CSPC PHARMA (01093): The Phase II clinical trial for SYH2085 tablets for the treatment of adult uncomplicated influenza has officially started in China.

CSPC PHARMA (01093) announced that the Phase II clinical trial for SYH2085 tablets, developed by the group for the treatment of adult uncomplicated seasonal influenza, has officially begun at the first center in China. This product is a small molecule inhibitor that targets the PA subunit of the influenza virus RNA polymerase and is classified as a Class 1 chemical drug. The product is metabolized in the body to its main active metabolite, SYH2085A-01207, which selectively inhibits the endonuclease activity of the viral polymerase PA subunit, thereby suppressing the replication of the influenza virus. Previously, on December 2025, the group received a "Drug Clinical Trial Approval Notification" from the National Medical Products Administration of China for this product. After receiving approval, the group initiated a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of the product in healthy participants in China. The preliminary data from the Phase I trial has validated its safety in humans, as well as its pharmacokinetic and pharmacodynamic characteristics. It also demonstrated that the product has good safety with single oral administration, good compliance, and a low risk of resistance. The clinical trial being initiated is a multicenter, randomized, double-blind, placebo-controlled Phase II study aimed at evaluating the efficacy and safety of the product in treating participants with uncomplicated seasonal influenza in Chinese adults. The recruitment and screening of participants for this study are currently being actively promoted.