Good News | Wanbangde Pharmaceutical Group's WP103 (Huperzine A Injection) Receives U.S. FDA Approval for Clinical Trials

HIE is a neonatal brain injury condition caused by oxygen deprivation and reduced cerebral blood flow in newborns, severely impacting the developing brain and often leading to significant mortality and morbidity rates. In the United States, HIE affects fewer than 10,000 infants each year; globally, approximately 750,000 infants are diagnosed with moderate or severe HIE annually, resulting in around 400,000 infants who go on to develop neurodevelopmental disorders.

Currently, there are no approved drugs available in the U.S. for treating neonatal HIE. In developed countries, the standard intervention for moderate-to-severe neonatal HIE remains therapeutic hypothermia (TH), yet even newborns with moderate-to-severe HIE who undergo TH still face devastating complications—48% experience either death or moderate-to-severe disability. Therefore, there is an urgent need for safe and effective treatments when HIE occurs in newborns, as well as for mild cases of HIE that are not suitable for TH, where alternative drug therapies are critically needed.

This time, the company’s IND approval was based on high-quality preclinical pharmaceutical (API and formulation) and pharmacology/toxicology studies conducted by its R&D and technical teams—studies that fully met FDA and ICH requirements. Combined with existing human-use experience and safety data, the FDA issued a "Study May Proceed" notification, signaling that clinical trials can now move forward.

Our company’s Huperzine A Injection is poised to offer patients a treatment option that delivers significant therapeutic efficacy with excellent safety profiles. WP103 is a small-volume, water-based Huperzine A injection specifically designed for infants experiencing perinatal hypoxia-ischemia. As a highly active and selective cholinesterase inhibitor, Huperzine A also exhibits immunomodulatory, antioxidant stress-reducing, and neuroprotective effects, while demonstrating favorable bioavailability in the brain.

Preclinical studies have shown that in a neonatal HIE model, huperzine A injection not only improves cognition, memory, and motor skills in a dose-dependent manner, but also significantly reduces infarct size and brain injury. Additionally, it markedly decreases neuronal death caused by hypoxia-ischemia.

In late April 2024, the company received the FDA’s Rare Pediatric Disease Designation (RPDD) for huperzine A as a treatment for neonatal hypoxic-ischemic encephalopathy (HIE)—a rare pediatric condition. Just one month later, in late May 2024, the company also secured the FDA’s Orphan Drug Designation (ODD) for the same indication, further underscoring huperzine A’s significant clinical potential. As one of only a few drugs globally to earn both designations from the FDA, this dual recognition not only highlights huperzine A’s high commercial value but also unlocks critical benefits: a 7-year period of market exclusivity starting from drug approval, priority review status for the New Drug Application (NDA), and exemption from NDA filing fees (valued at approximately RMB 30 million). Additionally, the designation provides the company with enhanced access to FDA guidance and support throughout the drug’s clinical development, accelerating efforts to bring much-needed therapies to children battling HIE—a severe, life-threatening pediatric rare disease.

This submission focuses on the neonatal HIE indication—a severe condition that often leads to infant mortality or profound disabilities. Currently, there are no approved treatments for HIE in the U.S., highlighting a critical unmet clinical need. The company is eager for the efficacy and safety of huperzine A to be swiftly validated in clinical settings, ultimately addressing the global demand for effective HIE therapies. We look forward to receiving positive feedback from the FDA regarding the clinical trial application, enabling us to advance WP103 toward rapid, high-quality clinical development—and, ultimately, bringing improved treatment options to the millions of infants and families worldwide who face the threat of HIE.

Wanbangde Pharmaceutical will continue to advance this R&D project, actively preparing for and initiating the clinical studies. We are committed to bringing WP103 to market as soon as possible, offering children and their families worldwide—those urgently in need of safe, effective treatments—a therapeutic option that delivers significant clinical benefits.

Currently, Wanbangde has established an R&D team of approximately 120 members, capable of conducting pharmaceutical research across the entire value chain—from early-stage design, chemistry, and biology, to IND-enabling pharmaceutical and pharmacological/toxicological studies, as well as clinical development planning and operations. Meanwhile, the company boasts several cutting-edge platforms, including an academician workstation, a postdoctoral workstation, and a provincial-level technology and R&D center, providing robust talent and expert support for drug innovation.

The company boasts a robust R&D pipeline, featuring a comprehensive and integrated R&D system that simultaneously advances innovative drug development, generic drug research, active pharmaceutical ingredient (API) development, and traditional Chinese medicine innovation. Among these efforts, the innovative drug program is strategically focused on four key therapeutic areas: major neurological disorders, metabolic conditions, autoimmune diseases, and rare diseases. By leveraging the company’s extensive historical data accumulation, we aim to deliver cutting-edge therapies that address critical unmet clinical needs for patients.

Leveraging years of data accumulation and deep insights from extensive datasets, the Wanbangde innovative drug team has globally pioneered the recognition of Huperzine A for treating neonatal HIE under both ODD and RPDD frameworks. In a remarkably short timeframe, they successfully completed high-quality preclinical studies and promptly secured FDA IND approval, showcasing their exceptional drug development capabilities and demonstrating a strong commitment to accelerating solutions that address critical patient needs.