Biotech News

Gyre Therapeutics Announces Alignment with China’s CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting

Catalyst Biosciences (CBIO)Catalyst Biosciences2026-01-05 12:00 ESTFDA / regulatory

Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE, which agreed that the existing Phase 3 clinical data support a conditional approval filing for Hydronidone and priority review eligibility, subject to formal approval. Gyre Pharmaceuticals plans to submit an NDA in the first half of

Catalyst Biosciences

Catalyst Biosciences was a biotechnology company focused on engineered proteins for hemostasis, complement, and related inflammatory biology before becoming a historical ticker. Its story was built around protein-engineering approaches to difficult disease pathways.

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