HXP056 / Fujian Haixi New Pharmaceutical - LARVOL DELTA

Fujian Haixi Pharmaceuticals Says HX9428 Granted Fast Track Designation By U.S. FDA (TradingView)

Fast track • Ophthalmology

Fujian Haixi Pharmaceuticals…is pleased to announce that the Investigational New Drug Application (the 'IND') of HX9428, the candidate molecule of HXP056…for the treatment of neovascular age-related macular degeneration ( 'nAMD', also called wet age-related macular degeneration ('wAMD')), has been approved by the U.S. Food and Drug Administration (the 'FDA') (HKEXnews) - "This approved IND includes a Phase II clinical trial, aiming to evaluate the efficacy and safety of different oral doses of HX9428 in treating American patients with nAMD. At the same time, the Company officially commenced the second Phase II clinical trial of HX9428 (Registration No.: CTR20262884) for the treatment of nAMD in China, and the related information has been published on the Drug Clinical Trial Registration and Information Disclosure Platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This study is a randomized and positive-controlled Phase II clinical trial further initiated by the Group based on the prior Phase I and Phase II dose expansion studies of HX9428."

IND • New P2 trial • Trial status • Wet Age-related Macular Degeneration

Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD) (clinicaltrials.gov) - P1/2 | N=198 | Recruiting | Sponsor: Fujian Haixi Pharmaceuticals Co., Ltd.

New P1/2 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration