Luye Pharma : Obtains Clinical Trials Approval for Rivastigmine Multi-day Patch in Germany

[1 March., 2017, Hong Kong], Luye Pharma Group Ltd. (the 'Company', together with its subsidiaries, the 'Group', stock code: 2186.HK), a leading innovative pharmaceutical company with strong R&D capability and global vision in China's market, today announces that the Group has obtained the approval from the Federal Institute for Drugs and Medical Devices in Germany (the German health authority) to commence clinical trials for Rivastigmine Multi-day Transdermal Patch (''Rivastigmine MD''), an innovative delivery system drug being developed by the Group for the treatment of Alzheimer's disease. This is the new R&D progress the Group has made since its acquisition of TDS business in Europe.

Rivastigmine MD is a key product targeting at central nervous system disease developed by the Group's patch R&D platform which was established by its subsidiary Luye Pharma AG. Rivastigmine MD is designed to deliver rivastigmine constantly over a period of up to 4 days and has a lower application frequency and is more convenient than the once-daily rivastigmine patches generally available in the market. This product and its formulation methods are protected globally under a number of patents. Having marketed rivastigmine once-daily patches in the United States and Europe, Luye Germany has a proven track record of product R&D and successful product launches.The Group also plans to register this product in other European countries, the United States, Japan and China.

According to the data from Quintiles IMS Holdings, the global market size in terms of annual sales of rivastigmine formulation has reached USD1.2 billion in 2015. The Company believes that Rivastigmine MD has good market potential and will enrich the CNS product portfolio and strengthen its competitiveness in central nervous system therapeutic area.

In addition to Rivastigmine MD, the Group is also developing other new drugs based on its transdermal patch and implant R&D platform including the Buprenorphine Transdermal Patches which has obtained approval from the China Food and Drug Administration (the ''CFDA'') to commence the development in China . The Group believes by leveraging its abundant experience in R&D of new formulation, global R&D system and capabilities and experience in business integration, Luye Pharma is expected to deliver multiple products into the global markets over the next few years. Luye Pharma will as always set innovation and development as a long-term driving force for enterprise development so as to provide high quality innovation products and solutions for patients home and abroad.