GYRE THERAPEUTICS, INC. 8-K

What Happened Gyre Therapeutics, Inc. (GYRE) reported on Form 8-K that on March 22, 2026 its majority indirectly owned subsidiary, Gyre Pharmaceuticals Co., Ltd., submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration for F351 (Hydronidone). The submission is for Hydronidone to treat chronic hepatitis B (CHB)‑induced liver fibrosis. The CDE will first perform formatting and completeness checks and is expected to issue an acceptance number before starting a technical review.

Key Details

• Filing date: March 22, 2026 (NDA submission by subsidiary).
• Product: F351 (Hydronidone) for treatment of CHB‑induced liver fibrosis.
• Regulator: Center for Drug Evaluation (CDE) of China’s National Medical Products Administration.
• Next steps: NDA subject to initial formatting/ completeness verification; CDE may request supplementary materials and will issue an acceptance number prior to technical review.

Why It Matters An NDA submission is a major regulatory milestone toward potential marketing approval in China, a large market for hepatitis B treatments. For investors, this advances Gyre’s lead product candidate from clinical development toward regulatory review, but it is not an approval—additional information may be requested and the CDE must accept and complete its technical review before any approval decision. The company’s 8‑K also includes standard forward‑looking statement cautions and refers investors to its SEC filings for risk factors.