Shanghai, December 28, 2022 - Luye Pharma Group today announced that the Marketing Authorization Application (MAA) for its Paliperidone Palmitate Injection (LY03010) has been accepted by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA). LY03010 is a second-generation long-acting injection developed by Luye Pharma for the acute and maintenance treatment of schizophrenia.

 

Today, there is no long-acting paliperidone palmitate injection developed by a Chinese company approved for marketing in China. After approved, LY03010 will be able to further satisfy the treatment needs of schizophrenia patients and expand Luye Pharma's central nervous system (CNS) portfolio, to reinforce the company’s competitiveness in this therapeutic area. In addition to China, the company also plans to submit the New Drug Application (NDA) for LY03010 to the U.S. Food and Drug Administration (FDA) through the 505(b)(2) pathway following a U.S. pivotal trial for LY03010, which recently met its endpoints.

 

A long-acting injection targeting the difficulties in schizophrenia treatment

 

Schizophrenia is a severe mental disorder affecting more than 24 million people worldwide1. In China, about 10 million people are estimated to be suffering from this disease. The treatment of schizophrenia as a chronic disease that tends to recur and becomes protracted faces the challenges of a high relapse rate and recurring symptoms due to poor patient compliance. Data shows that 60% of patients with the first onset of schizophrenia reported poor compliance with medications and over 80% of them would have a relapse within 5 years. Multiple relapses lead to a prolonged disease duration, increase the difficulty of treatment, and significantly increase the cost of treatment2.

 

Paliperidone is a second-generation antipsychotic recommended as a first-line treatment for schizophrenia. It can relieve positive psychotic symptoms and improve cognitive and affective symptoms in schizophrenia patients. Paliperidone is available in both oral and long-acting injection formulation. Compared with oral formulations, long-acting injections require less frequent administration and lead to stable and effective drug concentrations in the blood for an extended period of time. Such properties can help increase medication compliance, so as to lower patients’ risk of relapse significantly and improve long-term outcomes for patients.  

 

LY03010, with a monthly dosing regimen, is developed on Luye Pharma’s platform for long-acting and targeted drug delivery systems. The MAA for LY03010 is based on a bioequivalence study conducted in schizophrenia patients in China that reached its predefined endpoints with regard to the similarity between LY03010 and the reference listed drug. 

 

Creating unique clinical value with a focus on the CNS therapeutic area

 

Driven by current urgent clinical needs, the sales of antipsychotics in China reached RMB 6.16 billion in 2021 according to statistics from IQVIA’s database for in-hospital drug sales in China. The share of long-acting injections in the global market is also on the rise year-by-year.

 

At present, three second-generation long-acting antipsychotic injections are available in China: Risperidone Microspheres for Injection (II) (Rykindo®), Paliperidone Palmitate Injection, and Paliperidone Palmitate Injection (3M). Among them, Rykindo® of Luye Pharma is China’s first innovative microsphere formulation with IP protection that is seeking registration globally. Rykindo® is also China’s first second-generation long-acting antipsychotic injection developed by a domestic company. Its launch ended the long-term monopoly of this market segment by foreign companies.

 

Yang Rongbing, President of Luye Pharma Group, said: “Schizophrenia is a major mental disorder targeted for prevention and treatment in China. Long-acting antipsychotic injections can be used for the long-term treatment of schizophrenia patients in China, as they can improve patients’ treatment compliance and stabilize their symptoms. LY03010 and Rykindo® will constitute a differentiated portfolio for us and provide new treatment options for patients in need. There are many unmet needs in treating CNS diseases like schizophrenia. Having been in this therapeutic area for many years, we’re committed to serving patients in China and around the world by offering high-quality innovative products.”

 

CNS is a therapeutic area of strategic importance to Luye Pharma. The company has launched several products targeting this area. Apart from Rykindo® mentioned above, there are also Toludesvenlafaxine Hydrochloride Extended-release Tablets (Ruoxinlin®), Quetiapine Fumarate Tablets (Seroquel®), Quetiapine Fumarate Extended-release Tablets, Rivastigmine Once-a-day Transdermal Patch, Rivastigmine Twice-weekly Transdermal Patch, and others, The company operates in over 80 countries and regions around the world, including major pharmaceutical markets like China, the U.S., Europe, and Japan, as well as some high-potential emerging markets. Besides, new investigational drugs such as Rotigotine Extended-release Microspheres for Injection (LY03003) and a VMAT2 inhibitor (LY03015) are under development both in China and abroad. LY03010 is expected to expand the company’s CNS portfolio, produce a synergy with existing resources, reinforce the company’s competitive edge, and accelerate its expansion in this therapeutic area.

 

----------------------------------------------------------

 

 

References: