Hansoh Pharma's Novel Oral Anti-HBV Drug Tenofovir Amibufenamide (TMF) Phase 3 144-Week Data Selected as Late-Breaking Abstract at AASLD 2023

Amibufenovir isA Novel Nucleoside Reverse Transcriptase InhibitorIt utilizes the innovative ProTide (phosphoramidate prodrug) technology to achieve targeted delivery of tenofovir (TFV) into hepatocytes. While increasing the concentration of the active metabolite TFV-DP within liver cells, it significantly reduces the plasma exposure of TFV, thereby efficiently inhibiting HBV replication while lowering the safety risks associated with long-term use.Hansoh Pharma's Amytinofovir Tablets Approved for Marketing in China in June 2021 for the Treatment of Chronic Hepatitis B in Adults。

This is a randomized, double-blind, non-inferiority clinical trial presented at the AASLD annual meeting, conducted across 49 research centers in China with a total of 1,005 patients with chronic hepatitis B enrolled to evaluate the efficacy and safety of Aimitinovir (TMF) compared to Tenofovir Disoproxil Fumarate (TDF) over 144 weeks.

The research results show that, compared with TDF,Regardless of baseline viral load levels(≥8 log10 IU/mL and <8 log10 IU/mL), TMF group and TDF group(Defined as receiving TDF treatment from 0 to 96 weeks, then switching to TMF after 96 weeks)Virological Response Rate（HBV DNA<20 IU/mL）And Alanine Aminotransferase（ALT）The recovery rate is quite similar.; In the TMF group and TDF group, whether patients had sustained viral response before 96 weeks, low-level viremia, or no virological response,Virological response and ALT normalization rate at Week 144 were improved after taking TMF from Week 96 to Week 144.。

In terms of safety, TMF demonstrated superior bone and renal safety. After switching from TDF to TMF treatment for 48 weeks, up to 96 weeks, bone mineral density in the hip, femoral neck, and lumbar spine of patients with sustained virological response, low-level viremia, or no virological response increased by 0.8%, 0.6%, and 0.7%, respectively, and the mean glomerular filtration rate increased by 2.3 ml/min.

Previously, the 48-week data from the Phase 3 clinical study of Aimitinovir had already been published inAliment Pharmacol Therapeutics，96-Week DataPublished inJournal of Clinical and Translational Hepatology, previous data have all demonstrated the product's good anti-hepatitis B virus efficacy and superior bone and renal safety. In February 2023, the Hepatology Society and Infectious Diseases Society of the Chinese Medical Association jointly released the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)".AmtenofibRecommended as the first-choice antiviral treatment for chronic hepatitis B due to its good efficacy and safety.