Marketing Authorization Application for Luye Pharma's Rivastigmine Multi-Day Transdermal Patch Product Rivalif® under Review at EU Competent Authorities

MISBACH,Germany,May 20,2020 -- Luye Pharma Group announced today that the Marketing Authorization Application (MAA) within the European territory for its Rivastigmine Multi-Day Transdermal Patch (Brand Name: Rivalif®,Product Code: LY30410),an innovative drug delivery system,is under review at European Union Competent Authorities. Rivalif® was developed by Luye Pharma AG,the company's German subsidiary,on its proprietary transdermal patch platform. It will strengthen the Company portfolio in the therapeutic area of central nervous system (CNS).

The MAA for Rivalif®is based on decentralized procedure under Article 10 (3) of Directive 2001/83/ EC ("hybrid application"),with Germany as the Reference Member State,and has been formally accepted for review by Germany's Federal Institute for Drugs and Medical Devices (BfArM) on May 15th.

Alzheimer's disease remains a major health issue in modern society,with the number of patients constantly growing. According to World Alzheimer Report 2018,there is a new case of dementia in the world every three seconds.50 million people worldwide were living with dementia in 2018,and this number is expected to reach 152 million by 2050[1]. Rivastigmine remains to be a first-line drug in the treatment of dementia associated with Alzheimer in that therapeutic field.

Rivalif®,as a twice-weekly patch,has the potential to reduce the burden for patients and caregivers with more convenient posology having longer interval between dosing and to improve patients' medication adherence. As transdermaladministration,it is convenient for patients who have difficulty in swallowing,and has lower incidence of gastrointestinal adverse reactions such as nausea and vomiting compared with the oral form. Luye has filed and been issued a portfolio of international patents protecting Rivalif®.

The company's German-based subsidiary,Luye Pharma AG,is one of the largest independent transdermal patch developers and manufacturers in Europe. The company's previous once-daily patch of Rivastigmine hasbeen successfully launched in over 20 countries around the world,and is currently under registration in China.

Dr. Youxin Li,Global R&D President of Luye Pharma Group said: "This is a very important milestone in our journey to provide innovative products addressing unmet needs and we look forward,to bring this new therapy to patients with Alzheimer's disease soon. Beside Europe,Luye Pharma plans to develop the product also for China. We will also continue to expand our CNS portfolio and further improve our global competitiveness in this therapeutic field."

CNS is one of the key therapeutic areas for Luye Pharma. Currently the company has a number of projects relating to CNS which are under concurrent development,including depression,Parkinson's disease,schizophrenia,bipolar disorder,and Alzheimer's disease. The company is accelerating the development and commercialization preparation of these new drugs,hoping to allow as many patients as possible to benefit from them,all around the world.

[1] https://www.alz.co.uk/research/WorldAlzheimerReport2018.pdf