WBDE(SZ:002082) Xin Lang Cai Jing·2025-11-20 03:57Core Viewpoint - The company is advancing the development of WP103, an innovative drug targeting Hypoxic-Ischemic Encephalopathy (HIE) in newborns, which currently has no approved treatments globally [1] Group 1: Disease Significance and Market Potential - HIE is a serious neonatal brain injury caused by lack of oxygen and reduced blood flow, leading to high mortality rates and long-term neurological issues such as cerebral palsy and epilepsy, imposing a heavy burden on families and society [1] - The market for HIE treatments is vast, with hundreds of thousands of infants affected annually, and the market capacity is expected to reach $10 billion [1] Group 2: Drug Development Progress - WP103 has received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA, indicating its innovative value and potential for 7 years of market exclusivity, priority review for new drug applications, and exemption from registration fees [1] - Recent large animal efficacy studies have shown WP103's promising therapeutic effects on key indicators, improving behavioral, neurological scores, and brain tissue pathology [1] - The company plans to communicate with the FDA to advance clinical research for HIE following the completion of preclinical studies [1] Group 3: Company Strategy and Expertise - The company has focused on HIE as a breakthrough area due to the lack of available treatments and urgent clinical needs, supported by a dedicated R&D team of approximately 120 members [1] - The company has established high-end platforms, including a postdoctoral workstation and an academician workstation, and has closely collaborated with the FDA to design non-clinical studies, which has been crucial for the rapid advancement of the project [1]