WBDE(SZ:002082) Zheng Quan Shi Bao Wang·2025-01-15 14:20Company Overview - Wanbangde Pharmaceutical Holdings Group Co., Ltd. announced that its wholly-owned subsidiary, Wanbangde Pharmaceutical Group Co., Ltd., received FDA approval for clinical trials of WP107 (Huperzine A oral solution) for the treatment of generalized myasthenia gravis [1] - The company expects a net profit attributable to shareholders of 65 million to 90 million yuan for 2024, representing a year-on-year growth of 32.09% to 82.89% [1] Product Development - WP107 is an innovative oral formulation developed by the company's research team, designed to address swallowing difficulties in some myasthenia gravis patients and improve medication adherence in pediatric patients [1] - The development of WP107 is based on existing pharmacological and clinical data from the company's injectable Huperzine A [1] Market Potential - The myasthenia gravis drug market has significant growth potential, with GlobalData reporting that the market size is expected to grow from $3 billion in 2022 to $6.7 billion by 2032 across seven major global markets [2] - In China, the myasthenia gravis drug market is projected to grow to 1.252 billion yuan in 2024, with a year-on-year increase of 1.6% [2] Regulatory Support - In December 2023, the company received orphan drug designation from the FDA for Huperzine A for treating myasthenia gravis, which provides various policy supports including tax credits for clinical trial costs and seven years of market exclusivity post-approval [3] - The recent FDA clinical trial approval for WP107 marks another significant advancement in the company's new drug development efforts, potentially offering new treatment options for patients and creating market opportunities for the company [3]