News>Press Releases
Luye Pharma’s Innovative Long-acting Microspheres Injection LY03009 for Treating Parkinson’s Disease Soon to Begin Clinical Trials in China
October 27,2021
 Luye Pharma Group today announced that its investigational drug LY03009 has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for clinical trials in China. LY03009 is for treating Parkinson’s disease. It is developed on Luye Pharma’s world-leading long-acting and extended release technology platform. In addition to China, the drug is also undergoing Phase I clinical trials in Australia, with a plan for clinical trials in the U.S. as well.

Parkinson's disease is a neurodegenerative disease common for middle-aged and older people, characterized by clinical manifestations of motor symptoms such as tremor, myotonia, bradykinesia, and postural instability as well as non-motor symptoms such as sleep disorder, olfactory dysfunction, autonomic dysfunction, cognitive impairment, and mental disorder. Currently, pharmacological and surgical treatments can only improve symptoms, but can’t cure the disease or prevent its progression, making long-term management necessary1. 

Levodopa is the standard therapy for Parkinson's disease. However, with disease progression and the long-time use of levodopa, most patients will experience motor complications such as “on-off” phenomenon, end-of-dose deterioration, and dystonia caused by intermittent dopaminergic stimulation. As common symptoms in the advanced stages of Parkinson's disease, motor complications seriously affect patients’ quality of life and pose challenges to treatment.

LY03009 is a once-a-month, long-acting microspheres injection and has the benefit of providing continuous dopaminergic stimulation. It can postpone the introduction of levodopa in the treatment process, to provide long-term clinical benefits for patients and effectively slow down disease progression. Specifically, the potential benefits of LY03009 include the following:

· Significantly improving motor symptoms for patients with Parkinson's disease, such as effectively shortening the “off” period, postponing the onset of motor complications, and improving morning dyskinesia and nocturnal symptoms;
· Improving non-motor symptoms of Parkinson's disease such as sleep disorder, dysphagia, and gastrointestinal disorder;
· More convenient once-a-month administration, which reduces the frequency of medication, simplifies the regimen, and increases patient compliance.

With the growing number of Parkinson's disease patients in China, the burden associated with that is also increasing. Statistics shows that, China’s number of Parkinson’s disease patients will increase from 1.99 million in 2005 to nearly 5 million by 2030, almost half of the world’s total number of Parkinson’s disease patients.

Yang Rongbing, President of Luye Pharma Group, said: “With the progression of Parkinson's disease as a common neurodegenerative disease,  the symptoms will become worse, and the patients will need long-term care. This presents a huge challenge to their quality of life and their family’s ability to take care of them. We want to provide a new treatment option for those patients, to help them reduce disease burdens and slow down disease progression, and to improve the quality of life for themselves and their family members.”

Leveraging its world-leading R&D platform for long-acting and extended release technology, Luye Pharma has been developing innovative microspheres with a dosing cycle from one week to several months to meet the needs of patients in major therapeutic areas such as the central nervous system (CNS) and oncology. These products are going through registration processes or clinical trials in major pharmaceutical markets around the world. For example, the Risperidone Microspheres for Injection (II) (Rykindo®) has been approved for launch in China and are in the New Drug Application (NDA) stage in the U.S.; and the Goserelin Acetate Extended-release Microspheres for Injection (LY01005) has completed the Phase III clinical trials for the treatment of prostate cancer in China. The new drugs to be launched later will form a strong portfolio with the company's products that have already been launched. And working in synergy with the company’s existing resources and strengths, they will accelerate the company's strategic presence in key therapeutic areas around the globe.
News>Press Releases
Luye Pharma’s Innovative Long-acting Microspheres Injection LY03009 for Treating Parkinson’s Disease Soon to Begin Clinical Trials in China
October 27,2021
 Luye Pharma Group today announced that its investigational drug LY03009 has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for clinical trials in China. LY03009 is for treating Parkinson’s disease. It is developed on Luye Pharma’s world-leading long-acting and extended release technology platform. In addition to China, the drug is also undergoing Phase I clinical trials in Australia, with a plan for clinical trials in the U.S. as well.

Parkinson's disease is a neurodegenerative disease common for middle-aged and older people, characterized by clinical manifestations of motor symptoms such as tremor, myotonia, bradykinesia, and postural instability as well as non-motor symptoms such as sleep disorder, olfactory dysfunction, autonomic dysfunction, cognitive impairment, and mental disorder. Currently, pharmacological and surgical treatments can only improve symptoms, but can’t cure the disease or prevent its progression, making long-term management necessary1. 

Levodopa is the standard therapy for Parkinson's disease. However, with disease progression and the long-time use of levodopa, most patients will experience motor complications such as “on-off” phenomenon, end-of-dose deterioration, and dystonia caused by intermittent dopaminergic stimulation. As common symptoms in the advanced stages of Parkinson's disease, motor complications seriously affect patients’ quality of life and pose challenges to treatment.

LY03009 is a once-a-month, long-acting microspheres injection and has the benefit of providing continuous dopaminergic stimulation. It can postpone the introduction of levodopa in the treatment process, to provide long-term clinical benefits for patients and effectively slow down disease progression. Specifically, the potential benefits of LY03009 include the following:

· Significantly improving motor symptoms for patients with Parkinson's disease, such as effectively shortening the “off” period, postponing the onset of motor complications, and improving morning dyskinesia and nocturnal symptoms;
· Improving non-motor symptoms of Parkinson's disease such as sleep disorder, dysphagia, and gastrointestinal disorder;
· More convenient once-a-month administration, which reduces the frequency of medication, simplifies the regimen, and increases patient compliance.

With the growing number of Parkinson's disease patients in China, the burden associated with that is also increasing. Statistics shows that, China’s number of Parkinson’s disease patients will increase from 1.99 million in 2005 to nearly 5 million by 2030, almost half of the world’s total number of Parkinson’s disease patients.

Yang Rongbing, President of Luye Pharma Group, said: “With the progression of Parkinson's disease as a common neurodegenerative disease,  the symptoms will become worse, and the patients will need long-term care. This presents a huge challenge to their quality of life and their family’s ability to take care of them. We want to provide a new treatment option for those patients, to help them reduce disease burdens and slow down disease progression, and to improve the quality of life for themselves and their family members.”

Leveraging its world-leading R&D platform for long-acting and extended release technology, Luye Pharma has been developing innovative microspheres with a dosing cycle from one week to several months to meet the needs of patients in major therapeutic areas such as the central nervous system (CNS) and oncology. These products are going through registration processes or clinical trials in major pharmaceutical markets around the world. For example, the Risperidone Microspheres for Injection (II) (Rykindo®) has been approved for launch in China and are in the New Drug Application (NDA) stage in the U.S.; and the Goserelin Acetate Extended-release Microspheres for Injection (LY01005) has completed the Phase III clinical trials for the treatment of prostate cancer in China. The new drugs to be launched later will form a strong portfolio with the company's products that have already been launched. And working in synergy with the company’s existing resources and strengths, they will accelerate the company's strategic presence in key therapeutic areas around the globe.