Luye Pharma’s LY03020 Receives NMPA Approval for Schizophrenia and Alzheimer’s Psychosis Treatment

Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate LY03020, intended for the treatment of schizophrenia and Alzheimer’s disease psychosis (ADP).

LY03020 is developed using Luye’s innovative New Molecular Entity/New Therapeutic Entity (NCE/NTE) technology platform and is touted as the world’s first dual-target agonist of trace-amine associated receptor 1 (TAAR1) and the 5-hydroxytryptamine type 2C receptor (5-HT2CR).

In China, schizophrenia affects approximately 8 million individuals, with around 30% of patients with refractory schizophrenia experiencing inadequate responses to traditional first- and second-generation antipsychotic medications. Additionally, nearly 9.83 million people in China are diagnosed with Alzheimer’s disease, a number that continues to rise. Among these, about 30% suffer from ADP, which is characterized by psychotic symptoms such as aggression, agitation, hallucinations, and delusions. Preclinical studies indicate that LY03020 can significantly alleviate both positive and negative symptoms of schizophrenia and cognitive impairments associated with ADP, all while avoiding significant extrapyramidal reactions (EPS) and metabolic syndrome risks, including weight gain and abnormal glucose and lipid metabolism.- Flcube.com

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