Luye Pharma's Global Strategy For CNS-Focused Products Gathers Pace: Rotigotine Extended Release Microspheres Submitted to Japan's PMDA for Clinical Trial Approval
SHANGHAI,Dec. 12,2018 -- Luye Pharma announced that its new investigational drug,Rotigotine Extended Release Microspheres for Injection (LY03003) for the treatment of Parkinson's disease has been submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for clinical trial approval. Meanwhile Phase III clinical trials for LY03003 in the U.S. and China are progressing smoothly.
LY03003 is one of Luye Pharma's key products in the central nervous system (CNS) therapeutic area and can produce Continuous Dopamine Stimulation (CDS) on a long-term basis. Luye Pharma has been developing the drug simultaneously in key strategic markets,such as the U.S.,China,Europe and Japan,preparing to launch first in the U.S. and China,then later to other markets worldwide.
Parkinson's disease has become the third largest killer of middle-aged and elderly people after cancer,cardiovascular and cerebrovascular diseases. According to the Journal of Neurology,Parkinson's disease is the most common movement disorder and is the second most common neurodegenerative disease in Japan. As of 2014,there were approximately 163,000 patients with Parkinson's disease in Japan,with the number still rising. Statistics also show that the number of patients diagnosed with Parkinson's disease in Japan,the U.S.,Germany,the United Kingdom,France,Italy and Spain will increase from 1.9 million in 2014 to 2.3 million in 2023,making the disease a serious cause for concern.
LY03003 is an injection to be administered intramuscularly once a week. It was developed independently by Luye Pharma on its long-acting and extended-release R&D platform. The stable release of the drug in the human body can reduce the "on-off" phenomenon commonly seen in drug treatment for patients with Parkinson's disease and can significantly improve the motor complications which are common for patients with late-stage Parkinson's disease. It is expected that the long-term application of the drug can delay the development of motor complications. Besides this once-weekly dosage,the company is further developing the once-monthly injection of Rotigotine Extended Release Microspheres so as to provide better options for the clinical treatment of Parkinson's disease.
"As global aging worsens,we believe LY03003 will have very good market prospects in the future,further enriching and strengthening the company's current central nervous system portfolio. We are increasing our investment in China,the United States,Europe,and Japan to accelerate the launch speed for self-developed products in several of our most important strategic markets. We hope to accelerate the global launch of these drugs so that they can be accessible to more patients all over the world",said a senior manager at the company.
The central nervous systemtherapeutic field is considered one of the four core therapeutic fields for Luye Pharma's long-term development. A number of drugs in this field are being developed in parallel,both in Chinese and overseas markets. Several drugs have entered the late stages of clinical trials and will soon be launched in major markets around the world. One example,Risperidone Extended Release Microspheres for Injection (LY03004) for the treatment of schizophrenia and bipolar disorder is now in the final stage of the New Drug Application process,with submissions planned for China and the United States. Another example is Ansofaxine Hydrochloride Extended Release Tablets (LY03005) for the treatment of depression,which have entered Phase III clinical trials in China and the United States respectively. Meanwhile,Rivastigmine multi-day patch products for the treatment of Alzheimer's disease are also under clinical development.
In addition to the central nervous system therapeutic area,Luye Pharma has a wealth of pipeline products at home and abroad in the fields of oncology,metabolism,and cardiovascular diseases. Driven by a "global R&D" focused strategy,Luye Pharma has established a global R&D network,with R&D centers covering China,the United States and Europe. Currently,more than 30 drugs are being developed in China,with more than 10 drugs being developed in overseas markets. Luye Pharma has reached a high level international standard in advanced drug delivery technologies such as microspheres,liposomes and transdermal drug delivery systems,with the company making active efforts to develop innovative compounds and antibodies,cells and gene therapies,as well as smart formulations.
To enable patients to benefit the most from these excellent R&D results,Luye Pharma has established 7 manufacturing sites with more than 30 production lines around the world,also maintaining a GMP quality management and control system of the highest international standards. The company has more than 30 marketed products,with a business presence in more than 80 countries and regions around the world,including China,Japan and other major global pharmaceutical markets,as well as high-growth emerging markets. The high standard of the global quality management system coupled with resourceful global market operations capability helps Luye Pharma better provide patients worldwide with high quality,innovative drugs.
