Luye Pharma’s Monthly Long-Acting Microspheres Injection LY03009 Starts Phase I Clinical Study in Australia

Luye Pharma Group has announced the beginning of the phase I clinical study of the company’s self-developed microsphere injection LY03009 in Australia. LY03009 is a monthly injection indicated for Parkinson’s disease (PD) and moderate to severe Restless legs syndrome (RLS). It is one of the key Central Nervous System (CNS) product candidates developed on the company’s long-acting and extended-release formulation platform. 

Luye Pharma has defined a long-term strategy for the development of novel drug delivery technologies such as microspheres, in which the company has achieved international advanced level. Microsphere products are complex injectable products that are demanding in terms of technical knowhow and difficult to industrialize. Luye Pharma is one of the few Chinese companies in possession of the high-end technology involved, breaking open a long-term monopoly of overseas drug makers. The company has developed a series of microsphere product candidates, with registration work and clinical studies ongoing in major international markets including China, America, Europe, and Japan.

LY03009 Improves Clinical Outcomes and Compliance with a Dosing Frequency of One Injection per Month

LY03009 is a microspheres injection for monthly dosing, helping to maintain a stable level of thedrug in plasma between the target dosing intervals. It has the benefits of continuous dopaminergic stimulation, which will reduce the risk of motor complications and delay the introduction of levodopa in the treatment of Parkinson’s disease. The ability to maintain an effective level of the drug through the night is expected to improve both nocturnal symptom control and function on awakening. The targeted monthly dosing interval reduces the frequency of administration, simplifies the regimen, and provides convenience, and will ultimately contribute to better treatment compliance and improved clinical outcomes.


Focus on CNS and Other Core Therapeutic Areas to Fulfil More Clinical Needs

PD and RLS are both defined as CNS diseases. According to the Journal of Neurology, Parkinson’s disease is the most common movement disorder and the second most common neurodegenerative disease. Approximately 1-2% of the population over 65 years of age suffer from Parkinson’s disease. This figure increases to 3-5% for the population over 85 years of age. RLS is also a common disease among the middle-aged and elderly which severely reduces the sufferer’s quality of life.


“As the global population ages, the number of PD and RLS patients continues to grow, with a large volume of clinical demand waiting to be met," said a senior management representative from Luye Pharma Group. “The serious distress caused by these diseases has an enormous impact on both patients and their families. We look forward to bringing more high-quality and innovative drugs to the market, helping these patients in need.”


CNS is one of Luye Pharma’s core therapeutic areas. The company has formed a robust product pipeline in this field, covering depression, Parkinson's disease, schizophrenia, bipolar disorder, and Alzheimer's disease, among others, with a number of investigational drugs already in the late stages of clinical trials and the New Drug Application phase in China, the U.S., Europe and other international markets.