other material
confidence high
sentiment positive
materiality 0.60
F351 Phase III enrollment completed ahead of schedule for HBV liver fibrosis
GYRE THERAPEUTICS, INC.
- Beijing Continent completed subject enrollment for F351 Phase III trial in China, more than two months ahead of initial expectation.
- Trial aims to confirm efficacy of F351 for liver fibrosis associated with chronic hepatitis B; safety comparable to Phase II.
- F351 received Breakthrough Therapy designation from NMPA in 2021; top-line data expected after 52-week data collection.
- BC, the trial sponsor, will become a subsidiary of Catalyst Biosciences per prior October 24 disclosure; no change to GNI consolidation.