The Phase III clinical trial of Hengmu (Tenofovir Amibufenamide Tablets) was a randomized, double-blind, non-inferiority clinical trial, which enrolled 1,005 patients with chronic hepatitis B (CHB) and was carried out in 49 research centers to study the efficacy and safety of tenofovir amibufenamide (TMF) versus tenofovir disoproxil fumarate (TDF) over 96 weeks. The results of the clinical trial reaffirmed the significant efficacy and superior safety of TMF in the long-term treatment of patients with CHB.
Compared with the existing first-line standard-of-care drug 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 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. As a new second-generation tenofovir, TMF enables the targeted delivery of TFV to hepatocytes through the innovative ProTide (phosphoramidate prodrug) technology, which increases the concentration of the active metabolite TFV-DP in hepatocytes while significantly reducing the exposure of TFV in plasma, thus effectively inhibiting HBV replication and reducing the safety risk of long-term use. Clinical data prove that TMF has shown superior bone and kidney safety while ensuring good anti-HBV efficacy, and will be an excellent choice for long-term medication for adult patients with CHB. Hengmu (Tenofovir Amibufenamide Tablets) is the first innovative oral anti-HBV drug independently developed by Hansoh Pharma in China, and has successfully benefited more than 100,000 Chinese patients with CHB since its launch more than one year ago, providing clinicians with a better treatment option. "The publication of data from the Phase III clinical trial of Hengmu in JCTH reflects the high recognition of Hengmu by the international academic community of hepatology. Hansoh Pharma will keep investing more in clinical trials to help improve the health of the whole population and contribute to the Healthy China 2030 goal." Lyu Aifeng, Executive Director of Hansoh Pharma Group, remarked. About JCTHThe Journal of Clinical and Translational Hepatology (JCTH, pISSN:2225-0719, eISSN:2310-8819) is an English academic journal focusing on liver disease, sponsored by the Second Affiliated Hospital of Chongqing Medical University and published by XIA & HE Publishing Inc. (XHP). JCTH was founded in July 2013 and has published more than 600 papers in total. The journal has received its latest impact factor of 5.065 in 2021, ranking 36th among 93 SCI-indexed gastroenterology and hepatology journals worldwide, in category Q2. About Hansoh PharmaFounded in 1995, Hansoh Pharmaceutical Group Company Limited, the main business entity of Hansoh Pharma, is a leading innovation-driven pharmaceutical company in China. Adhering to the corporate mission to create excellence in pharmaceuticals and enhance innovation in China, Hansoh Pharma focuses on the treatment of oncology, infection, CNS, metabolism and autoimmunity diseases, and is committed to improving human health through continuous innovation. Up to now, Hansoh Pharma has marketed six innovative drugs and formed a rich pipeline, ranked among the top 30 of China's Top 100 Companies in Pharmaceutical Industry and the top 3 of China's Best Industrial Enterprises in Pharmaceutical R&D Pipeline for consecutive years. It is a national key high-tech enterprise and national technology innovation demonstration enterprise. Hansoh Pharma went public on the Stock Exchange of Hong Kong Ltd. in June 2019 (SEHK: 3692).
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