CSPC PHARMA (01093.HK): Phase II clinical trial of SYH2085 tablets for uncomplicated influenza in adults officially initiated in China

NewTimeSpace News: On 7 September 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) voluntarily announced that the Phase II clinical trial of SYH2085 tablets developed by the group, for the treatment of uncomplicated influenza in adults, had been officially initiated at the first center in China.

The announcement showed that SYH2085 is a small-molecule inhibitor targeting the PA subunit of the influenza virus RNA polymerase, registered as a Class 1 chemical drug. In vivo, the product is converted into its main active metabolite SYH2085A-01207, which selectively inhibits the endonuclease activity of the PA subunit of the viral polymerase, thereby suppressing influenza virus replication.

The group obtained a Clinical Trial Approval Notice from the NMPA for the product in December 2025 and subsequently initiated a Phase I clinical trial evaluating its safety, tolerability and pharmacokinetic profile in healthy Chinese participants. To date, the Phase I data have preliminarily validated the product's safety and its pharmacokinetic and pharmacodynamic characteristics in humans, and have shown good safety, compliance and a low resistance risk following single oral administration. The Phase II study now initiated is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the product in Chinese adults with uncomplicated influenza, with participant recruitment and screening actively underway.

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