CSPC Pharmaceutical gets approval for SYH2085 clinical trials in China

CSPC Pharmaceutical Group announced that its SYH2085 tablets, a Class 1 new chemical drug, have received approval from China's National Medical Products Administration to commence clinical trials. The product is an oral small-molecule candidate designed to inhibit the endonuclease activity of the influenza virus RNA polymerase acidic (PA) protein.

The approved indication for these clinical trials is the treatment of uncomplicated influenza A and B in adults and adolescents aged 12 years and older. Pre-clinical studies demonstrated that SYH2085 exhibits broad-spectrum and potent inhibitory activity against both influenza A and B viruses, effectively reducing viral load and influenza-like symptoms in animal models, coupled with favorable pharmacokinetic properties and a strong safety profile.

This development is expected to provide an effective influenza treatment, enhancing the group's pipeline in the anti-infectives therapeutic area and underscoring its clinical development value. The announcement was made by chairman CAI Dong Chen in Hong Kong on December 19, 2025.