Recently, the Chinese Expert Consensus on Antiviral Therapy for HBV Related Hepatocellular Carcinoma (2023 Edition) (hereinafter referred to as the Expert Consensus), co-developed by the Chinese Hepato-Pancreato-Biliary Chapter of the International Hepato-Pancreato-Biliary Association, the Chinese Society of Liver Cancer, and the Special Committee of Hepato-Pancreato-Biliary Surgery of the Chinese Research Hospital Association, was published in the Chinese Journal of Digestive Surgery, according to which Hansoh Pharma's Hengmu (tenofovir amibufenamide, TMF) is recommended for first-line treatment, reflecting the unanimous endorsement of the efficacy and safety of Hengmu by top hepatobiliary surgery and infectious liver disease experts in China.
Multiple studies have confirmed that antiviral therapy can significantly reduce fibrosis progression and liver cancer incidence in patients with chronic viral hepatitis B. For patients who have developed hepatitis B virus (HBV) associated liver cancer, aggressive and effective antiviral therapy can significantly improve patient prognosis. On this basis, the Expert Consensus further summarizes the latest clinical research evidence at home and abroad for different tumor stages and different anti-cancer regimens to help clinicians make rational decisions. Recommendation 4 states that first-line antiviral drugs, ETV, TDF, TAF or TMF, are recommended for patients with HBV-related hepatocellular carcinoma (strongly recommended, evidence level A).
The recommendation of Hengmu for first-line treatment this time was based on data from a large-scale Phase III clinical study. According to the study, compared with the existing first-line standard-of-care drug tenofovir disoproxil fumarate (TDF), TMF demonstrated a comparable virologic suppression rate and a higher ALT normalization rate. The complete virological suppression rate (serum HBV DNA < 20IU/mL) in the TMF group was comparable to that in the TDF group, specifically: 70.8% VS 72.0% in HBeAg(+) patients and 93.9% VS 93.3% in HBeAg(-) patients; and the ALT normalization rate in the TMF group was significantly better than that in the TDF group based on AASLD criteria.
In terms of safety, TMF showed superior bone and renal safety. The decrease in BMD from baseline was significantly lower in the TMF group than in the TDF group, with a mean decrease in hip BMD of -0.43 VS -2.45 and a mean decrease in spine BMD of 0.18 VS -1.98, and patients with long-term medication had less BMD loss; and the decrease in eGFR from baseline was significantly lower in the TMF group than in the TDF group, showing better renal safety.
In November 2022, the data from the large-scale Phase III clinical study of Hengmu was published in the Journal of Clinical and Translational Hepatology (JCTH), an internationally renowned academic journal of hepatology, and received high recognition from the international academic community of hepatology. As the first Chinese original oral anti-hepatitis B innovative drug independently developed by Hansoh Pharma, Hengmu offers a better treatment option to clinicians, and has benefited more than 100,000 Chinese patients with chronic hepatitis B since its launch.
Looking ahead, Hansoh Pharma will continue to increase investment in R&D and strengthen efforts in the prevention and treatment of chronic viral hepatitis towards the ambitious goal of "Healthy China 2030".