvir IIb期研究结果中，研究者评估了各组中病毒滴度阳性的患者比例：相比安慰剂组，第四天低剂量组和高剂量组病毒滴度阳性患者比例分别下降了98.1%和94.6%，均达到显著性差异。日本盐野义制药首席执行官手代木功表示，在奥密克戎毒株流行期间，在亚洲针对没有高血压等危险因素的广泛患者实施的2期/3期临床试验中，Ensitrelvir确认了其具有优异的抗病毒表现，并针对毒株感染特性的5种症状均展现出显著的改善效果。截至目前，平安盐野义已开始向中国国家药品监督管理局提交了新药上市许可申请。
https://www.shionogi.com/global/en/news/2022/12/e20221223.html
