CSPC Pharmaceutical Group (01093) has announced that the Phase II clinical trial of SYH2066 tablets, a product developed by the company for the treatment of respiratory syncytial virus (RSV) infection, has been officially initiated at the first research site in China.
The product is a small molecule RSV fusion protein (F protein) inhibitor, classified as a Category 1 chemical drug for registration purposes. It works by binding to and locking the RSV F protein, thereby blocking its conformational changes and preventing it from mediating membrane fusion between the virus and host cells, ultimately stopping the virus from entering host cells to replicate.
Previously, the company obtained the Drug Clinical Trial Approval Notice from the National Medical Products Administration of the People's Republic of China for this product in September 2025. Following approval, a Phase I clinical trial was immediately launched — a single-center, randomized, double-blind, placebo-controlled, single and multiple dose-escalation study evaluating the safety, tolerability, pharmacokinetic characteristics, and food effects of the product in healthy Chinese participants.
To date, the Phase I clinical trial data have preliminarily validated the safety and pharmacokinetic characteristics of the product in humans, with data showing a favorable safety profile for oral administration. The clinical trial now initiated is a multi-center, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of the product in Chinese adult participants with RSV infection. Participant recruitment and screening for this clinical trial are currently being actively advanced.
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