Luye Pharma (02186.HK) issued a voluntary announcement stating that its independently developed innovative drug...The first subject has been enrolled in the Phase II clinical trial in China of LY03017 for the treatment of psychotic disorders in Alzheimer's disease. LY03017 is a new-generation 5-HT2AR inverse agonist and 5-HT2CR antagonist, with target indications including psychotic disorders in Alzheimer's disease, psychotic disorders in Parkinson's disease, and negative symptoms of schizophrenia. This Phase II clinical trial is a randomized, double-blind, parallel, placebo-controlled study designed to evaluate the preliminary efficacy and safety of LY03017 in treating hallucinations and delusions associated with Alzheimer's disease; the drug has previously been approved for clinical trials in the United States. Background: Of the approximately 57 million dementia patients worldwide, 60% to 70% have Alzheimer's disease, of whom 25% to 50% experience psychotic symptoms. Currently, there are no approved drugs worldwide for this indication. The Phase I clinical trial of LY03017 in China demonstrated good safety and tolerability in healthy adults and elderly subjects, with all adverse events being mild to moderate, and no serious treatment-related adverse events occurring. The pharmacokinetics were linear, and steady state was reached after approximately 3 days of continuous administration. The Group will accelerate the Phase II clinical trial to verify its therapeutic advantages and strive to meet unmet clinical needs as soon as possible. Central nervous system therapy is a core strategic area for the Group, which has already formed a differentiated product portfolio covering depression, schizophrenia, Alzheimer's disease, etc., and has several dual/triple-target new drugs in clinical trials.

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