Plano ng Gyre Therapeutics na magsumite ng NDA para sa conditional approval ng Hydronidone sa Tsina

Kasunod ng pagkakahanay sa CDE ng Tsina, plano ng kumpanya na magsumite ng NDA para sa conditional approval ng Hydronidone sa CHB-associated liver fibrosis sa unang kalahati ng 2026. Ipinahiwatig ng CDE na ang kasalukuyang Phase 3 data ay sumusuporta sa conditional approval filing at potensyal na pagiging karapat-dapat sa priority review, depende sa formal acceptance.

Mahahalagang fact

Na-file: Mar 12, 2026, 12:00 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: GYREGyre Therapeutics
Asset: hydronidone
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 gyre-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Gyre Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Full-year 2025 revenue increased 10% year-over-year to $116.6 million, within revised guidance range Full year 2026 revenue guidance of $100.5 to $111.0 million Entered into agreement to acquire Cullgen to gain targeted protein degradation platform and pipeline; transaction anticipated to close in the second quarter of 2026 Alignment with China’s Center for Drug Evaluation (CDE) on conditional approval filing and priority review eligibility for Hydronidone, subject to formal approval; New Drug Application (NDA) submission for conditional approval expected in the first half of 2026 Completed patient enrollment in the 52-week Pha

SEC 8-K