Core Viewpoint - The company has received approval from the U.S. Food and Drug Administration (FDA) for its novel chemical drug SYH2056, a selective 5-HT2A receptor agonist, to conduct clinical trials in the U.S. [1] - The product has also been approved by the National Medical Products Administration (NMPA) of China for clinical trials starting in November 2025 [1] Group 1 - SYH2056 is designed to improve the condition of patients with depressive disorders by activating the 5-HT2A receptor, providing rapid onset of action with lasting effects and no hallucinogenic risks [1] - The clinical indication for this product is specifically for the treatment of depression [1] - Preclinical studies indicate that SYH2056 effectively promotes the generation of dendrites and dendritic spines in central nervous neurons, demonstrating neuroplasticity effects [1] Group 2 - In various animal models of depression, SYH2056 has shown excellent antidepressant activity while significantly reducing the potential hallucinogenic risks associated with the target [1] - The product exhibits favorable pharmacokinetic (PK) characteristics and safety, positioning it as a potential best-in-class antidepressant [1] - The company has submitted multiple patent applications for this product both domestically and internationally [1]
石药集团(01093.HK)：选择性5-HT2A受体激动剂“SYH2056片”在美国获临床试验批准