Gyre Therapeutics announced that China’s NMPA has accepted the NDA for F351 (hydronidone) for chronic hepatitis B-associated liver fibrosis following priority review designation, advancing the anti-fibrotic therapy toward potential approval in China.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
Gyre Therapeutics announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) for the treatment of chronic hepatitis B (CHB)-induced liver fibrosis.
The NDA was submitted through the company’s majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd., following the grant of priority review designation by the NMPA in March 2026. The acceptance marks a key regulatory milestone for Gyre as it advances F351 toward potential commercialization in China.
F351 is a structurally modified derivative of Pirfenidone designed to improve metabolic properties while targeting the TGF-β1 signaling pathway, a central driver of fibrogenesis. The therapy is being developed for CHB-associated liver fibrosis in China and for MASH-associated liver fibrosis in the United States.
In the U.S., Gyre has completed a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of F351 in healthy volunteers and plans to submit an Investigational New Drug (IND) application by the end of 2026 to support a planned Phase 2 trial.
Dr. Ying Luo, President and Chief Executive Officer of Gyre, said the company’s discussions with the CDE have been encouraging and reflect regulatory recognition of the unmet need in liver fibrosis treatment. She noted that F351 has the potential to address a large population of patients in China living with HBV infection who are at risk of developing fibrosis and cirrhosis.
Liver fibrosis develops when chronic inflammation causes progressive scarring of liver tissue and can eventually progress to cirrhosis, liver failure, and hepatocellular carcinoma (HCC).
According to the company, viral hepatitis accounts for up to 50% of fibrosis cases and approximately 65% of cirrhosis cases worldwide. Gyre also noted that no non-antiviral therapy has yet demonstrated fibrosis reduction in viral hepatitis-associated liver disease.
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About the Writer
Mahathi Palivela (LinkedIn) is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication