GYRE · Gyre Therapeutics, Inc.

Summary

Gyre Pharmaceuticals Co., Ltd., Gyre Therapeutics, Inc.’s majority indirectly owned subsidiary, submitted a New Drug Application to the Center for Drug Evaluation of China’s National Medical Products Administration for F351 (Hydronidone), its lead product candidate, for chronic hepatitis B-induced liver fibrosis on March 22, 2026. The submission is subject to initial verification, with potential supplementary materials and subsequent issuance of an acceptance number before technical review.

Key takeaways

• Gyre Pharmaceuticals Co., Ltd. submitted NDA on March 22, 2026
• NDA for F351 (Hydronidone)
• Indication: chronic hepatitis B (CHB)-induced liver fibrosis
• Submitted to Center for Drug Evaluation (CDE) of China’s National Medical Products Administration
• Subject to formatting and completeness verification
• Plans to submit supplementary materials if requested by CDE