ST Wanbang: Subsidiary's Neonatal HIE New Drug WP103 Receives US FDA Feedback

ST Wanbang announced that its wholly-owned subsidiary, Wanbangde Pharmaceutical Group Co., Ltd., has received written feedback from the U.S. FDA through a Type B meeting regarding the planned pivotal registration clinical trial for its independently developed WP103. The FDA provided technical opinions on the Phase II clinical trial protocol and clarified the subsequent development pathway: after the company completes two animal studies, revises the clinical protocol, and obtains further FDA concurrence, it may proceed to initiate the clinical trial, with the study data intended to support a New Drug Application. The drug has previously received Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. FDA. This progress will not have a material impact on the company's operating performance in the short term.