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

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

Trial completion • Fibrosis • Immunology • Liver Cirrhosis

A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis (clinicaltrials.gov) - P2 | N=411 | Completed | Sponsor: Beijing Continent Pharmaceutical Co, Ltd. | Recruiting ➔ Completed | N=200 ➔ 411

Enrollment change • Trial completion • 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=337 | Completed | Sponsor: Beijing Continent Pharmaceutical Co, Ltd. | Recruiting ➔ Completed | Trial completion date: Oct 2026 ➔ Jul 2026 | Trial primary completion date: Oct 2026 ➔ Jul 2026

Trial completion • Trial completion date • Trial primary completion date • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • 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=67 | Completed | Sponsor: Beijing Continent Pharmaceutical Co, Ltd. | N=150 ➔ 67 | Recruiting ➔ Completed

Enrollment change • Trial completion • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Beijing Continent Pharmaceutical Co, Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Oct 2026 ➔ May 2026

Trial completion • Trial completion date • Fibrosis • Hepatology • Immunology • 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. | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

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

Trial completion • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Application of Multilineage Human Liver Organoids in Disease Modelling, Drug Testing and Genetic Intervention. (PubMed, Liver Int) - "Multilineage hLOs provide a human-relevant platform for modelling fibrosis and MASLD and for evaluating therapeutic and genetic interventions in a multicellular liver context."

Journal • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • STAT3 • TGFB1

Exploring Mitochondrial Genetic Features in Intervertebral Disc Degeneration through Multi-Omics Integration Analyses. (PubMed, J Gerontol A Biol Sci Med Sci) - "Furthermore, 15 drugs targeting GATM were identified, with HYDRONIDONE completing molecular docking. Through the integration of multi-omics data, we identified 5 promising therapeutic targets for IVDD, with GATM exhibiting the most consistent multi-omics signal, and discovered 15 drugs targeting GATM and 11 drugs targeting ACADS."

Journal • ATP23

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

Enrollment open • Fibrosis • Hepatitis B • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

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

Enrollment open • Fibrosis • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

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

Trial completion • Fibrosis • Hepatology • Immunology

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

Enrollment open • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

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