GNI Group Ltd.
Gyre Therapeutics Q3 FY2026 Financial Results and Progress of Regulatory Review for F351
Announcement of Gyre Therapeutics' Q3 FY2026 results and progress of NMPA review for F351 (therapy for liver fibrosis). NMPA on-site inspection completed; approval decision expected late 2026 or Q1 2027.
Key Figures
- F351 regulatory review: NMPA on-site inspection completed; decision timing late 2026 or Q1 2027
- NDA acceptance: May 2026 (NMPA CDE)
- Estimated launch: First half of 2027
AI要約
Summary of Financial Results
Information on Gyre Therapeutics' Q3 FY2026 financial results was released, noting that the Cullgen business was reflected for the full quarter for the first time. The update emphasized development status of key programs including F351 and overall pipeline progress. The company plans to obtain FIH data and initiate new clinical development programs, and is expected to strengthen its unique business model combining operations in the U.S. and China.
Progress of Regulatory Review and Outlook
The NDA for F351 (hydronidone) was accepted by the NMPA's Center for Drug Evaluation (CDE), and an on-site inspection has been completed. The NMPA's approval decision may occur in late 2026 or in Q1 2027, and preparations for a China launch are ongoing. If approved, the drug will be positioned as a new treatment targeting CHB-associated liver fibrosis.
GNI Group Ltd.
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