Eisai has received regulatory approval in China for its anti-insomnia medicine DAYVIGO® (lemborexant).

卫材的抗失眠药物DAYVIGO®（lemborexant）已获得中国监管机构的批准。

DAYVIGO is a dual orexin receptor antagonist. It blocks orexin signals in the brain, which are central to the sleep-wake cycle. By competitively binding to both orexin receptor subtypes (OX1R and OX2R)—with a stronger effect on OX2R—the medicine improves both sleep onset and maintenance by dampening wakefulness signals affecting REM and non-REM sleep..

DAYVIGO是一种双重食欲素受体拮抗剂。它阻断大脑中的食欲素信号，这些信号是睡眠-觉醒周期的核心。通过竞争性结合两种食欲素受体亚型（OX1R和OX2R），并对OX2R具有更强的效果，该药物通过抑制影响REM和非REM睡眠的觉醒信号，改善了睡眠的开始和维持。

Insomnia is defined as difficulty in falling or staying asleep at least three times a week for a month or more, despite adequate opportunity for rest. It can lead to fatigue, poor concentration and irritability. In China, about 15 per cent of adults—an estimated 172.5 million people—are thought to experience the condition..

失眠的定义是尽管有充足的休息机会，但每周至少三次，持续一个月或更长时间难以入睡或保持睡眠。它可能导致疲劳、注意力不集中和易怒。在中国，大约15%的成年人（估计有1.725亿人）被认为患有这种症状。

This marks the entry of the company’s in-house-developed drug into the Chinese market for treating adults with insomnia.

这标志着该公司自主研发的药物进入中国市场，用于治疗成人失眠症。

The application for approval drew on data from three Phase 3 studies. Two global trials, SUNRISE 1 and SUNRISE 2, involved roughly 2,000 adults with insomnia. A third trial, Study 311, assessed the drug’s safety and efficacy in a Chinese population.

该审批申请基于三项 III 期研究的数据。其中两项全球性试验 SUNRISE 1 和 SUNRISE 2 涉及大约 2000 名成年失眠患者。第三项试验 Study 311 评估了该药物在中国人群中的安全性和有效性。

With approvals now in 23 countries and regions, including Japan, the United States, Canada and Australia, Eisai aims to offer DAYVIGO as a new option for people with insomnia worldwide and to support better sleep quality and daytime function.

包括日本、美国、加拿大和澳大利亚在内的23个国家和地区现已批准，卫材旨在将DAYVIGO作为全球失眠患者的新选择，并支持更好的睡眠质量和日间功能。

Source: eisai.com

来源：eisai.com