Wandet Pharmaceutical Group's WP107 (Huperzine A Oral Solution) clinical trial application has been accepted by the U.S. FDA!

Recently, the clinical trial application for WP107, a novel oral formulation of huperzine A—an acetylcholinesterase inhibitor and a key product of our company—for the treatment of generalized myasthenia gravis, has been accepted by the U.S. Food and Drug Administration (FDA) and has now entered the expert review phase.

Since receiving the FDA’s Orphan Drug Designation (ODD) for Huperzine A in December 2023 for the treatment of myasthenia gravis, the company’s dedicated R&D team has been working tirelessly to complete all preclinical studies necessary to support the initiation of a U.S. clinical trial. These efforts include international pharmaceutical research on the active pharmaceutical ingredient, development and optimization of a novel oral solution formulation, rigorous pharmacological and toxicological assessments, as well as meticulous planning and drafting of clinical strategies and protocols. Additionally, the team has meticulously prepared for international regulatory submissions and registration processes. Notably, the company has assembled a robust, highly skilled, and fully specialized R&D workforce, enabling it to independently carry out the majority of the project’s R&D activities under the WP107 initiative. Collaborating closely with renowned domestic and international expert teams across various disciplines, the company has leveraged its collective strengths to ensure the project progresses smoothly, efficiently, and at an exceptional quality level.

The successful acceptance of the U.S. FDA's new drug clinical trial application marks another significant milestone in the company's transformation and upgrade toward innovative pharmaceuticals, following its receipt of orphan drug designation. Moving forward, the company will continue to aggressively advance the research and development of cutting-edge therapies and expand its global footprint, striving to deliver safer, more effective clinical treatment options to patients—and ultimately creating exceptional value in health, society, and business.

Adhering to the R&D philosophy of "Patient-Centric, Globally Focused, and Future-Driven," the global clinical development of WP107 Oral Solution truly embodies the company's down-to-earth commitment to delivering high-quality medicines. Backed by FDA orphan drug designation—particularly the exclusive 7-year market exclusivity granted in the U.S.—the product deliberately avoids pursuing cutting-edge dosage forms, instead opting for the most patient-friendly oral solution. This decision was made with careful consideration of the swallowing challenges often faced by myasthenia gravis patients, as well as the medication-handling capabilities and adherence levels of a significant number of pediatric patients. Leveraging the company’s existing expertise in huperzine A injection formulation and manufacturing processes, WP107 efficiently scaled up from pilot production to clinical batch manufacturing, achieving robust stability data along the way. By capitalizing on the company’s strong technical and manufacturing capabilities in both active pharmaceutical ingredients and finished dosage forms, WP107 successfully completed all necessary regulatory tasks—including compliance with FDA and ICH guidelines—in less than one year, showcasing Wanbangde’s remarkable speed in innovative drug development.

The company looks forward to receiving FDA approval for the clinical trial, enabling a swift advancement of WP107’s clinical research and bringing this promising treatment to patients—both domestically and internationally—who are severely affected by myasthenia gravis.

Huperzine A primarily works by inhibiting acetylcholinesterase, while also exhibiting anti-inflammatory, antioxidant, and neuroprotective effects. Due to its well-defined mechanism and favorable safety profile, it holds promise for offering patients with myasthenia gravis a superior clinical treatment option.

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

This IND submission marks another significant achievement for the company as it actively expands into new therapeutic areas for huperzine A, further advancing this innovative, China-originated drug toward global recognition. It also serves as a key component of the company's strategic, forward-looking approach to developing novel formulations, exploring additional indications, and targeting new markets for huperzine A.

Myasthenia gravis (MG) is a rare, chronic autoimmune neuromuscular disorder that can be severe and life-threatening, often leading to disability due to muscle weakness—and in some cases, even death from respiratory failure. The clinical severity of MG can range from mild ocular symptoms, such as drooping eyelids or double vision, to life-threatening conditions like respiratory and bulbar crises, which may require intensive care, ventilatory support, and enteral feeding. Other common symptoms 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 extremities. Notably, about 20% of patients experience only ocular symptoms (known as ocular myasthenia gravis), while the remaining individuals with generalized myasthenia gravis (gMG) also suffer from muscle weakness affecting other areas of the body. Globally, the prevalence of MG is estimated at 12.4 cases per 100,000 people. In the United States, the Myasthenia Gravis Foundation estimates that the disease affects approximately 14 to 20 out of every 100,000 people—equivalent to roughly 36,000 to 60,000 cases nationwide. However, a 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. It’s important to note, though, that MG remains underdiagnosed in many cases, meaning the actual number of people living with the condition could be even higher than these estimates suggest.

The company’s oral solution of huperzine A holds promise in offering patients a treatment option with longer-lasting efficacy and improved safety. Globally, the myasthenia gravis treatment market is projected to exceed $6.7 billion by 2032 [ref], with North America accounting for the largest share of this market.