CSPC Pharmaceutical Group Limited (CSPC Pharma) has commenced a multi-centre, randomised, double-blind, placebo-controlled Phase II clinical trial of its investigational RSV therapeutic SYH2066 tablets at the first site in China.
SYH2066 is a Class 1 small-molecule fusion (F) protein inhibitor designed to block the conformational change required for respiratory syncytial virus (RSV) to fuse with host-cell membranes, thereby preventing viral entry and replication.
Regulatory status and prior data: • The National Medical Products Administration granted a Notice of Approval for Clinical Trial of Drug for SYH2066 in September 2025. • A single-centre Phase I study evaluating single and multiple ascending doses in healthy Chinese participants confirmed a favourable safety and pharmacokinetic profile following oral administration.
Current Phase II objectives: • Assess efficacy and safety in adult patients with confirmed RSV infection. • Participant recruitment and screening are now underway across multiple clinical centres in China.
The Board highlighted that the trial launch marks a key development milestone for CSPC Pharma’s antiviral pipeline, advancing SYH2066 into patient-based efficacy evaluation following encouraging Phase I results.