CSPC gets nod for new antidepressant clinical trials in China

CSPC Pharmaceutical Group Limited announced that its selective 5-HT2A receptor agonist, SYH2056 tablets, a Class 1 new chemical drug, has obtained approval from China’s National Medical Products Administration to conduct clinical trials. The product is designed to treat depression by activating the 5-HT2A receptor, offering rapid onset and long-lasting effects without hallucination risk.

Preclinical studies indicate that SYH2056 promotes the formation of dendrites and dendritic spines in central neurons and facilitates neural remodeling. The drug demonstrated excellent antidepressant activity in animal models while significantly reducing potential hallucination risk. It also exhibits favorable pharmacokinetic and safety characteristics, positioning it as a potential best-in-class antidepressant.

CSPC has submitted multiple patent applications for the product both domestically and internationally. The company highlights a significant clinical demand for novel antidepressant therapies, given the limitations of traditional treatments and the lack of new mechanisms for depressive disorders.