COVID-19：Shionogi，新冠药物批准申请：S-217622
盐野木：
2月25日，
我们向厚生劳动省申请制造和销售一种新型冠状病毒药物。
申请生产和销售许可：
基于临床试验/中间分析数据的实际使用。
实行“有条件提前审批制”。
如果获批，将成为国内首家为轻中度患者用药的公司。
S-217622（开发号）：
候选药物“S-217622（开发编号）”干扰病毒生长所需的酶的作用。
在感染的早期阶段每天服用一次，连续 5 天。
终期临床试验：
自 2021 年 9 月以来一直在进行的最后阶段临床试验。
参加者的目标是约2000人。
Shionogi 分析了其中大约 400 个的结果。
3剂后：
减少病毒量：
证实能够感染的病毒量显着减少。
呼吸道症状评分：
据说喉咙痛和咳嗽等呼吸道症状的评分有所改善。
没有发现重大的安全问题。
也适用于 Omicron 类型：
在实验室水平分析中，该药物对突变体“Omicron”也有效。
未来供应系统：
Shionogi 自 2009 年 12 月以来一直与开发并行生产。
到3月底，它将产生100万人。
从4月份开始，我们建立了每年1000万人的供应体系。
日本经济新闻
https://www.nikkei.com/article/DGXZQOUF251JX0V20C22A2000000/
Shionogi applies for approval of oral COVID-19 medication
On Friday, Shionogi said the drug was found to be highly effective in a mid-stage clinical trial,
which was carried out mainly when cases of the Omicron variant were growing.
The firm says
the study covered 428 coronavirus patients aged 12 or older with mild to moderate symptoms within five days after they tested positive.A five-day course of one daily dose was compared with a placebo.
Shionogi says that after the third dose,
less than 10 percent of the subjects given the drug had an infectious viral load — lower than in the placebo group.
It adds that significant improvements
were seen in respiratory symptoms, such as a stuffy or runny nose, sore throat, coughing and shortness of breath.
It says no serious side effects were observed.
Shionogi says final-stage trials involving around 2,000 people are ongoing.
But it says it filed for “conditional early approval” of the medication in Japan
ahead of other countries following the results of the mid-stage trial.
Two other oral medications for mild COVID-19 have been authorized in Japan.
Both were developed by foreign pharmaceutical firms.
Shionogi says that by the end of March,
it plans to manufacture enough for one million people, and from April, enough for more than 10 million people annually.
NHK WORLD-JAPAN News