Core Viewpoint - The announcement highlights that the pharmaceutical company has received approval from the U.S. Food and Drug Administration (FDA) for its novel Class 1 chemical drug, SYH2056, a selective 5-HT2A receptor agonist, to conduct clinical trials in the U.S. and has also received approval from the National Medical Products Administration (NMPA) in China for clinical trials starting in November 2025 [1] Group 1 - The product is designed to activate the 5-HT2A receptor to improve the condition of patients with depressive disorders, showing rapid onset of action and prolonged efficacy without the risk of hallucinations [1] - The clinical indication for the approved trials is the treatment of depression, with preclinical studies demonstrating effective promotion of dendritic and dendritic spine generation in central nervous neurons, indicating a potential for neuroplasticity [1] - In various animal models of depression, the product has shown excellent antidepressant activity while significantly reducing the potential hallucinogenic risks associated with the target, along with favorable pharmacokinetic (PK) properties and safety, positioning it as a best-in-class antidepressant [1] Group 2 - The clinical demand for this product is substantial due to the numerous clinical treatment inadequacies of traditional antidepressants and the lack of new mechanism drug therapies for depressive disorders, indicating high clinical development value [1]
石药集团：选择性5-HT2A受体激动剂在美国获临床试验批准