Shanghai, April 8th, 2026 – Luye Pharma Group today announced that the first subject has been enrolled in a Phase Ⅱ clinical trial in China evaluating its LY03020 for the treatment of schizophrenia. Filed through China’s Class 1 pathway for innovative drugs, LY03020 is the world’s first agonist for both the trace amine-associated receptor 1 (TAAR1) and the serotonin 2C receptor (5-HT2CR). In addition to schizophrenia, it is also intended to treat Alzheimer's disease psychosis and bipolar disorder.
The Phase Ⅱ clinical trial in China is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dose study designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of LY03020 in patients with acute schizophrenia, and to determine its effective dosage range. LY03020 has also been cleared to initiate clinical trials in the U.S., making it another innovative central nervous system (CNS) therapeutic of Luye Pharma developed simultaneously both in China and abroad.
Schizophrenia is a chronic disease with high rates of relapse and disability. It affects 23 million people worldwide, of which 8 million are in China.1,2 The first- and second-generation antipsychotics are ineffective in about 30% of patients3. These agents primarily improve positive symptoms but show limited efficacy against negative and cognitive symptoms. Moreover, they are prone to induce adverse effects including extrapyramidal symptoms (EPS), weight gain, elevated prolactin levels, and abnormal glucose and lipid metabolism.
Developed on the company’s New Chemical Entity/New Therapeutic Entity (NCE/NTE) platform, LY03020 is a next-generation antipsychotic targeting both TAAR1 and 5-HT2CR, rather than the serotonin 1A receptor (5-HT1AR), which is known to desensitize after four to six weeks of continuous activation, leading to a gradual loss of therapeutic efficacy. TAAR1 is primarily expressed on the presynaptic membrane, and its activation reduces the release of monoamine neurotransmitters such as dopamine (DA) and serotonin (5-HT) into the synaptic cleft, which helps improve the core symptoms of schizophrenia. The activation of 5-HT2CR further lowers the release of neurotransmitters like 5-HT, contributing to improved control of negative symptoms, while modulating neuronal firing to enhance the management of positive symptoms. In addition, it also helps reduce metabolic syndrome such as weight gain and abnormal glucose/lipid levels.
In early-stage studies, LY03020 demonstrated a promising efficacy and safety profile. Specifically, preclinical studies showed that the drug could significantly improve the positive and negative symptoms of schizophrenia and the cognitive impairments associated with it. Compared with representative investigational and commercially available drugs, LY03020 has shown pronounced efficacy without noticeable risks for EPS, metabolic syndrome such as weight gain and abnormal glucose/lipid levels, or gastrointestinal adverse reactions. In addition, LY03020 was well-tolerated and demonstrated a favorable safety profile in the Phase Ⅰ clinical trial conducted in China. All treatment-emergent adverse events were mild to moderate, with zero occurrences of EPS or serious adverse events.
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 (MDD), schizophrenia, bipolar disorder, and Alzheimer’s disease. This portfolio includes Erzofri® (paliperidone palmitate) extended-release injectable suspension and Rykindo® (risperidone) for extended-release injectable suspension, both approved for marketing in the U.S.; Rivastigmine Twice Weekly Transdermal Patch, which has been approved for marketing in Japan, China, and several European countries; as well as Ruoxinlin® (Toludesvenlafaxine Hydrochloride Sustained-Release Tablets), which has been approved for marketing in China. In addition to LY03020, Luye Pharma is also conducting clinical trials for several other investigational drugs, including LY03015, which targets VMAT2/Sigma-1R, LY03017, which targets 5-HT2AR/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 over 30 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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Shanghai, April 8th, 2026 – Luye Pharma Group today announced that the first subject has been enrolled in a Phase Ⅱ clinical trial in China evaluating its LY03020 for the treatment of schizophrenia. Filed through China’s Class 1 pathway for innovative drugs, LY03020 is the world’s first agonist for both the trace amine-associated receptor 1 (TAAR1) and the serotonin 2C receptor (5-HT2CR). In addition to schizophrenia, it is also intended to treat Alzheimer's disease psychosis and bipolar disorder.
The Phase Ⅱ clinical trial in China is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dose study designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of LY03020 in patients with acute schizophrenia, and to determine its effective dosage range. LY03020 has also been cleared to initiate clinical trials in the U.S., making it another innovative central nervous system (CNS) therapeutic of Luye Pharma developed simultaneously both in China and abroad.
Schizophrenia is a chronic disease with high rates of relapse and disability. It affects 23 million people worldwide, of which 8 million are in China.1,2 The first- and second-generation antipsychotics are ineffective in about 30% of patients3. These agents primarily improve positive symptoms but show limited efficacy against negative and cognitive symptoms. Moreover, they are prone to induce adverse effects including extrapyramidal symptoms (EPS), weight gain, elevated prolactin levels, and abnormal glucose and lipid metabolism.
Developed on the company’s New Chemical Entity/New Therapeutic Entity (NCE/NTE) platform, LY03020 is a next-generation antipsychotic targeting both TAAR1 and 5-HT2CR, rather than the serotonin 1A receptor (5-HT1AR), which is known to desensitize after four to six weeks of continuous activation, leading to a gradual loss of therapeutic efficacy. TAAR1 is primarily expressed on the presynaptic membrane, and its activation reduces the release of monoamine neurotransmitters such as dopamine (DA) and serotonin (5-HT) into the synaptic cleft, which helps improve the core symptoms of schizophrenia. The activation of 5-HT2CR further lowers the release of neurotransmitters like 5-HT, contributing to improved control of negative symptoms, while modulating neuronal firing to enhance the management of positive symptoms. In addition, it also helps reduce metabolic syndrome such as weight gain and abnormal glucose/lipid levels.
In early-stage studies, LY03020 demonstrated a promising efficacy and safety profile. Specifically, preclinical studies showed that the drug could significantly improve the positive and negative symptoms of schizophrenia and the cognitive impairments associated with it. Compared with representative investigational and commercially available drugs, LY03020 has shown pronounced efficacy without noticeable risks for EPS, metabolic syndrome such as weight gain and abnormal glucose/lipid levels, or gastrointestinal adverse reactions. In addition, LY03020 was well-tolerated and demonstrated a favorable safety profile in the Phase Ⅰ clinical trial conducted in China. All treatment-emergent adverse events were mild to moderate, with zero occurrences of EPS or serious adverse events.
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 (MDD), schizophrenia, bipolar disorder, and Alzheimer’s disease. This portfolio includes Erzofri® (paliperidone palmitate) extended-release injectable suspension and Rykindo® (risperidone) for extended-release injectable suspension, both approved for marketing in the U.S.; Rivastigmine Twice Weekly Transdermal Patch, which has been approved for marketing in Japan, China, and several European countries; as well as Ruoxinlin® (Toludesvenlafaxine Hydrochloride Sustained-Release Tablets), which has been approved for marketing in China. In addition to LY03020, Luye Pharma is also conducting clinical trials for several other investigational drugs, including LY03015, which targets VMAT2/Sigma-1R, LY03017, which targets 5-HT2AR/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 over 30 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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