Good News | Wanbangde Pharmaceutical Group’s Huperzine A Granted Orphan Drug Designation by the U.S. FDA for the Treatment of Neonatal Hypoxic-Ischemic Encephalopathy!

Huperzine A primarily works by inhibiting acetylcholinesterase, while also exhibiting anti-inflammatory, antioxidant, and neuroprotective effects. It is indicated for mild cognitive impairment, helping to enhance patients' abilities in areas such as prospective memory, associative learning, image recall, recognition of meaningless patterns, and autobiographical memory. Additionally, it has shown promise in improving memory deficits caused by dementia and brain-organic lesions, and is also used in the treatment of myasthenia gravis. Due to its well-defined mechanism and favorable safety profile, Huperzine A has been extensively studied in clinical trials worldwide, with applications spanning conditions like Alzheimer’s disease, mild to moderate traumatic brain injury, schizophrenia, epilepsy, and more.

Wanbangde Pharmaceutical Group holds the approval number for Huperzine A API and is a leading domestic supplier of this key active pharmaceutical ingredient. The company also sells Huperzine A Injection and is collaborating with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, to develop an extended-release tablet formulation of Huperzine A—currently undergoing clinical trials for Alzheimer’s disease patients.

This FDA orphan drug designation, part of the company's strategic effort to strengthen intellectual property protection for huperzine A, will further bolster and safeguard the company's innovative initiatives aimed at developing new formulations, exploring additional therapeutic applications, and entering emerging markets for huperzine A.

Neonatal HIE is a type of brain injury in newborns caused by oxygen deprivation and reduced cerebral blood flow. It can occur prenatally (due to conditions like low blood pressure, severe hypoxia, or infections such as chorioamnionitis), perinatally (from events like umbilical cord compression or prolapse, placental abruption or insufficiency, or uterine rupture), or postnatally (in cases of shock, respiratory arrest, or cardiac arrest). Neonatal HIE has profound effects on the developing brain, often leading to significant mortality and morbidity rates, as well as a range of permanent neurological sequelae—including cognitive impairments, forms of cerebral palsy, intellectual disabilities, learning disorders, and epilepsy.

According to reports, the incidence of HIE in China is approximately 3 to 6 cases per 1,000 newborns, meaning that over 50,000 infants are estimated to be affected each year. In the United States, newborn HIE impacts roughly 5,000 to 10,000 babies annually. Globally, about 750,000 infants develop moderate to severe HIE every year, resulting in approximately 400,000 infants who go on to suffer from neurodevelopmental disabilities.

When neonatal HIE occurs, it leads to brain edema and damage to brain tissue. The condition particularly affects the cerebral cortex, hippocampus, striatum, and thalamus. At the molecular level, hypoxic-ischemic (HI) injury triggers a dynamic and destructive cascade of biochemical events, which unfold in distinct phases over days or weeks. Within minutes after the onset of hypoxia and ischemia, the brain experiences a severe shortage of oxygen and glucose, causing intracellular adenosine triphosphate (ATP) levels to plummet. This results in the failure of the sodium-potassium (Na+/K+) pump, glutamate spillage, and a subsequent rise in cytoplasmic calcium ion (Ca2+) concentrations—initiating a series of downstream toxic cascades. Additionally, excessive reactive oxygen species are generated, leading to oxidative stress, intracellular calcium overload, and ultimately, neuronal damage.

Currently, there are no approved drugs available globally for treating neonatal HIE, nor does a comprehensive, standardized treatment protocol exist. While supportive, symptom-specific care remains the cornerstone of management, therapeutic hypothermia (TH) is currently recognized as the safest and most effective neuroprotective intervention for improving outcomes in newborns with HIE—and it has become the standard clinical approach in developed countries. For moderate to severe cases of HIE, when administered alongside optimal supportive care, including assisted ventilation and cardiovascular support, TH is the only proven therapy to date that significantly reduces both infant mortality and long-term neurological damage. However, despite the clear benefits of TH when properly applied to eligible newborns, infants with moderate or severe HIE who undergo this treatment still face devastating complications: 48% experience either death or moderate-to-severe disability, with a mortality rate of 28%, cognitive impairments in 24%, cerebral palsy in 22%, epilepsy in 19%, and cortical visual impairment in 6%. Importantly, TH is a high-risk procedure typically reserved for moderate-to-severe cases, and its implementation can sometimes be delayed due to uncertainties about whether a particular infant qualifies—a delay that may ultimately lead to even greater harm. Thus, while there remains an urgent need for safe and effective treatments for neonates experiencing HIE, there is also a critical gap in developing reliable pharmacological therapies specifically tailored for mild cases of HIE that are not suitable for TH.

About Wanbande Pharmaceutical Group Co., Ltd.

Founded in 1970 and headquartered in Wenling City, Taizhou, Zhejiang Province, Wanbangde Pharmaceutical Group is a high-tech enterprise dedicated to the research, development, manufacturing, and sales of modern Chinese medicines, chemical APIs, and pharmaceutical preparations. With a registered capital of 360 million yuan, the company currently operates six subsidiaries and holds 185 approved drug production licenses covering 14 dosage forms. Wanbangde has consistently earned recognition as one of "China's Top 50 Fastest-Growing Companies in the Pharmaceutical Industry," a "Top 100 Brand Enterprise in Traditional Chinese Medicine," a "Most Promising Growth Enterprise in China's Pharmaceutical Industry," and one of "China's Top 100 Manufacturers of Traditional Chinese Medicines." Additionally, the company's registered trademark has been officially recognized as a China Well-Known Trademark.

Guided by the pharmaceutical R&D philosophy of "patient-centric, globally oriented, and future-focused," the company is not only committed to enhancing the market competitiveness of its generic drug formulations and active pharmaceutical ingredients through differentiated development but also plans to strategically advance both Class 1 new drugs (new chemical entities) and Class 2 new drugs developed via the 505(b)(2) pathway. Additionally, Wanbangde Pharmaceutical Group is actively pursuing global partnerships to accelerate drug discovery and innovation, paving the way for expanding into overseas markets and bringing life-changing treatments to a broader patient population. This comprehensive strategy aims to deliver safer, more effective clinical options to meet the growing demands of patients worldwide.

Statement: 1. This news item is intended to share cutting-edge academic developments and is provided solely for reference by healthcare professionals for academic purposes—not for advertising. 2. Wanbangde Pharmaceutical does not endorse any specific medications and/or indications.