Rivalif, a new drug for green leafy drug Alzheimer's disease, has been accepted by the European Union

May 18, Greenlee Pharmaceuticals announced that its innovative drug for Alzheimer's disease, Liss's Mindo Day permeable patch (product name Rivalif
®
, product number LY30410), had been accepted by EU authorities. Developed by its German subsidiary, Luye Pharma AG, the drug is a core product of the Group in the field of central neurotherapy.
The listing application is based on a non-centralized review process under Article 10 (3) of Directive 2001/83/EC, with the German Federal Institute of Medicines and Medical Devices (BfArM) as its reference member. The listing application has been formally verified and the approval process has been initiated. Clinical trials have been discussed during the development phase with the European Medicines Agency (EMA) and BfArM and form the basis of the listing application.
Two clinical trials were considered critical, the first being an open, randomized, two-cycle, two-sequence cross-study to assess the biological ewes of the group's Mindo Day Patch and reference agent Exelon
®
(one-day patch) in a stable state under the 9.5mg/24h specification. The second key trial was designed to test a comparison between Liss's mindfulness patch and Exelon
®
's patch adhesion and skin irritation in older subjects aged 55 to 90 (target population). Both clinical trials met the end point set by the program.Liss's Mindo Day Patch is a postcard form developed by the group twice a week. The product was developed by the company's subsidiary, Luye Pharma AG (Green Leaf Germany), on a permeable patch research and development platform for key products for central nervous system diseases. Leafy Germany has developed Liss's single-day patch for the U.S. and European markets and has a good track record of successful product development.Compared with the commercially available Liss's single-day patch, Lis's Mingdo-day patch has a lower frequency of use, which can improve the patient's drug compliance. The product and its preparation process are protected globally by multiple patents. In addition to Germany, the Company is also prepared to register the product in other European countries, China, the United States, Japan and other countries.In addition to Liss's Multi-Day Patch, the Group also has a number of central nervous system research projects, simultaneously developed in China and overseas markets, such as LY 03004 (on schizophrenia and bipolar disorder) that has been submitted to NDA in China and the United States and approved for listing in the United States (PAI), Projects such as LY 03003 (about Parkinson's disease), LY 03005 (about depression), LY 03010 (on the treatment of schizophrenia and schizophrenic emotional disorder) and LY 03012 (about chronic pain). These products are well registered in strategic markets such as China, the United States, Europe and Japan, where they will be listed in the future and further expanded to global markets. (
Sina Pharmaceutical News
)