CSPC PHARMA (01093): Selective 5-HT2A receptor agonist (SYH2056 tablets) receives clinical trial approval in China.

CSPC PHARMA (01093) announced that the group's newly developed Class 1 drug, a selective serotonin 2A receptor (5-HT2A receptor) agonist (SYH2056 tablets), has been approved by the National Medical Products Administration of the People's Republic of China for clinical trials in China. This product is a selective 5-HT2A receptor agonist that improves the disease state of patients with depressive disorders by activating this receptor. It works quickly with a single dose, has long-lasting effects, and does not pose a risk of hallucinations. The approved clinical indication for this product is for the treatment of depression. Preclinical studies have shown that the product effectively promotes dendrite and dendritic spine formation in central neurons, leading to neural remodeling. In various depression animal models, the product has shown excellent anti-depressant activity and significantly reduces the risk of hallucinations associated with its target, while also demonstrating good pharmacokinetic (PK) characteristics and safety, making it potentially the best-in-class anti-depressant. Currently, the group has submitted multiple patent applications for this product domestically and internationally. Given the shortcomings of traditional anti-depressant drugs that cannot be overcome in clinical treatment, and the lack of new mechanism drug treatments for depressive disorders, this product has a broad clinical demand and high clinical development value.