Subsidiary WP107 of Wanbangde Pharmaceutical Holding Group (002082.SZ) obtained FDA approval for new drug clinical trials.

Wanbangde Pharmaceutical Holding Group (002082.SZ) announced that its wholly-owned subsidiary, Wanbangde Pharmaceutical Holding Group Pharmaceutical Group Co., Ltd., received notification from the Food and Drug Administration (FDA) of the United States on January 15, 2025. The company's independently developed WP107 (huperzine A oral solution) for the treatment of "systemic myasthenia gravis" has been granted clinical trial approval. It is reported that WP107 (huperzine A oral solution) is a new oral formulation of huperzine A developed by the company's innovative drug research and development team based on preclinical and clinical data for the treatment of systemic myasthenia gravis. The development of this formulation has taken into consideration the swallowing difficulties some myasthenia gravis patients may have, as well as the medication compliance of pediatric patients. Building upon the pharmaceutical and clinical data basis of the huperzine A injection already on the market, a new oral solution formulation has been designed. Huperzine A is a naturally occurring alkaloid. As a small molecule chemical drug, preclinical studies have shown that huperzine A is a highly active and selective acetylcholinesterase inhibitor, with immunomodulatory and antioxidant effects, and good oral bioavailability. In December 2023, the company received orphan drug designation (ODD) from the FDA for huperzine A in the treatment of myasthenia gravis, allowing the company to enjoy policy support from the United States in research and development, registration, and commercialization, including tax credits for clinical trial expenses, exemption from new drug application fees, accelerated review and approval qualifications, and 7 years of market exclusivity after approval. The clinical trial approval obtained from the FDA for the new drug clinical study is a randomized, double-blind study with a placebo control, aimed at evaluating the safety, pharmacokinetics, and symptomatic improvement of huperzine A oral solution in patients with systemic myasthenia gravis.