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Gyre Therapeutics Says China Regulator Accepts Application for Liver Fibrosis Drug

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Gyre Therapeutics Inc (GYRE) said China's regulator accepted its new drug application for F351, a treatment for chronic hepatitis B-induced liver fibrosis.

The application, which received priority review status in March, marks "a significant milestone" in the program's path toward commercialization, the company said Tuesday in a statement.

In the US, Gyre has completed a Phase 1 trial evaluating the drug's safety and tolerability in healthy volunteers and plans to file an investigational new drug application by the end of 2026, with a Phase 2 trial to follow if cleared.

Gyre shares rose 1.4% in after-hours trading.

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