hydronidone (F351) / GNI Group, Gyre Therapeutics - LARVOL DELTA

Gyre Therapeutics Announces China’s NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment (GlobeNewswire) - "This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process."

China filing • Priority review • Fibrosis • Hepatitis B

[¹⁴C] Hydronidone Mass Balance Study (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P1 trial • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P2 trial • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B. (clinicaltrials.gov) - P3 | N=1208 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P3 trial • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Pharmacokinetics of Hydroxynidone Capsules in Subjects With Hepatic Impairment and Matched Healthy Controls: A Phase I Study (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P1 trial • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

Hydronidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia (clinicaltrials.gov) - P2/3 | N=298 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P2/3 trial • Infectious Disease • Pneumonia • Respiratory Diseases

A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P2 trial • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P3 trial • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

Gyre Therapeutics Announces Alignment with China’s CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting (The Manila Times) - "During the meeting, Gyre Pharmaceuticals and the CDE reached consensus that existing Phase 3 clinical data for Hydronidone, based on histologic improvement in liver fibrosis as measured by the Ishak fibrosis score, are generally supportive of submission of a conditional approval NDA for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis, including early (compensated) cirrhosis. The CDE further indicated that Hydronidone meets the criteria for inclusion in China’s Priority Review and Approval Program for Innovative Drugs, subject to formal filing, acceptance and regulatory review...The Company currently expects to submit an NDA for conditional approval of Hydronidone in the first half of 2026..."

China filing • Non-US regulatory • Fibrosis • Hepatitis B

Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P1 trial • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

The Phase Ⅰd Clinical Trial of Hydronidone Capsules (clinicaltrials.gov) - P1 | N=138 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P1 trial • Fibrosis • Immunology • Liver Cirrhosis

A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease

QTc Assessment in a Single-Dose Study of Hydronidone Capsules (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

New P1 trial • Fibrosis • Hepatology • Immunology

Hydronidone Mitigates Pulmonary Fibrosis by Regulating the TGF-β/Smad2/3 Axis in in Vitro and in Vivo Models. (PubMed, ACS Pharmacol Transl Sci) - "Although antifibrotic drugs like nintedanib and pirfenidone can slow disease progression, their clinical benefits remain modest...In an in vivo manner, a bleomycin (BLM)-induced PF mouse model was employed...Hydronidone effectively reduces pulmonary fibrotic marker expression and improves lung function at lower doses (25 and 50 mg/kg) than pirfenidone (100 mg/kg) without compromising the safety profile. These findings support its potential as a promising antifibrotic agent and warrant further clinical investigation."

Journal • Preclinical • Fibrosis • Immunology • Liver Cirrhosis • Pulmonary Disease • Respiratory Diseases • SMAD2 • SMAD4 • TGFB1

Pipeline Development Updates: Hydronidone (GlobeNewswire) - "The Company remains on track to advance regulatory filing activities and intends to proceed with the NDA submission for Hydronidone in China upon completion of ongoing regulatory interactions and resolution of any outstanding requirements. The anticipated timeline for submitting the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis has been adjusted due to the delayed availability of the full Phase 3 trial data set from the completed trial of Hydronidone for the treatment of CHB-associated liver fibrosis in China....With these activities underway, Gyre expects to file the U.S. IND for Hydronidone for the treatment of MASH-associated liver fibrosis in 2026, and, subject to U.S. IND clearance, initiate a Phase 2 trial."

China filing • IND • Metabolic Dysfunction-Associated Steatotic Liver Disease

HYDRONIDONE ACTIVATES THE PTEN–ATG7 AXIS TO RESTORE MITOPHAGY AND CURB OXIDATIVE STRESS IN HEPATOCYTES DURING EXPERIMENTAL LIVER FIBROSIS (AASLD 2025) - "HDD mitigates hepatocyte injury in fibrotic liver by binding to PTEN and activating the PTEN–ATG7 pathway, which restores mitophagy and limits oxidative stress. These findings position HDD as a promising therapeutic candidate for liver fibrosis."

Oxidative stress • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • ATG7 • PTEN

THE MECHANISM OF HYDROXYNIDONE IN THE TREATMENT OF LIVER FIBROSIS BY TARGETING CTSL-SIRT1 TO REGULATE LIPID METABOLISM REPROGRAMMING OF HEPATIC STELLATE CELLS. (AASLD 2025) - "By targeting the CTSL enzyme active site in HSC, hydronidone inhibits the degradation of SirT1 by CTSL, thereby protecting the intrinsic endogenous lipid droplets of HSC and inhibiting HSC activation, thereby reversing liver fibrosis."

Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • CTSL • SIRT1 • TGFB1

FROM TRIALS TO TARGETS: HYDRONIDONE'S MECHANISTIC ROLE IN REVERSING HEPATIC FIBROSIS (AASLD 2025) - "HDD reversed the glycolytic reprogramming mediated by LOXL2/YBX1/HIF1a axis during HSC activation. HDD alleviated liver fibrosis by directly targeting STAT3 which regulated Loxl2 at transcriptional level in HSCs."

Fibrosis • Hepatology • Immunology • Liver Cirrhosis • HIF1A • JAK1 • STAT3 • YBX1

PHASE 3 TRIAL OF HYDRONIDONE FOR LIVER FIBROSIS IN CHRONIC HEPATITIS B (AASLD 2025) - P3 | "Despite antiviral therapy with entecavir, 25.81% of placebo-treated patients experienced fibrosis progression, compared to only 8.94% in the hydronidone group... Hydronidone was superior to placebo in promoting fibrosis regression and demonstrated a favorable safety profile in CHB patients. (NCT05115942)"

P3 data • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • TGFB1

Hydronidone Alleviates Metabolic Dysfunction-Associated Fatty Liver Disease by Inhibiting CD36 Expression. (PubMed, FASEB J) - "Overexpression of CD36 blocked the therapeutic effect of HDD on MASLD models. HDD could alleviate the disease progression by inhibiting the expression of CD36 in MASLD mice and cell models."

Journal • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • CD36 • SCARB1

TGF-β inhibitors: the future for prevention and treatment of liver fibrosis? (PubMed, Front Immunol) - "In clinical trials, drugs such as Pirfenidone and Hydronidone have demonstrated potential for fibrosis reversal in patients with chronic hepatitis. Although TGF-β-targeted therapy has made breakthroughs in basic research and clinical translation, future studies need to focus on multi-target drug design, personalized treatment regimens, and novel delivery systems to accelerate the transition from preclinical research to clinical application, providing innovative therapeutic strategies for liver fibrosis and related liver diseases."

Journal • Review • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Oncology • Solid Tumor • SMAD4 • TGFB1

Mechanism-guided drug development and treatment for liver fibrosis: a clinical perspective. (PubMed, Front Pharmacol) - "Moreover, multi-pathway guided combination therapy or traditional Chinese medicine demonstrate significant advantages in combating liver fibrosis. Finally, new technologies and approaches affecting the clinical development of anti-hepatic fibrosis drugs were discussed."

Journal • Review • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Oncology • Solid Tumor • FASN • FGF21

Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial. (PubMed, J Clin Transl Hepatol) - "Our Phase 2 trial of hydronidone for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis showed that adding hydronidone to entecavir resulted in significant reversal of liver fibrosis...The primary endpoint of the trial is to demonstrate the efficacy of fibrosis reversal, defined as a decrease in the Ishak stage score of liver fibrosis by ≥1 after 52 weeks of treatment, compared to baseline. The results of this trial are expected to further support the antifibrotic indication for this novel drug."

Journal • P3 data • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Gyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Pipeline Development Updates: F351 (Hydronidone): (i) All patients completed 52-week pivotal Phase 3 trial in chronic hepatitis B ('CHB')-associated liver fibrosis in the PRC. In October 2024, Gyre Pharmaceuticals announced the last patient completed the 52-week pivotal Phase 3 trial. The trial is evaluating 248 patients with CHB-associated liver fibrosis in the PRC with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one stage after taking F351 in combination with entecavir. Gyre expects to report topline data in the second quarter of 2025; (ii) Plans to initiate a Phase 2 clinical trial in metabolic dysfunction-associated steatohepatitis ('MASH')-associated liver fibrosis in 2025. Pending the results from the pivotal Phase 3 trial in CHB-associated liver fibrosis, Gyre intends to initiate a Phase 2 proof-of-concept trial in the U.S. to evaluate F351 for the treatment of MASH-associated liver fibrosis in 2025."

Enrollment closed • New P2 trial • P3 data: top line • Fibrosis • Metabolic Dysfunction-Associated Steatotic Liver Disease