WBDE(SZ:002082) Ge Long Hui·2025-10-31 11:34Core Insights - WP103 is an innovative drug developed by the company for treating neonatal Hypoxic-Ischemic Encephalopathy (HIE) and has received FDA approval for clinical trials starting in January 2025 [1] - The drug has shown promising results in preclinical studies, demonstrating effectiveness in reducing brain injury risk, accelerating neurological recovery, and reversing behavioral deficits [1] - WP103 has received both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA, indicating its innovative value and potential clinical demand in the neonatal HIE treatment space [2] Company Developments - The company has conducted large animal non-clinical pharmacodynamic trials to support the initiation of critical registration clinical studies for HIE, which are essential for bridging basic research and clinical application [1] - The dual designation of RPDD and ODD provides the company with various policy supports, including market exclusivity, exemption from new drug application fees, and expedited review processes, which will facilitate global clinical development and commercialization of WP103 [2] - The company plans to engage in further discussions with the FDA regarding trial results and must conduct a series of clinical trials in compliance with U.S. drug registration regulations before the drug can be marketed [2]