Wanbangde New Building Materials Co., Ltd (SHE: 002082), a company operating in China, has announced that its drug candidate, huperzine A, has been granted an orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE). This designation is a significant step towards addressing the unmet medical need for this condition.
Neonatal HIE is a type of brain injury caused by hypoxia of brain tissue and decreased cerebral blood flow in newborns. Existing treatment methods are limited to supportive care, seizure control, management of cerebral edema, and mild hypothermia therapy. Huperzine A operates primarily as an acetylcholinesterase inhibitor and has demonstrated anti-inflammatory, antioxidant, and neuroprotective properties. It is recognized for its potential benefits in improving memory functions, including directional memory, associative learning, image recall, and recognition tasks, as well as alleviating memory disorders associated with dementia and organic brain lesions. Additionally, it has applications in the treatment of myasthenia gravis.
Wanbangde currently markets huperzine A active pharmaceutical ingredients (APIs) and a formulated injection in China, while a controlled-release tablet form is in clinical development. The drug previously received a rare pediatric disease (RPD) designation in the U.S. for the same indication.- Flcube.com
