万邦德子公司药品WP107获得伦理批件

Core Viewpoint - Wanbangde's subsidiary has received ethical approval for the Phase I clinical trial of WP107, a new drug for treating myasthenia gravis, indicating progress in its drug development pipeline [1] Group 1: Clinical Trial Developments - Wanbangde's subsidiary, Wanbangde Pharmaceutical Group, has obtained approval from the ethics committee of Wenzhou Medical University for the Phase I clinical trial of WP107 [1] - The trial aims to compare the pharmacokinetic characteristics of oral and injectable forms of huperzine A in healthy Chinese subjects under fasting conditions [1] - The company received orphan drug designation from the FDA for huperzine A in December 2023, and has been granted clinical trial approval for WP107 in January 2025 [1] Group 2: Regulatory Approvals - The FDA granted clinical trial permission for WP107 in January 2025, with further approval from the National Medical Products Administration for a Class 2 new drug trial in July 2025 [1] - The ethical approval is a significant step in the drug development process, allowing the company to officially commence the Phase I clinical trial [1]