GYRE THERAPEUTICS (GYRE) Company Report

Gyre Therapeutics' majority-owned subsidiary, Gyre Pharmaceuticals, has achieved alignment with China's CDE for a conditional approval pathway and priority review eligibility for its anti-fibrotic therapy, Hydronidone.
The company plans to submit a New Drug Application (NDA) for conditional approval of Hydronidone in the first half of 2026.
This regulatory progress is supported by positive Phase 3 clinical data, which showed 52.85% of treated patients achieved ≥1-stage fibrosis regression at Week 52, meeting the primary endpoint.
Hydronidone addresses a significant unmet medical need in China for CHB-associated liver fibrosis, with an estimated 2.6 million patients potentially eligible for anti-fibrotic intervention.

Jan 5, 2026, 12:06 PM

Gyre Therapeutics Reports Q3 2025 Financial Results and Revises Full-Year Guidance

GYRE

Earnings

Guidance Update

Product Launch

Gyre Therapeutics reported Q3 2025 revenue of $30.6 million, a 20% increase year-over-year, and net income of $5.9 million, doubling from the prior year period, with basic EPS of $0.04.
For the nine months ended September 30, 2025, revenue was $79.4 million and net income was $11.2 million, resulting in basic EPS of $0.08.
The company revised its full-year 2025 revenue guidance to $115-118 million from the previous $118-128 million, primarily due to slower-than-expected commercialization of Etorel® and market uncertainty in China.
As of September 30, 2025, Gyre Therapeutics held $80.3 million in cash, cash equivalents, and short and long-term deposits.
Key pipeline updates include the Hydronidone New Drug Application (NDA) progressing in China and an adjusted U.S. IND timeline for Hydronidone for MASH-associated liver fibrosis to 2026.

Nov 7, 2025, 2:55 AM

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GYRE THERAPEUTICS (GYRE)