neracorvir (GST-HG141) / Fujian Cosunter - LARVOL DELTA

A randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial of GST-HG141 as add-on therapy for patients with chronic hepatitis B (CHB) who have an inadequate response to antiviral drug treatment (ChiCTR) - P3 | N=526 | Not yet recruiting | Sponsor: Shulan (Hangzhou) Hospital; Shulan (Hangzhou) Hospital

New P3 trial • Hepatitis B • Infectious Disease • Inflammation

To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment (clinicaltrials.gov) - P3 | N=526 | Recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Infectious Disease • Inflammation

To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment (clinicaltrials.gov) - P3 | N=526 | Not yet recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

New P3 trial • Hepatitis B • Infectious Disease • Inflammation

Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets (clinicaltrials.gov) - P2 | N=90 | Completed | Sponsor: Fujian Akeylink Biotechnology Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: Aug 2023 ➔ Jul 2024

Trial completion • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety, pharmacokinetics, and antiviral efficacy of the novel capsid assembly modulator GST-HG141 in patients with chronic hepatitis B: a phase 1 trial with a randomized, placebo-controlled design. (PubMed, Virol J) - "These concentrations adequately covered the protein binding-adjusted EC50 (16.89 ng/mL) by factors of 4.4, 11.1, and 14.6 for doses of 25, 50, and 100 mg, respectively. Our study demonstrated GST-HG141's well-tolerated profile up to 100 mg over 4 weeks, alongside robust antiviral activity in CHB patients, supporting its progression into further clinical investigation for CHB management."

Clinical • Journal • P1 data • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety, pharmacokinetics and antiviral activity of GST-HG141, a hepatitis B virus capsid assembly modulator, in subjects with chronic hepatitis B (EASL-ILC 2022) - P1 | "Oral BID dosing with 25, 50 or 100 mg of GST-HG141 for 28 days was safe and well tolerated. It resulted in rapid, robust and dose-dependent decline in serum HBV DNA. Serum HBV pgRNA levels also decreased significantly."

Clinical • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

GST-HG141 inhibits de novo HBV cccDNA formation in cultured primary human hepatocytes (EASL-ILC 2022) - "Treatment with GST-HG141, GLS4, or Entecavir (ETV) started concurrently with infection, or 5 days postinfection. These data demonstrate that GST-HG141 prevents de novo synthesis of cccDNA, but has no effect on the established cccDNA pools in cultured PHH. It acts on different steps of the HBV life cycle, suggesting dual/multiple mechanisms of antiviral action. Further development of GST-HG141 for chronic HBV infections is warranted."

Hepatitis B • Infectious Disease

Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd | Not yet recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Guangshengtang (300436.SZ) identified Niu Junqi as the Phase II study leader of the innovative hepatitis B drug GST-HG141 project [Google translation] (Sina Corp) - "Guangshengtang...announced that the company recently confirmed that Professor Niu Junqi...will be appointed as GST-HG141 clinical phase II...The company will push the project into phase II clinical phase as soon as possible."

Clinical • Hepatitis B • Infectious Disease

Guangshengtang: The company's hepatitis B core protein inhibitor GST-HG141 is currently in phase Ib clinical trials as planned [Google translation] (Daily Economic News - NBD) - "This month, the first patient enrolled in GST-HG141 will complete the evaluation of the primary and secondary endpoint indicators. It is hoped that the five-year innovative drug will have a preliminary result, and I hope to announce the endpoint evaluation of the first patient in the group in time...The company will actively promote the clinical trials of the project."

Clinical • Hepatitis B • Infectious Disease

Guangshengtang (300436.SZ): The first patient in the phase Ib clinical trial of the innovative hepatitis B treatment drug GST-HG141 was successfully enrolled [Google translation] (Sina Corp) - "Guangshengtang...issued an announcement that the company's phase Ib clinical trial of the company's innovative hepatitis B treatment drug GST-HG141 has recently obtained the administrative license of the 'China Human Genetic Resources International Cooperative Scientific Research Approval', and the first patient will be in July 2021. On the 23rd, he was successfully enrolled in the first hospital of Jilin University for administration."

Trial status • Hepatitis B • Infectious Disease

Safety, tolerability, and pharmacokinetics of the novel hepatitis B virus capsid assembly modulator GST-HG141 in healthy Chinese subjects: a first-in-human single- and multiple-dose escalation trial. (PubMed, Antimicrob Agents Chemother) - " GST-HG141 was tolerated in healthy Chinese subjects. The safety and PK profiles of GST-HG141 support the further evaluation of its efficacy in individuals with CHB."

Clinical • Journal • P1 data • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Guangshengtang: The clinical research summary report of a phase Ia clinical trial of an innovative hepatitis B treatment drug [Google translation] (Eastmoney.com) - P1a, N=104; NCT04386915; Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd; "Guangshengtang...announced...that the company's innovative hepatitis B treatment drug GST-HG141 has completed the phase Ia clinical trial...The study results showed that each study dose group of GST-HG141 tablets was tolerable and safe in Chinese healthy subjects. Good, the plasma concentration reached the expected target. GST-HG141 tablets are used for the treatment of chronic hepatitis B; the company is actively promoting the development of phase Ib clinical trials of the drug."

P1 data • Hepatitis B • Infectious Disease

[VIRTUAL] GST-HG141, a novel clinical-stage hepatitis B virus capsid assembly modulator (EASL-ILC 2021) - "Combination with Tenofovir resulted in additivity. GST-HG141 is a novel, orally-bioavailable HBV CAM. It accelerates HBV capsid assembly in vitro, leading to formation of “empty” capsids, devoided of genetic material. However, its mode of action and resistance profile appear to be distinct from other class I CAMs in development."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Guangshengtang: At present, the hepatitis B core protein inhibitor GST-HG141 has completed phase Ia clinical trials with good overall safety. It is actively promoting clinical trials for phase Ib patients and has obtained approval from the ethics committee for phase Ib clinical trials of the First Hospital of Jilin University [Google translation] (Daily Economic News - NBD) - P1, N=104; NCT04386915; Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd; "Guangshengtang...stated on the investor interaction platform...present, the hepatitis B core protein inhibitor GST-HG141 has completed phase Ia clinical trials with good overall safety and is actively promoting Ib Phase I clinical trials of drugs for patients have been approved by the ethics committee of the Phase Ib clinical trial of the First Hospital of Jilin University; the hepatitis B surface antigen inhibitor GST-HG131 is in phase Ia clinical trials and is progressing smoothly."

P1 data • Hepatitis B • Infectious Disease

Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd

Clinical • New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Guangshengtang (300436.SZ) obtains patent certificate or authorization notice for some innovative drugs under research [Google translation] (Sina Corp) - "Guangshengtang...has obtained a patent certificate or authorization notice for an innovative drug under development. The details are as follows:...Innovative hepatitis B treatment drug GST-HG141 obtained Eurasian patent authorization notice, hepatitis B treatment innovative drugs GST-HG131, GST-HG121 obtained U.S. and Taiwan patent certificates or authorization notices..."

Patent • Hepatitis B • Infectious Disease

Guangshengtang (300436.SZ) hepatitis B innovative drug GST-HG141 was approved by the ethics committee for phase Ib clinical trials [Google translation] (Sina Corp) - P1a, N=NA; "Guangshengtang...announced that the company recently obtained the review opinion on the phase clinical trial and research of the innovative hepatitis B treatment drug GST-HG141 Ib issued by the Ethics Committee of the First Hospital of Jilin University. This indicates that the Phase Ib clinical trial program has been reviewed and determined, and the trial has been approved...The animal in vivo efficacy test showed an excellent virus Inhibition. The completed Phase Ia clinical trial shows good overall safety and is one of the important components of the company's hepatitis B clinical cure 'climbing plan'."

New P1 trial • P1 data • Preclinical • Hepatitis B • Infectious Disease

[VIRTUAL] In Vitro and In Vivo Antiviral Properties of GST-HG141, a Novel Hepatitis B Virus Capsid Assembly Modulator in Clinical Development (APASL 2021) - No abstract available

Hepatitis B • Hepatology • Infectious Disease

Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets (clinicaltrials.gov) - P1; N=104; Recruiting; Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatitis B • Infectious Disease

Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets (clinicaltrials.gov) - P1; N=104; Not yet recruiting; Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd

Clinical • New P1 trial • Hepatitis B • Infectious Disease