GYRE THERAPEUTICS, INC. 8-K

What Happened
Gyre Therapeutics, Inc. announced on January 5, 2026 that its majority‑owned China subsidiary, Gyre Pharmaceuticals Co., Ltd., completed a Pre‑New Drug Application (Pre‑NDA) communication meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) regarding Hydronidone, the company’s first‑in‑class anti‑fibrotic candidate. The company furnished a press release about the meeting as Exhibit 99.1 to the Form 8‑K.

Key Details

• Date filed: January 5, 2026 (Form 8‑K, Item 7.01).
• Party: Gyre Pharmaceuticals Co., Ltd. is a majority‑owned subsidiary of Gyre Therapeutics.
• Topic: Pre‑NDA communication meeting with the CDE of China’s NMPA concerning Hydronidone.
• Disclosure: Press release furnished as Exhibit 99.1 to the Form 8‑K.

Why It Matters
A Pre‑NDA meeting with the CDE is a formal regulatory step before submitting a New Drug Application in China and indicates active progress in Hydronidone’s regulatory pathway there. For investors, this is a material development in the company’s clinical/regulatory progress—monitor future updates for any NDA filing, regulatory guidance received, or timelines shared by the company.