Luye Pharma Group has announced that Towa Pharmaceutical Co., Ltd. (Towa) has filed a New Drug Application (NDA) with Japan's Ministry of Health, Labour and Welfare (MHLW) for the Rivastigmine Twice Weekly Transdermal Patch, designed for treating mild to moderate dementia associated with Alzheimer’s disease.This drug, developed using Luye Pharma's proprietary transdermal patch platform, utilizes an innovative delivery system to administer rivastigmine transdermally twice a week.

Luye Pharma Group宣布，Towa Pharmaceutical Co.，Ltd.（Towa）已向日本厚生劳动省（MHLW）提交了一份新药申请（NDA），用于每周一次两次的利凡斯的明透皮贴剂，旨在治疗与阿尔茨海默氏病相关的轻度至中度痴呆症。该药物使用Luye Pharma专有的透皮贴剂平台开发，利用创新的递送系统每周两次透皮给药卡巴拉汀。

In December 2020, Luye Pharma granted Towa an exclusive license for the development and commercialization of this drug in Japan.Towa's NDA submission is based on interim results from a Phase 3 clinical trial in Japan, which met the primary efficacy endpoint for patients with Alzheimer’s-related dementia.Alzheimer's disease, a neurodegenerative condition that leads to progressive cognitive decline, is the most common form of dementia, accounting for 50%-75% of all cases.

2020年12月，Luye Pharma授予Towa在日本开发和商业化该药物的独家许可证。Towa提交的NDA是基于日本3期临床试验的中期结果，该试验符合阿尔茨海默病相关痴呆患者的主要疗效终点。阿尔茨海默病是一种导致进行性认知能力下降的神经退行性疾病，是痴呆症最常见的形式，占所有病例的50%-75%。

As of 2023, 29.1% of Japan’s 125 million population was aged 65 or older, according to the Ministry of Internal Affairs and Communications. Studies show that more than 50% of the elderly in Japan have a lifetime risk of developing dementia, with over half of these cases being Alzheimer’s disease.Since managing medication can be an early challenge for those with Alzheimer’s, orally disintegrating tablets and patches have been suggested to improve adherence.

根据内务和交通部的数据，截至2023年，日本1.25亿人口中有29.1%的人年龄在65岁或以上。研究表明，日本超过50%的老年人一生都有患痴呆症的风险，其中一半以上是阿尔茨海默病。由于管理药物可能是阿尔茨海默病患者的早期挑战，因此建议使用口腔崩解片和贴片来提高依从性。

The Rivastigmine Twice Weekly Transdermal Patch, which requires less frequent administration than the typical once-daily patches, aims to enhance medication adherence.Kiyoshi Kaneko, President of Luye Life Sciences Japan and head of Luye Pharma Japan, stated: “There is a significant unmet need for effective treatments for dementia associated with Alzheimer’s disease in Japan.

利凡斯的明每周两次透皮贴剂需要比典型的每日一次贴剂更少的频率，旨在增强药物依从性。Luye Life Sciences Japan总裁兼Luye Pharma Japan负责人Kiyoshi Kaneko表示：“日本对与阿尔茨海默病相关的痴呆症的有效治疗需求尚未得到满足。

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