Luye Pharma : First Step towards Integrating European TDS Business

[24 Feb., 2017, Hong Kong]Luye Pharma Group Ltd. ('Luye Pharma', together with its subsidiaries, 'the Group', stock code: 2186.HK), a leading innovative pharmaceutical company with strong R&D capability and global vision in Chinese market, today announces that it has obtained the approval from the China Food and Drug Administration (the 'CFDA') to commence the development of Buprenorphine
Transdermal Patches in China. This is the first introduced transdermal patches development project since its completion of the acquisition of the Europe-leading TDS business, implying the globalized strategic efforts and efficiency with the core concept of 'Leveraging global resources to embrace China's growth'.

Buprenorphine Transdermal Patches is a pain relief medication developed by Luye Pharma AG ('Luye Germany'), a subsidiary of the Group. The product has been marketed in a number of countries including the United Kingdom, Germany and Spain. It is for the treatment ranging from moderate to severe cancer pain and severe pain immune to non-opioid analgesics. The transdermal patch tablets could release drugs continuously and stably which makes it more convenient and safer than injection and oral formulation. Anesthesia analgesic drug market has a relatively high policy and sales barrier. Currently, there is only one imported Buprenorphine Transdermal Patches which has been approved for sale in China. The Group also plans to seek to register the product in the United States, Japan and South Korea.

As the analgesic treatment in China gets more and more clinical attention, the market is full of development potential. According to IMS, the sales revenue of anesthesia analgesic drug is about RMB 5.8 billion with a cagr of 27.9% from 2012~2016 and reaches 30% in 2016, demonstrating a prosperous market outlook.

It takes only less than 3 months from the TDS busniess acquisition to the approval of introduced products, which presents the integration capabilities of Luye Pharma. Leveraging on the expertise in transdermal patches of Luye Germany's R&D platform, the Group will introduce more transdermal patches in central nervous system therapeutic area, to expand its product pipeline in Chinese market to provide more clinical choices.