Date: 31-Dec-2019

Luye Pharma's Risperidone gets priority review by CDE

Luye Pharma Group has announced that the New Drug Application (NDA) for Risperidone Extended-Release Microspheres for Injection (LY03004), an innovative formulation independently developed by the company, has been granted priority review by the Center for Drug Evaluation (CDE) under the China’s National Medical Products Administration (NMPA), and the drug is likely to be accelerated for launch in China. The NDA review for LY03004 has entered the late stage in the US, and the manufacturing facility of the drug had successfully passed the US Food and Drug Administration (FDA) Pre-Approval Inspection (PAI). LY03004 is an extended-release microsphere product administered once every two weeks by intramuscular injection to treat schizophrenia. The drug was granted priority review by CDE in China for its sufficient clinical advantage. LY03004 is a microsphere product independently developed by Luye Pharma through its State Key Laboratory for Long-acting and Targeting Drug Delivery Systems. It is also the first innovative formulation to enter the NDA stage in the U.S. Microsphere products are complex injectable products with high technical barriers and difficulty in industrialization. Luye Pharma is among a few Chinese companies in possession of this high-end key preparation technology, breaking the long-term monopoly of this technology by overseas drug makers. LY03004 registration is underway globally. Previously, key clinical trials have been completed in both China and the US. Principal Investigators in China are Professor Cui Yimin from Peking University First Hospital and Professor Wang Gang from Anding Hospital of Capital Medical University. In May this year, the NDA filing for LY03004 was accepted by the FDA; in November, the manufacturing facility of the drug passed the PAI of the FDA with no FDA-483, Inspectional Observations. According to the World Health Organization, there are more than 21 million people worldwide suffering from schizophrenia, with one in every two patients with schizophrenia left untreated. According to data from the Center for Mental Health at the Chinese Center for Disease Control and Prevention, there were over 100 million people in China with mental illness, and more than 6.4 million of them suffered from schizophrenia1. As a severe type of mental illness, schizophrenia is difficult to treat in part due to the high recurrence rate as well as the relapse caused by the low treatment compliance of the patients. As a long-acting injectable drug administered bi-weekly, LY03004 can help improve medication compliance issues which are common among patients with schizophrenia in relation to oral antipsychotic drugs, and simplify the treatment regimen. LY03004 also has several advantages over the marketed reference drug. For example, there is no need to administer oral formulation for three weeks after the first injection of LY03004, unlike with the reference drug, and steady plasma drug level can be reached much faster with LY03004 than with the reference product. "The number of patients with mental illness is growing with a lot of unmet therapeutic needs, and we hope that this new drug can be launched soon to bring a new treatment option for them," said a Luye Pharma Group management representative. "We will work full steam ahead to drive the development and launch of several new drugs in central nervous system in the future and enable more patients around the world to benefit from them." Currently, Luye Pharma has several pipeline projects focusing on the CNS therapeutic area in the NDA filing stage or late clinical study stage, which are expected to be launched in major global markets starting from 2020. In addition to LY03004, the NDA filing has also been made for LY03005, for treating major depressive disorder in the US, and there are also other pipeline projects including LY03003 for Parkinson's disease, LY03010 for schizophrenia and schizoaffective disorder, LY30410 for moderate to mild Alzheimer's disease, and LY03012 for chronic pains. The registration work in relation to the above pipeline products has been progressing well in major pharmaceutical markets such as China, the US, Europe and Japan. These products are expected to be launched in these countries and further expanded into the global markets.