Gyre nagsumite ng NDA para sa F351 (hydronidone) sa fibrosis ng atay na CHB

Gyre Pharmaceuticals nagsumite ng NDA sa CDE ng Tsina noong Marso 2026 na humihiling ng conditional approval para sa F351 sa fibrosis ng atay na may kaugnayan sa CHB. Ang paghahain ay kasunod ng pagkakaloob ng CDE ng priority review designation at kasalukuyang nasa ilalim ng completeness review para sa acceptance.

Mahahalagang fact

Na-file: May 7, 2026, 12:30 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
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 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