The board of directors of Luye Pharma Group Ltd. announced that the United States Food and Drug Administration has granted its approval for initiating clinical trials for the Group's new central nervous system (CNS) drug LY03009. LY03009 is indicated for the treatment of Parkinson's disease and restless legs syndrome. It has been developed on the Group's long-acting and extended release technology platform.

LY03009 is a microspheres injection for once-monthly dosing, which can maintain a stable drug level in blood plasma during the target dosing intervals. It possesses the benefit of continuous dopaminergic stimulation, which can delay and treat motor complications and delay introduction of levodopa in the treatment of Parkinson's disease. The maintenance of an effective drug level overnight is expected to improve nocturnal symptoms control and the drug's wake-promotion function.

The one-month target dosing interval can reduce administration frequency, simplify treatment regimen, and thus contribute to the improvement of treatment compliance and clinical outcomes. In addition to the U.S., the drug is also undergoing Phase I clinical trials in Australia and has been approved to initiate clinical trials in China. Currently, it is estimated that about 10 million people around the world are living with Parkinson's disease.

Based on the huge patient population and their needs for treatment, the global market for Parkinson's disease medication is estimated to have reached USD 4.564 billion in 2020, and is projected to reach USD 5.934 billion by 2026, with a compound annual growth rate of 4.68%. According to the Journal of the National Institutes of Health, the prevalence estimates of restless legs syndrome in Europe and North America are 1.9 to 4.6% of the general adult populations. With an ageing population worldwide, the Board believes that LY03009 has promising market prospects and will enrich the Group's future product portfolio.

The Group has launched several products in the CNS therapeutic area, including Risperidone Microspheres for Injection (II), Seroquel and Seroquel XR, Rivastigmine patches and Rivastigmine multi-day transdermal patch, Fentanyl patches and Buprenorphine patches, selling to over 80 countries and regions around the world, including the large pharmaceutical markets in China, the U.S., Europe and Japan, as well as the fast growing emerging markets. In addition, the Group has been developing a number of new drugs concurrently, covering a variety of diseases such as depression and Parkinson's disease, forming a rich product portfolio in the CNS therapeutic area.