Gyre Therapeutics (GYRE) said Monday its Chinese unit reached an agreement with China's Center for Drug Evaluation to seek conditional approval for its liver fibrosis treatment Hydronidone.

The CDE determined that current phase 3 clinical data support the submission of an application for chronic hepatitis B-associated liver fibrosis, the company said.

The company also said it intends to file the formal marketing application during H1 of 2026.

It will also perform a confirmatory clinical study to track long-term health outcomes and support a transition to full regulatory approval, Gyre said.

Shares of the company were up by over 2% in recent Monday premarket activity.