Currently, no pharmaceutical product containing Huperzine A has been approved for marketing in the USA, and there are no approved drugs globally for the treatment of neonatal HIE. Multiple preclinical studies have shown significant potential for Huperzine A in treating neonatal HIE, with hopes of addressing hypoxic-ischemic pathophysiological challenges through integrated mechanisms.
The Star Daily (Reporter Qiu Siyu) reported that this evening (December 17), Wanbangde Pharmaceutical Holding Group's subsidiary WP103's clinical trial application was accepted by the FDA.
Wanbangde's announcement revealed that its subsidiary received a written reply from the FDA on December 17, 2024, confirming the acceptance of the clinical trial application for WP103 (Huperzine A injection) for the treatment of neonatal hypoxic-ischemic encephalopathy (HIE).
WP103 (Huperzine A injection) is developed by Wanbangde's Innovative Drugs R&D team based on preclinical and clinical data, meeting FDA requirements for treating neonatal hypoxic-ischemic encephalopathy. Currently, no Huperzine A pharmaceutical product has been approved for marketing in the USA, and there are no approved drugs globally for the treatment of neonatal HIE.
It is reported that neonatal HIE is a form of neonatal brain injury caused by hypoxia of brain tissue and reduced cerebral blood flow. In the USA, HIE affects approximately 0.01 million infants annually; globally, about 0.75 million infants suffer from moderate to severe HIE each year, resulting in around 0.4 million infants experiencing neurodevelopmental disorders. Current treatment options include supportive therapy, seizure control, treatment of cerebral edema, and hypothermia therapy.
Huperzine A is a high-activity, highly selective acetylcholinesterase inhibitor, which also possesses immunomodulatory and antioxidant stress effects.
Multiple preclinical studies have indicated that Huperzine A treatment is expected to address hypoxic-ischemic pathophysiological challenges through integrated mechanisms, including increasing cholinergic levels, reducing excitotoxicity, improving mitochondrial dysfunction, lowering inflammation, and decreasing pro-inflammatory cytokines (IL-6, TNF-α, and IL-1β), reducing oxidative stress, and minimizing neuronal death.
Additionally, just two days ago (December 15), Wanbangde's subsidiary WP107's drug clinical trial application was also accepted by the FDA. WP107 is an oral solution of Huperzine A, with the accepted indication for generalized myasthenia gravis.
Wanbangde Pharmaceutical Holding Group's main business is in the research, development, production, and sales of Pharmaceuticals and medical instruments. In the first three quarters of this year, the company achieved revenue of 1.074 billion yuan, a year-on-year growth of 5.56%; the net income attributable to the parent company was 45.706 million yuan, marking a turnaround from losses year-on-year.
In the pharmaceutical field, in addition to the aforementioned WP103 and WP107, Wanbangde's main research drugs include Huperzine A controlled-release tablets, Lizhong Xiaopi granules, Chlorpromazine tablets, and Cimetidine tablets; in the medical instruments field, Wanbangde's main products and services include Medical Devices and hospital engineering services, disposable sterile medical polymer consumables, and orthopedic implant instruments.
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