LUYE PHARMA(02186): New drug LY03020 approved for clinical trials in the United States

LUYE PHARMA (02186) announced that the group's independently developed new generation antipsychotic drug LY03020 has obtained approval from the US Food and Drug Administration to conduct clinical trials for the treatment of schizophrenia. LY03020 is based on the group's new molecular entity/new therapeutic entity technology platform, and is the world's first dual-target agonist for trace amine-related receptor 1 and serotonin 2C receptor. LY03020 has also entered clinical stages in China. Schizophrenia is a severe mental illness that affects approximately 24 million people globally and 3.7 million people in the United States. About 30% of treatment-resistant schizophrenia patients do not respond well to traditional first and second generation antipsychotic drugs. With the wide clinical demand that remains unmet, there is high hope for the new generation antipsychotic drugs to be different and improve the positive, negative, and cognitive symptoms of schizophrenia. LY03020 targets TAAR1 and 5-HT2CR dual receptors. TAAR1 is mainly expressed in the presynaptic membrane, and its activation can lead to a decrease in the release of neurotransmitters such as dopamine and serotonin into the synaptic cleft. 5-HT2CR is expressed in both presynaptic and postsynaptic membranes. Activation of the presynaptic receptor can further reduce neurotransmitter release, increasing the efficacy in controlling negative symptoms. Activation of the postsynaptic receptor can help control side effects such as weight gain and metabolic syndrome. Preclinical studies have shown that LY03020 can significantly improve positive, negative, and cognitive symptoms of schizophrenia without significant risks of extrapyramidal symptoms, weight gain, or metabolic syndrome. There is a great demand for the treatment of central nervous system diseases including schizophrenia, but the development of new drugs progresses relatively slowly. The group has successfully launched a number of internationally competitive and differentiated product combinations in the field of CNS therapy. The group's product portfolio in the CNS therapy field includes Erzofri (paliperidone palmitate suspension for injection) and Rykindo (risperidone microspheres for injection) approved for market in the US, as well as Ruoxinlin (tolterodine tartrate extended-release tablets) and Jinyouping (ritonavir microspheres injection) marketed in China. In addition, the group has multiple first-class innovative drugs in clinical stages, including LY03021 targeting NET/DAT/GABAAR triple receptors and LY03015 targeting VMAT2/Sigma1 dual receptors.