Luye Pharma Group Limited (HKG: 2186) announced that its independently developed LY03017 received U.S. FDA permission to conduct clinical trials for Alzheimer’s disease psychosis (ADP), Parkinson’s disease psychosis (PDP), and negative symptoms of schizophrenia (NSS). The drug is a next‑generation 5‑HT2A receptor inverse agonist and 5‑HT2C receptor antagonist also in Phase I trials in China.
Regulatory Milestone
Item
Detail
Product
LY03017
Company
Luye Pharma Group (2186.HK)
Agency
U.S. Food and Drug Administration (FDA)
Approval Type
Clinical trial permission
Indications
ADP, PDP, NSS
China Status
Phase I clinical trials ongoing
Platform
New Molecular Entity/New Therapeutic Entity (NME/NTE)
Drug Profile
Mechanism: Dual action as 5‑HT2A receptor inverse agonist and 5‑HT2C receptor antagonist
Therapeutic Effect: Reduces hallucinations/delusions in ADP/PDP and improves NSS by modulating dopamine release
Inhibits dopamine release in ventral striatum
Promotes dopamine release in prefrontal cortex
Innovation: Next‑generation CNS therapeutic with superior pharmacological activity, tissue distribution, and cardiac safety vs. marketed and investigational competitors (per preclinical data)
Development Strategy: Concurrent development in China and U.S.
~2.8 million schizophrenia patients, ~30% with prominent negative symptoms
CNS Psychosis Market Size
¥12 billion (US$1.6 billion)
Growth CAGR
9% (2024‑2030)
Peak Sales Forecast (LY03017)
¥3.5‑4.5 billion (US$480‑610 million) by 2033
Competitive Landscape:
Acadia’s Nuplazid (approved for PDP only); no approved therapies for ADP or NSS in China
Differentiation: Dual 5‑HT2A/C mechanism offers broader efficacy vs. single‑target agents; superior cardiac safety addresses key Nuplazid liability (QT prolongation)
Strategic Value: Positions Luye as first‑mover in ADP/NSS segments; Phase I data could trigger Breakthrough Therapy Designation in U.S.
Next Catalyst: Interim Phase I safety data Q4 2026
Forward‑Looking Statements This brief contains forward‑looking statements regarding LY03017’s clinical development, regulatory pathway, and market potential. Actual results may differ materially due to risks including clinical trial outcomes, safety profiles, and competitive dynamics in the CNS therapeutics market.-Fineline Info & Tech
By Fineline Cube 