regulatory
confidence high
sentiment neutral
materiality 0.65
Gyre Therapeutics subsidiary submits NDA in China for F351 for CHB-induced liver fibrosis
GYRE THERAPEUTICS, INC.
- Gyre's majority-owned subsidiary Gyre Pharmaceuticals submitted NDA to China's CDE for lead candidate F351 (Hydronidone).
- F351 is for treatment of chronic hepatitis B (CHB)-induced liver fibrosis.
- NDA subject to formatting verification; CDE will issue acceptance number before technical review.
- Company will work with CDE on supplementary materials if requested.