Hansoh Pharma's Hengmu (Tenofovir Amibufenamide) Showcases Over 20 Research Outcomes at APASL 2025, Reinforcing Long-Term Efficacy and Safety Profile

Recently, the highly anticipated 34th Asia-Pacific Association for the Study of the Liver Annual Meeting (APASL 2025) was held in Beijing. At this conference, more than 20 academic achievements of Hengmu (Amitinofivir, TMF), China's first domestically developed oral anti-hepatitis B virus drug independently researched by Hansoh Pharma, were released. Among them, two research achievements were selected for oral presentation, namely the 5-year follow-up results of Hengmu Phase IV study and the research results on the immunological mechanism of antiviral treatment.

The 5-year follow-up results of the Phase IV study showed that Hengmu (Hansoh Pharma's product) treatment for patients with chronic hepatitis B continued to provide benefits across multiple efficacy endpoints, particularly in virological response and HBeAg seroclearance. The cumulative HBV DNA suppression rate at 5 years was as high as 95%, and the HBeAg seroclearance rate reached 68%, the highest among current NA-class drugs. Hengmu treatment made 63% of patients a functionally cured advantageous population, with a cumulative virological resistance rate of 0% over 5 years. In terms of safety, no new drug-related adverse events were found during the study period, and bone, renal, and lipid safety parameters remained stable.

Research Results on the Immunological Mechanism of Antiviral Therapy Show That Hansoh Pharma’s Hengmu Exhibits Significant Antiviral Activity and Immunomodulatory Effects in Both Chronic HBV Infection and HBV Replication Mouse Models. It May Treat Chronic HBV Infection by Modulating T-Cell Responses and Reducing Viral Load, Thereby Revealing the Potential Molecular Immunological Mechanism Behind Hengmu’s Significant Antiviral Efficacy (High HBeAg Seroclearance Rate).

More than 20 other Hengmu-related studies were presented in the form of posters or electronic posters (ePosters). The content covers the application of Hengmu in various subgroups of chronic hepatitis B, including the elderly, pregnant women, cirrhosis, liver failure, end-stage liver disease, liver cancer, and comorbid hyperlipidemia. These studies evaluated the impact of Hengmu on blood glucose and lipid levels, as well as its clinical applications in combination with interferon or other drugs. Among these, a systematic review and network meta-analysis showed that among four new-generation NA drugs [TAF, TMF, BSV, and PDV], Hengmu demonstrated superior advantages in normalizing ALT and delaying the progression of liver fibrosis, with the best safety profile for bones and kidneys. A retrospective study provided the first evidence that Hengmu treatment in pregnant women with chronic hepatitis B ensures favorable maternal and infant safety and efficacy. Combined with standard hepatitis B immunization, it can successfully prevent HBV mother-to-child transmission. Another retrospective real-world study confirmed for the first time that Hengmu treatment in patients with HBV-related hepatocellular carcinoma (HCC) is effective and safe, showing a higher rate of ALT normalization and better lipid profiles compared to ETV. Two studies on patients with HBV-related acute-on-chronic liver failure (HBV-ACLF) indicated that the efficacy of Hengmu is comparable to that of ETV and TAF. Multiple studies have shown that Hengmu does not affect glucose and lipid metabolism in patients.

These studies have confirmed from different perspectives that Henmu has significant antiviral efficacy and safety advantages, also provided evidence-based references for the clinical optimization of treatment in patients with chronic hepatitis B (CHB).