LUYE PHARMA (02186) surged more than 3%, reaching HK$3.2 by the time of writing, with a trading volume of HK$28.32 million. On November 24, the company announced that its self-developed novel drug LY03017, a next-generation 5-HT2AR inverse agonist and 5-HT2CR antagonist, has received approval from the U.S. Food and Drug Administration (FDA) to commence clinical trials. LY03017 is intended for treating Alzheimer’s disease psychosis (ADP), Parkinson’s disease psychosis (PDP), and negative symptoms of schizophrenia (NSS). The FDA has waived the single ascending dose (SAD) phase in the Phase I trial, allowing the drug to proceed directly to multiple ascending dose (MAD) and subsequent clinical trials. Developed under the company’s new molecular entity/therapeutic entity platform, LY03017 represents another innovative drug in the central nervous system (CNS) therapeutic area being developed simultaneously in China and the U.S. Currently, LY03017 is also in Phase I clinical trials in China. Globally, only one drug has been approved by the FDA for PDP treatment, and it has not yet been approved in China. For ADP, no drugs have been approved domestically or internationally, while for NSS, only a few drugs show limited efficacy. These three indications represent significant unmet medical needs.