LUYE PHARMA(02186.HK): Innovative Drug LY03015 Completes Bridging Clinical Trial in the US, Pivoting to Efficacy‑focused Clinical Study

NewTimeSpace News: Luye Pharma (02186.HK) released a voluntary announcement on 5 August 2026. LY03015, the world’s first VMAT2 inhibitor / Sigma‑1R agonist independently developed by the Company, has completed its bridging clinical trial in the US to support the forthcoming efficacy‑focused clinical study. The study demonstrates no ethnic differences in pharmacokinetic profiles between Caucasian and Chinese subjects. Overall safety and tolerability were favourable. The TEAE incidence among Caucasian subjects stood at 33.3%, versus 83.3% for Chinese subjects, showing better safety and tolerability in Caucasian participants.

The earlier Chinese Phase II trial enrolled 121 patients with moderate‑to‑severe TD. The AIMS response rate for the 20mg LY03015 dose group hit 76.5%, nearly doubling historical data of current first‑line therapies. According to the Company, the upcoming US efficacy trial will adopt a simplified dosing regimen, expected to deliver differentiated value in efficacy, onset of action and dosing convenience. LY03015 is targeted for tardive dyskinesia and Huntington’s‑disease‑related chorea. The Company is simultaneously advancing multiple CNS innovative drugs covering schizophrenia, depression, Alzheimer’s disease and other indications.

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