CSPC Pharma Initiates Phase II Trial of SYH2085 Tablet for Uncomplicated Influenza in Chinese Adults

Stock News
Sep 07

CSPC Pharma (01093) has announced that the Phase II clinical trial of its SYH2085 tablet, designed for the treatment of uncomplicated influenza in adults, has formally commenced at the first clinical center in China.

The product is a small molecule inhibitor specifically targeting the PA subunit of the influenza virus RNA polymerase, registered as a Class 1 chemical drug. Upon administration, it is converted in the body into the primary 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, in December 2025, the company received the Drug Clinical Trial Approval Notice for this product from China's National Medical Products Administration. Following that approval, the company launched a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of the product in healthy Chinese trial participants.

To date, preliminary data from the Phase I trial have validated its safety profile and its pharmacokinetic and pharmacodynamic properties in humans. The findings also indicate that a single oral dose of the product demonstrates good safety, satisfactory compliance, and a low risk of drug resistance.

The newly initiated Phase II clinical study is designed as a multicenter, randomized, double-blind, placebo-controlled trial. Its primary objective is to assess the efficacy and safety of the product in treating Chinese adult participants with uncomplicated influenza. Currently, participant recruitment and screening for this study are actively underway.

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