WBDE(SZ:002082) Zheng Quan Shi Bao Wang·2025-01-19 18:12Core Viewpoint - The company has received FDA approval for clinical trials of its self-developed drug WP103 (Huperzine A injection) for the treatment of neonatal hypoxic-ischemic encephalopathy, marking a significant milestone in its drug development process [1][2]. Group 1: FDA Approval and Drug Information - The FDA granted permission for clinical trials of WP103, which is an innovative drug developed by the company's research team, specifically for treating neonatal hypoxic-ischemic encephalopathy, a condition currently without approved treatments in the U.S. [2] - WP103 is a natural alkaloid with high activity and selectivity as a cholinesterase inhibitor, also exhibiting immunomodulatory and antioxidant properties. Preclinical studies indicate its potential to reduce brain damage and neuronal death in affected infants [2][3]. - The company received Rare Pediatric Disease (RPD) and Orphan Drug Designation (ODD) from the FDA in May 2024, which provides various regulatory and financial benefits, including tax credits for clinical trial costs and seven years of market exclusivity post-approval [2]. Group 2: Clinical Research and Development - The upcoming clinical research for WP103 will focus on pharmacokinetics in healthy individuals, aiming to bridge existing clinical data from Chinese populations to support rapid development for new indications [3].