Zhitong Finance App News, Wanbond (002082.SZ) issued an announcement. Wanbond Pharmaceutical Group Co., Ltd., a wholly-owned subsidiary of the company, received a letter of approval from the US Food and Drug Administration (“FDA”) on May 28, 2024. The treatment of neonatal hypoxic ischemic encephalopathy (HIE) was certified as an orphan drug by the FDA.

According to reports, the main mechanism of action of Huperzine A is acetylcholinesterase inhibition, and also has anti-inflammatory, antioxidant stress, and neuroprotective effects. It is suitable for benign memory disorders, improving patients' ability to point memory, associative learning, image recall, meaningless graphics, and portrait recall. It also improves memory impairment caused by dementia patients and organic brain lesions, and is also used in the treatment of myasthenia gravis.

According to the announcement, the company's Huperzine A APIs and Huperzine A injections have now been marketed for sale, and huperzine A controlled-release tablets have entered the clinical trial stage. The current FDA orphan drug qualification for the treatment of neonatal hypoxic ischemic encephalopathy is another important step forward after Huperzine A obtained FDA orphan drug qualification for myasthenia gravis and the FDA's “rare pediatric disease” drug qualification for treating neonatal hypoxic ischemic encephalopathy. This certification will help accelerate the company's drug internationalization strategy.