Breakthrough! Hydronidone Reverses Liver Damage, Offering New Hope to Millions!
- Landmark Phase 3 trial shows Gyre Therapeutics' Hydronidone (F351) achieved statistically significant reversal of liver fibrosis in patients with chronic hepatitis B (CHB).
- A stunning 52.85% of patients treated with Hydronidone experienced at least a one-stage regression in liver fibrosis, nearly double the ~29.84% in the placebo group2, 5.
- This paves the way for Hydronidone to potentially become the first-ever approved therapy in China specifically targeting CHB-associated liver fibrosis.
In a groundbreaking development announced May 22, 2025, Gyre Therapeutics' lead compound, Hydronidone, has triumphed in its pivotal Phase 3 trial in China, offering a beacon of hope for millions battling chronic hepatitis B-related liver fibrosis2. For too long, patients have faced the grim progression towards cirrhosis, liver failure, and cancer with no approved anti-fibrotic treatments.
"These landmark Phase 3 results represent a major step forward," declared Han Ying, Ph.D., CEO of Gyre Therapeutics, underscoring the potential for Hydronidone to become the "first therapy specifically indicated for reversing liver fibrosis in CHB patients" in China2. Prof. Lungen Lu, the lead principal investigator, hailed the fibrosis regression as a "breakthrough," stating Hydronidone "has the potential to transform the treatment landscape and offer new hope"2.
The rigorous 52-week trial, involving 248 patients across China, demonstrated Hydronidone's remarkable efficacy and a strong safety profile, with results consistent with earlier promising data2, 7, 8. With approximately 75 million people in China chronically infected with hepatitis B, and an estimated 2.6 million diagnosed with advanced fibrosis, Hydronidone addresses an urgent, unmet medical need2.
Gyre now plans to seek regulatory approval in China and is eyeing expansion into the U.S. for MASH-related fibrosis, heralding a new era in the fight against liver disease2, 3.
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