Core Viewpoint - The company, Stone Pharmaceutical Group, has received approval from the U.S. Food and Drug Administration (FDA) for its novel chemical entity, SYH2056, a selective 5-HT2A receptor agonist, to conduct clinical trials in the U.S. This product has also been approved by the National Medical Products Administration (NMPA) in China for clinical trials starting in November 2025 [1]. Group 1 - The product SYH2056 is designed to improve the condition of patients with depressive disorders by activating the 5-HT2A receptor, showing rapid onset of action with lasting effects and no risk of hallucinations [1]. - The clinical indication for SYH2056 is the treatment of depression, with preclinical studies demonstrating its effectiveness in promoting dendritic and dendritic spine generation in central nervous neurons, indicating potential for neuroplasticity [1]. - In various animal models of depression, SYH2056 exhibited excellent antidepressant activity while significantly reducing the potential hallucinogenic risks associated with the target, alongside favorable pharmacokinetic (PK) properties and safety, positioning it as a potential best-in-class antidepressant [1]. Group 2 - The clinical demand for SYH2056 is substantial due to the limitations of traditional antidepressants and the lack of new mechanism-based treatments for depressive disorders, highlighting its high clinical development value [1]. - The company has submitted multiple patent applications for SYH2056 both domestically and internationally, indicating a strong commitment to protecting its intellectual property [1].
石药集团(01093)：选择性5-HT2A受体激动剂在美国获临床试验批准