Shanghai, April 15th, 2026 — Luye Pharma Group today announced that the first subject has been enrolled in a Phase Ⅱ clinical trial in China to evaluate its LY03017 for the treatment of Alzheimer’s Disease-related Psychosis (ADP). Filed through China’s Class 1 pathway for innovative drugs, LY03017 is a next-generation serotonin 2A receptor (5-HT2AR) inverse agonist and a serotonin 2C receptor (5-HT2CR) antagonist. The drug is intended for treating ADP, Parkinson’s Disease Psychosis (PDP), and Negative Symptoms of Schizophrenia (NSS).
Luye Pharma maintains a long-standing commitment to the central nervous system (CNS) therapeutic area, with LY03017 representing another new molecular entity under development in both China and the U.S. The Phase Ⅱ clinical trial in China is a randomized, double-blind, parallel-group, and placebo-controlled trial to evaluate the preliminary efficacy and safety of LY03017 for the treatment of hallucinations and delusions associated with psychosis in Alzheimer’s disease (AD). LY03017 has also been cleared to initiate clinical trials in the U.S.
AD is one of the most prevalent neurodegenerative diseases and the leading cause of dementia. According to the World Health Organization, more than 57 million people worldwide are living with dementia, and approximately 60% to 70% of them are AD patients.1 As the disease progresses, approximately 25% to 50% of the patients will develop psychotic symptoms, primarily delusions and hallucinations.2 Such symptoms are associated with greater cognitive and functional impairments, dementia severity, and caregiver burden.3 Currently, no therapies have been approved worldwide for the treatment of ADP, representing a significant unmet medical need.
LY03017 is a next-generation dual-target investigational drug which acts as a 5-HT2AR inverse agonist and a 5-HT2CR antagonist to modulate dopamine-related neural pathways. It is designed to reduce abnormal neural activities associated with hallucinations and delusions, having the potential to improve key symptoms of ADP and PDP. In addition, the drug also has the potential to improve cognitive impairments associated with insufficient dopaminergic signaling in the prefrontal cortex and alleviate negative symptoms such as apathy.
Results from a Phase I clinical trial conducted in China showed that LY03017 was generally safe and well tolerated in both healthy adults and seniors. All observed adverse events were mild to moderate, and no serious treatment-emergent adverse events (TEAEs) were observed. Based on its human pharmacokinetics (PK), LY03017 was rapidly absorbed following oral administration, exhibited a linear PK profile, and reached steady state after approximately three days of repeated dosing.
The CNS therapeutic area is a strategic focus for Luye Pharma. The company has built a differentiated product portfolio targeting multiple conditions such as major depressive disorder, schizophrenia, bipolar disorder, and AD. This portfolio includes two extended-release injectable suspensions -- Erzofri® (paliperidone palmitate) and Rykindo® (risperidone), both approved for marketing in the U.S.; the Rivastigmine Twice Weekly Transdermal Patch, which has been approved for marketing in Japan, China, and several European countries; and Ruoxinlin® (Toludesvenlafaxine Hydrochloride Sustained-Release Tablets), which has been approved for marketing in China. Luye Pharma is also conducting clinical trials for several other investigational drugs, including LY03015, which targets VMAT2/Sigma-1R, LY03020, which targets TAAR1/5-HT2CR, and LY03021, which targets GABAAR/NET/DAT.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to developing, manufacturing, and selling innovative medications. With R&D centers in China, the U.S., and Europe, the company is an international leader in novel drug delivery systems such as microspheres, liposomes, and transdermal patches. It also has multiple innovative products in two categories: new chemical entities and antibodies. From 2021 to 2025, the company has had a total of 15 new drugs approved for marketing in one or multiple countries such as the U.S., China, Japan, and several European countries.
Luye Pharma has 8 manufacturing facilities worldwide, which follow internationally accepted, GMP-compliant quality management and control systems. To date, the company has launched approximately 50 products in the oncology, central nervous system, cardiovascular, and other therapeutic areas. It conducts business in over 80 countries and regions, including major pharmaceutical markets such as China, the U.S., Europe, and Japan, and also including fast-growing emerging markets.
References：
Shanghai, April 15th, 2026 — Luye Pharma Group today announced that the first subject has been enrolled in a Phase Ⅱ clinical trial in China to evaluate its LY03017 for the treatment of Alzheimer’s Disease-related Psychosis (ADP). Filed through China’s Class 1 pathway for innovative drugs, LY03017 is a next-generation serotonin 2A receptor (5-HT2AR) inverse agonist and a serotonin 2C receptor (5-HT2CR) antagonist. The drug is intended for treating ADP, Parkinson’s Disease Psychosis (PDP), and Negative Symptoms of Schizophrenia (NSS).
Luye Pharma maintains a long-standing commitment to the central nervous system (CNS) therapeutic area, with LY03017 representing another new molecular entity under development in both China and the U.S. The Phase Ⅱ clinical trial in China is a randomized, double-blind, parallel-group, and placebo-controlled trial to evaluate the preliminary efficacy and safety of LY03017 for the treatment of hallucinations and delusions associated with psychosis in Alzheimer’s disease (AD). LY03017 has also been cleared to initiate clinical trials in the U.S.
AD is one of the most prevalent neurodegenerative diseases and the leading cause of dementia. According to the World Health Organization, more than 57 million people worldwide are living with dementia, and approximately 60% to 70% of them are AD patients.1 As the disease progresses, approximately 25% to 50% of the patients will develop psychotic symptoms, primarily delusions and hallucinations.2 Such symptoms are associated with greater cognitive and functional impairments, dementia severity, and caregiver burden.3 Currently, no therapies have been approved worldwide for the treatment of ADP, representing a significant unmet medical need.
LY03017 is a next-generation dual-target investigational drug which acts as a 5-HT2AR inverse agonist and a 5-HT2CR antagonist to modulate dopamine-related neural pathways. It is designed to reduce abnormal neural activities associated with hallucinations and delusions, having the potential to improve key symptoms of ADP and PDP. In addition, the drug also has the potential to improve cognitive impairments associated with insufficient dopaminergic signaling in the prefrontal cortex and alleviate negative symptoms such as apathy.
Results from a Phase I clinical trial conducted in China showed that LY03017 was generally safe and well tolerated in both healthy adults and seniors. All observed adverse events were mild to moderate, and no serious treatment-emergent adverse events (TEAEs) were observed. Based on its human pharmacokinetics (PK), LY03017 was rapidly absorbed following oral administration, exhibited a linear PK profile, and reached steady state after approximately three days of repeated dosing.
The CNS therapeutic area is a strategic focus for Luye Pharma. The company has built a differentiated product portfolio targeting multiple conditions such as major depressive disorder, schizophrenia, bipolar disorder, and AD. This portfolio includes two extended-release injectable suspensions -- Erzofri® (paliperidone palmitate) and Rykindo® (risperidone), both approved for marketing in the U.S.; the Rivastigmine Twice Weekly Transdermal Patch, which has been approved for marketing in Japan, China, and several European countries; and Ruoxinlin® (Toludesvenlafaxine Hydrochloride Sustained-Release Tablets), which has been approved for marketing in China. Luye Pharma is also conducting clinical trials for several other investigational drugs, including LY03015, which targets VMAT2/Sigma-1R, LY03020, which targets TAAR1/5-HT2CR, and LY03021, which targets GABAAR/NET/DAT.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to developing, manufacturing, and selling innovative medications. With R&D centers in China, the U.S., and Europe, the company is an international leader in novel drug delivery systems such as microspheres, liposomes, and transdermal patches. It also has multiple innovative products in two categories: new chemical entities and antibodies. From 2021 to 2025, the company has had a total of 15 new drugs approved for marketing in one or multiple countries such as the U.S., China, Japan, and several European countries.
Luye Pharma has 8 manufacturing facilities worldwide, which follow internationally accepted, GMP-compliant quality management and control systems. To date, the company has launched approximately 50 products in the oncology, central nervous system, cardiovascular, and other therapeutic areas. It conducts business in over 80 countries and regions, including major pharmaceutical markets such as China, the U.S., Europe, and Japan, and also including fast-growing emerging markets.
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