万邦德：WP107药品临床试验申请获FDA受理

Group 1 - Company announced that its subsidiary received a written response from the FDA regarding the clinical trial application for WP107 (Huperzine A oral solution) for the treatment of generalized myasthenia gravis, which was officially accepted on December 14, 2024 [1] - WP107 is an innovative oral formulation developed by the company's research team, showing high activity and selectivity as a cholinesterase inhibitor, with additional immune modulation and antioxidant effects [1] - The new oral solution formulation is designed to be patient-friendly for those with swallowing difficulties, particularly suitable for pediatric myasthenia gravis patients [1] Group 2 - The company received orphan drug designation from the FDA for Huperzine A in treating myasthenia gravis, which provides various regulatory benefits and market exclusivity for seven years post-approval [2] - The orphan drug market is experiencing significant growth, with a projected compound annual growth rate of approximately 12% from 2019 to 2024, reaching a market size of $242 billion by 2024 [2] - The current trend in the innovative drug industry is positive, with an increase in supply and several domestic innovative drugs expected to be approved soon, potentially leading to a new wave of market expansion [2]