Gyre Therapeutics berencana mengajukan NDA untuk persetujuan bersyarat Hydronidone di China

Setelah penyelarasan dengan CDE China, perusahaan berencana mengajukan NDA untuk persetujuan bersyarat Hydronidone pada fibrosis hati terkait CHB pada paruh pertama 2026. CDE menyatakan bahwa data Phase 3 yang ada mendukung pengajuan persetujuan bersyarat dan potensi kelayakan tinjauan prioritas, tergantung penerimaan formal.

Fakta utama

Diajukan: 12 Mar 2026, 00.00
Peristiwa: Permohonan diajukan
Arah: Positif
Perusahaan: GYREGyre Therapeutics
Aset: hydronidone
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

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