$中欣氟材(SZ002915)$ 日本盐野义：新冠口服药Xocova可缩短无症状或轻度感染者转阴时间

共同社4月5日消息，日本盐野义制药公司5日就新冠口服药Xocova称，仅针对无症状或轻度症状感染者实施的临床试验中，确认具有把转为阴性的时间缩短约一天的效果。

服用安慰剂的小组转阴需要66.7个小时，而服用Xocova的小组为38.3个小时。盐野义另外确认，服用第四天时病毒量减少。该公司称，服用Xocova还降低从无症状到发病者的比例、从轻度症状到恶化者的比例。

Shionogi Receives U.S. FDA Fast Track Designation for Ensitrelvir Fumaric Acid, an Investigational Oral Antiviral for COVID-19

OSAKA, Japan, April 4, 2023 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for their investigational COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”). FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfill an unmet medical need.

Ensitrelvir, known as Xocova® 125 mg tablet in Japan, recently received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the treatment of SARS-CoV-2 infection. It remains an investigational drug outside Japan.

COVID-19 is a serious and potentially life-threatening illness.1 As of mid-January 2023, over 660 million cases have been reported globally, with more than 101 million cases of COVID-19 in the United States.2