GYRE THERAPEUTICS, INC. 8-K

What Happened Gyre Therapeutics, Inc. announced on May 12, 2026 (via an 8‑K Regulation FD disclosure) that Gyre Pharmaceuticals Co., Ltd., its majority indirectly owned subsidiary, received notification that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for F351 (Hydronidone). F351 is the company’s lead product candidate, submitted for the treatment of chronic hepatitis B‑induced liver fibrosis. The company furnished a press release reporting this development as Exhibit 99.1 to the 8‑K.

Key Details

• Date of disclosure: May 12, 2026.
• Applicant: Gyre Pharmaceuticals Co., Ltd. (majority indirectly owned by Gyre Therapeutics).
• Regulatory action: NMPA (Center for Drug Evaluation) accepted the New Drug Application (NDA).
• Product & indication: F351 (Hydronidone) for chronic hepatitis B‑induced liver fibrosis.

Why It Matters Acceptance of an NDA by China’s NMPA is a formal regulatory milestone that opens the official review process and is a necessary step toward potential approval and commercialization in China. For investors, this advances Gyre’s lead asset through a key regulatory gate in a large market for hepatitis B therapies; subsequent updates (review timeline, approval decision, or additional regulatory requests) will be material. This 8‑K is a disclosure of that milestone—investors should watch for further filings and company updates on review progress and any regulatory communications.