Gyre mengajukan NDA untuk F351 (hydronidone) pada fibrosis hati CHB

Gyre Pharmaceuticals mengajukan NDA ke CDE China pada Maret 2026 untuk mencari persetujuan bersyarat F351 pada fibrosis hati terkait CHB. Pengajuan ini menyusul pemberian penetapan tinjauan prioritas oleh CDE dan saat ini sedang dalam tinjauan kelengkapan untuk penerimaan.

Fakta utama

Diajukan: 7 Mei 2026, 00.30
Peristiwa: Permohonan diajukan
Arah: Netral
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 First Quarter 2026 Results and Provides Business Update Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10) Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China’s CDE in March 2026 Completed acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding pipeline into inflammatory diseases and cancers First patient enrolled in Phase 2/3 trial evaluating ETUARY TM for radiation-induced lung injury, including immune-related pneumonitis SAN DIEGO, May 7, 2026 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (Gyre, the Company or Gyre Therapeutics) (Nasdaq: GYRE), an innovative, commercial

SEC 8-K