GNI Group Ltd.
Regarding Future Approval Application Policy Following Completion of Prior Consultation for F351 Priority Review
Consolidated subsidiary Gyre Therapeutics has completed prior consultation with China's CDE and confirmed that NDA submission utilizing the conditional approval system for F351 is possible and qualifies for priority review. NDA submission is targeted for the first half of 2026.
Key Figures
- Scheduled NDA Submission Period: First half of 2026
- F351 Phase 3 Clinical Trial Results: Favorable results
- Priority Review Eligibility: Yes (Breakthrough Therapy Designation)
AI要約
Completion of Prior Consultation and Future Approval Application Policy
Gyre Therapeutics, a consolidated subsidiary of GNI Group, Inc., has completed prior consultation with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China regarding the new drug application (NDA). As disclosed on May 23, 2025, the Phase 3 clinical trial of F351 showed favorable results, and it was confirmed during this consultation that submitting an NDA under the conditional approval system is possible and that the product qualifies for priority review. F351 was designated as a breakthrough therapy in 2021, which is expected to shorten the review period.
Upcoming Schedule and Outlook
Gyre Therapeutics aims to submit the NDA in the first half of 2026 and is preparing confirmatory clinical trials for the transition from conditional approval to full approval. The company will promptly disclose any important related information as it arises. This is expected to accelerate the progress of product development and market launch.
