Developer · 2186.HK · China
Luye Pharma Group Ltd.
Pharmaceutical company headquartered in Yantai, Shandong, China (HKEX: 2186), focused on CNS and oncology with a long-acting/extended-release drug-delivery platform (microspheres, transdermal, liposomes). CNS portfolio includes Jinyouping (rotigotine extended-release microspheres, LY03003) for Parkinson's disease, Ruoxinlin (ansofaxine, LY03005) for depression in China, and Rykindo (risperidone extended-release microspheres, LY03004), approved in the US and China. A once-monthly rotigotine behenate microsphere follow-on (LY03009) is in development.
Pipeline (1)
- Parkinson's diseaseApprovedApproved
Catalysts · 0 upcoming · 1 reported
Recently reported
- 2022-07-19met
Rotigotine extended-release microspheres (LY03003)forParkinson's diseaseTopline data
Chinese pivotal Phase 3 of weekly LY03003 in early-stage Parkinson's disease (n=294) met its primary endpoint: statistically significant improvement in UPDRS Part II+III vs placebo (p<0.001), significant secondary endpoints, no IMP-related SAEs.
Recent activity
- Jun 20, 2024Phase changeRotigotine extended-release microspheres (LY03003)·Parkinson's diseaseApprovedNMPA approved Jinyouping (rotigotine microspheres for injection) for marketing in China for Parkinson's disease, announced by Luye 2024-06-20 (wire coverage dated the corporate announcement 2024-06-19; the exact NMPA certificate date is not public, so this date is an upper bound). First marketing authorization anywhere for the weekly depot.source ↗
- Aug 1, 2023Phase changeRotigotine extended-release microspheres (LY03003)·Parkinson's diseaseFiled (NDA)China's CDE accepted the NDA for rotigotine extended-release microspheres for injection (LY03003) and granted priority review designation, per Luye's 2023-08-01 announcement. Submission supported by several Phase 1 trials plus the single Phase 3.source ↗
- Jul 19, 2022ReadoutRotigotine extended-release microspheres (LY03003)·Parkinson's diseasemetChinese pivotal Phase 3 of weekly LY03003 in early-stage Parkinson's disease (n=294) met its primary endpoint: statistically significant improvement in UPDRS Part II+III vs placebo (p<0.001), significant secondary endpoints, no IMP-related SAEs.source ↗
- May 11, 2020Phase changeRotigotine extended-release microspheres (LY03003)·Parkinson's diseasePhase 3Pivotal Chinese Phase 3 NCT04571164 started: multicenter, randomized, double-blind, placebo-controlled study of weekly IM LY03003 vs placebo in 294 patients with early primary Parkinson's disease; primary endpoint UPDRS Part II+III.source ↗
- Mar 15, 2013Phase changeRotigotine extended-release microspheres (LY03003)·Parkinson's diseasePhase 1First-in-human tolerance and PK study of LY03003 started (NCT04627155, n=20; registered retrospectively in 2020). A parallel early PK/safety study in early-stage PD patients (NCT02055274) started October 2013.source ↗
Competitive landscape
Other companies developing against Luye Pharma Group Ltd.'s targets or indications.
- Biohaven Ltd.1 compoundParkinson's disease
- Cerevel Therapeutics Holdings, Inc.1 compoundParkinson's disease
- Intra-Cellular Therapies, Inc.1 compoundParkinson's disease
- Kyowa Kirin Co., Ltd.1 compoundParkinson's disease
- NeuroDerm1 compoundParkinson's disease
- Sage Therapeutics, Inc.1 compoundParkinson's disease