Gyre Therapeutics receives NMPA priority review for Hydronidone (F351), an oral anti-fibrotic therapy for chronic hepatitis B-associated liver fibrosis in China.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
Gyre Therapeutics has received priority review designation from China’s Center for Drug Evaluation (CDE) for its investigational therapy Hydronidone (F351), marking a key regulatory step toward approval for chronic hepatitis B (CHB)-associated liver fibrosis.
The designation follows a pre-New Drug Application (NDA) communication with regulators earlier this year. The company, through its majority-owned subsidiary Gyre Pharmaceuticals, plans to submit the formal NDA in the near term. Priority review status is expected to accelerate the evaluation timeline, reflecting both the clinical urgency and the potential value of the therapy.
Hydronidone is a novel, orally administered anti-fibrotic agent designed to target central pathways involved in liver fibrosis. The drug works by modulating TGF-β1 signaling, reducing hepatic stellate cell activation and fibrogenesis. Mechanistically, it suppresses p38γ phosphorylation while increasing Smad7 expression, leading to downstream inhibition of the TGF-β/Smad pathway and reduced fibrotic gene expression.
The therapy has already completed Phase 3 clinical trials in China in patients with CHB-related liver fibrosis, including those with early compensated cirrhosis. Beyond hepatitis B-related disease, Hydronidone is also being explored for broader anti-fibrotic applications in other indications.
CHB-induced liver fibrosis remains a major global health burden. Persistent hepatitis B infection drives chronic inflammation, leading to progressive scarring of the liver and eventual cirrhosis or liver cancer. According to global estimates, more than 250 million people live with chronic hepatitis B worldwide, with a substantial proportion at risk of developing advanced liver disease. China represents one of the largest affected populations, underscoring the need for effective anti-fibrotic therapies.
If approved, Hydronidone could become a targeted treatment option addressing the underlying fibrotic process in CHB, an area where therapeutic options remain limited.
Reference
Gyre Therapeutics Announces China’s NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment, 17 March 2026, Gyre Therapeutics Announces China’s NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment | Gyre Therapeutics, Inc
About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.