CSPC PHARMA - VOLUNTARY ANNOUNCEMENT - PHASE I CLINICAL TRIAL OF SYH2056 TABLETS FOR THE TREATMENT OF DEPRESSION OFFICIALLY INITIATED IN CHINA
CSPC PHARMACEUTICAL GROUP LIMITED
石藥集團有限公司
(Incorporated in Hong Kong with limited liability)
(Stock Code: 1093)
VOLUNTARY ANNOUNCEMENT
PHASE I CLINICAL TRIAL OF SYH2056 TABLETS FOR THE TREATMENT
OF DEPRESSION OFFICIALLY INITIATED IN CHINA
The Board of Directors (the 'Board') of CSPC Pharmaceutical Group Limited (the 'Company', together with its subsidiaries, the 'Group') is pleased to announce that a Phase I clinical trial (Study Protocol No.: SYH2056–001) of SYH2056 tablets (the 'Product'), developed by the Group for the proposed treatment of depression, has been officially initiated in China to evaluate the safety, tolerability, and pharmacokinetic profile of a single oral administration as well as the food effect in healthy Chinese participants.
The Product is a small-molecule 5-HT2A partial agonist developed by the Group. While exerting partial agonistic activity at the 5-HT2A receptors, the Product maintains favorable synaptic neuronal plasticity; a single administration has demonstrated antidepressant effects comparable to or better than those of similar products across various animal models. Furthermore, pre-clinical studies demonstrated that the Product had relatively low risks associated with off-target effects, hallucination and drug dependence.
SYH2056–001 is a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic profile as well as the food effect, of a single oral administration of the Product in healthy Chinese participants. It primarily aims to evaluate the safety, tolerability, pharmacokinetic profile and the impact on neuropsychiatric status of healthy participants following a single oral administration of the Product in healthy participants. Currently, the recruitment and screening of participants are actively underway.
By order of the Board
CSPC Pharmaceutical Group Limited CAI Dong Chen
Chairman
Hong Kong, 1 September 2026