Shanghai, August 5, 2026 - Luye Pharma Group today announced the successful completion of a U.S. bridging clinical trial of its in-house developed new molecular entity, LY03015. The results support the commencement of the upcoming efficacy clinical trial of the investigational drug in the U.S. Notably, LY03015 demonstrated a more favorable safety and tolerability profile in Caucasian subjects than in Chinese subjects.
LY03015 is the world's first investigational drug designed to inhibit vesicular monoamine transporter 2 (VMAT2) and activate the sigma-1 receptor (Sigma-1R). It is intended for the treatment of tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD). Luye Pharma has previously completed a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II clinical trial in China, in which a total of 121 patients with moderate to severe TD participated. The results showed that, following six consecutive weeks of administration, all three LY03015 dose groups demonstrated robust efficacy, with rapid and significant improvement in TD symptoms and a clear dose-response relationship. In particular, the Abnormal Involuntary Movement Scale (AIMS) response rate in the 20 mg dose group, defined as the proportion of patients achieving an improvement of ≥50% in AIMS items 1-7, reached 76.5%. This response rate exceeded historical treatment benchmarks and was nearly double the response levels reported in publicly available data from double-blind, controlled, registrational clinical trials of current first-line therapeutic drugs.
The U.S. bridging clinical study was an open-label, single-dose, parallel-group study designed to evaluate the pharmacokinetics, safety and tolerability of LY03015 following a single 20 mg oral dose in healthy Chinese and Caucasian subjects. A total of 12 healthy Chinese subjects and 12 healthy Caucasian subjects participated in the study, and the results showed the following:
- no difference in the pharmacokinetics of LY03015 was observed between Caucasian and Chinese subjects;
- overall safety and tolerability were favorable, with all treatment-emergent adverse events (TEAEs) being mild in severity and no serious adverse events (SAEs) being reported; and
- safety and tolerability were notably more favorable in Caucasian subjects than in Chinese subjects, with TEAE incidence rates of 33.3% and 83.3%, respectively.
The study demonstrated that the pharmacokinetics of LY03015 are comparable between Caucasian and Chinese subjects, while its safety and tolerability are more favorable for Caucasian subjects. Based on the results of the phase II clinical trial in China, Luye Pharma plans to adopt a simplified dosing regimen for patients enrolled in its planned efficacy clinical trial in the U.S. Compared with the dose-titration regimens commonly adopted in current clinical practice, LY03015 is expected to demonstrate a differentiated market value proposition in terms of efficacy, onset of action and dosing convenience.
Luye Pharma has a long-established presence in the central nervous system (CNS) therapeutic area, where it has built a differentiated pipeline of small-molecule class 1 drugs for indications including schizophrenia, depression and Alzheimer's disease. LY03015 is an innovative CNS drug candidate being developed in both China and the U.S. In addition to LY03015, the pipeline includes two candidates currently undergoing phase II clinical trials in China: LY03017, a next-generation 5-HT2AR inverse agonist and 5-HT2CR antagonist intended to treat Alzheimer's disease-related psychosis, Parkinson's disease psychosis, negative symptoms of schizophrenia, major depressive disorder and bipolar disorder; and LY03020, a next-generation antipsychotic and the world's first agonist of both TAAR1 and 5-HT2CR, intended to treat schizophrenia, Alzheimer's disease-related psychosis and bipolar disorder. The pipeline further includes LY03021, a first-in-class GABAAR PAM and NET/DAT inhibitor currently undergoing phase I clinical development in China for the treatment of major depressive disorder.
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 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, with each of them 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 the internationally accepted, GMP-compliant quality management and control systems. To date, the company has launched over 50 products in oncology, the 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.