Good News | Wanbangde Pharmaceutical Group’s WP107 (Huperzine A Oral Solution) Receives U.S. FDA Approval for Clinical Trials

WP107 is a novel oral solution formulation of Huperzine A, specifically designed for patients with myasthenia gravis who may experience swallowing difficulties, as well as for pediatric patients. As a highly potent and selective cholinesterase inhibitor, Huperzine A also exhibits immunomodulatory and antioxidant stress-reducing properties, while demonstrating excellent oral bioavailability. Clinical studies have shown that Huperzine A offers significant advantages in treating myasthenia gravis, including good safety profiles, rapid onset of action, pronounced efficacy, and long-lasting therapeutic effects.

The FDA-approved clinical trial is a placebo-controlled, randomized, double-blind study designed to evaluate the safety, pharmacokinetics, and clinical efficacy of WP107 in patients with generalized myasthenia gravis. In December 2023, the company received the FDA’s Orphan Drug Designation (ODD) for huperzine A as a treatment for myasthenia gravis, granting the company access to several U.S. policy incentives throughout the drug development, regulatory approval, and commercialization processes. These benefits include tax credits for clinical trial expenses, waivers of New Drug Application fees, and eligibility for accelerated review and approval. Once the product is approved, it will enjoy a 7-year period of market exclusivity.

Wanbangde Pharmaceutical will continue to advance this R&D project, actively preparing for and initiating the clinical studies, with the goal of bringing WP107 to market as soon as possible—and delivering this groundbreaking therapy, which holds significant clinical potential, to myasthenia gravis patients worldwide.

Huperzine A primarily works by inhibiting acetylcholinesterase, while also exhibiting anti-inflammatory, antioxidant, and neuroprotective effects. Due to its remarkable efficacy, rapid onset of action, prolonged duration of effect, and excellent safety profile, it holds promise as an enhanced clinical option for patients with myasthenia gravis.

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’s domestically produced Huperzine A injection has already been launched, while its Huperzine A controlled-release tablets are currently undergoing clinical trials for the treatment of Alzheimer’s disease.

The recent FDA approval of the IND marks another significant milestone for the company as it actively expands into new therapeutic areas for huperzine A, further advancing this innovative, China-originated drug on the global stage. This achievement also serves as a key component of the company’s strategic initiative to develop novel formulations, explore additional indications, and tap into new markets for huperzine A.

Myasthenia gravis (MG) is a rare, chronic autoimmune neuromuscular disorder that can lead to disabling muscle weakness—and in severe cases, even death due to respiratory failure. The clinical severity of myasthenia gravis can range from mild ocular symptoms, such as drooping eyelids or double vision, to life-threatening conditions like respiratory and bulbar crises, often requiring intensive care, ventilatory support, and enteral feeding. Additional symptoms may include difficulty making facial expressions, swallowing, or speaking—resulting from weakness in the facial muscles—as well as muscle weakness in other parts of the body, such as the neck, upper limbs, and lower limbs. Approximately 20% of patients experience only ocular muscle weakness (known as ocular myasthenia gravis), while the remaining 80%, classified as generalized myasthenia gravis (gMG), also suffer from weakness affecting other areas of the body. Globally, the prevalence of MG is estimated at 12.4 cases per 100,000 people. Meanwhile, the Myasthenia Gravis Foundation of America estimates that the prevalence in the U.S. ranges from 14 to 20 cases per 100,000 individuals, translating to roughly 36,000 to 60,000 cases nationwide. However, a more recent report suggests that the true prevalence in the U.S. may be significantly higher, reaching as high as 37.0 cases per 100,000 people—meaning the total number of affected individuals in the country could exceed 124,000. ¹ However, since MG remains underdiagnosed, the prevalence in the real world may still be higher.

Our company’s Huperzine A oral solution is expected to offer patients a treatment option with significant efficacy and improved safety. Globally, the myasthenia gravis treatment market is projected to exceed $6.7 billion by 2032. ² , with North America being the largest market for myasthenia gravis.

Wanbangde Pharmaceutical Group Co., Ltd. (hereinafter referred to as the "Company") was founded in 1970 and is headquartered in Wenling City, Taizhou, Zhejiang Province. It is a high-tech enterprise dedicated to the research, development, manufacturing, and sales of modern Chinese medicines, chemical APIs, and pharmaceutical preparations. The Company serves as the core subsidiary of Wanbangde Pharmaceutical Holdings Group Co., Ltd., a publicly listed company (stock code: 002082).

The company takes "Healthy China" as its benchmark and consistently adheres to an integrated approach that combines industry, academia, and research. It boasts a well-established technology transfer platform, including prestigious credentials such as the "Provincial Key Academician Workstation," the "Zhejiang Provincial Cardiovascular and Cerebrovascular Drug Enterprise Research Institute," the "Zhejiang Provincial Enterprise Technology Center," the "Zhejiang University School of Pharmaceutical Sciences–Wanbangde Joint Research Center," the "Zhejiang University of Technology–Wanbangde–Drug Innovation Joint R&D Center," the "Zhejiang University Taizhou Institute Pharmaceutical & Health Center–Wanbangde Pharmaceutical Group Co., Ltd. Drug Development Joint Laboratory," and "China's First Collaborative Innovation Alliance for Medical-Research-Industry Integration in Pharmaceutical Products—the Ginkgo Leaf Droplet Pill Medical-Research-Industry Innovation Alliance." Additionally, the company has actively contributed to drafting multiple national pharmacopoeia standards and has secured 28 patents to date.

Currently, the company has established a product portfolio characterized by natural herbal medicines, with a primary focus on cardiovascular, cerebrovascular, and nervous system medications, complemented by therapies for respiratory and other therapeutic areas. Its product lineup spans multiple treatment fields, including cardiovascular, neurological, respiratory, and digestive diseases, and it boasts two core products under its full intellectual property rights: the world’s first-ever huperzine A raw material and injectable solution, as well as the domestically exclusive Ginkgo Biloba Dropping Pills.