On July 23,2022, the anniversary celebration for the launch of and the academic conference on Hansoh Pharma's Hengmu (Tenofovir Amibufenamide Tablets), with a theme of Perseverance Makes Excellence, Care Creates New Life, were successfully held. The event was jointly staged in six cities: Nanjing, Shanghai, Guangzhou, Chongqing, Jinan and Hefei. More than 400 elites and clinical experts in the field of viral hepatitis treatment across China attended the event, at which they shared the relevant research on clinical cure of chronic hepatitis B (CHB), discussed the hot and difficult issues of clinical cure, and made the strongest voice in CHB treatment.
Chinese original research to promote clinical progress
According to statistics, there are about 70 million of hepatitis B virus carriers in China, including about 20-30 million cases of CHB, ranking first in the world. Hepatitis B is still one of the most serious public health problems facing China. For a long time, there has been an urgent clinical need for anti-HBV drugs with high efficacy, high drug resistance barrier and low bone and kidney safety risks, especially for nucleoside (acid) analogues (NAs).
Through the innovative ProTide (phosphoramidate prodrug) technology, Hengmu (Tenofovir Amibufenamide Tablets) enables the targeted delivery of TFV to hepatocytes, 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 Tenofovir Amibufenamide Tablets have 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.
At the event, the Chairman fully affirmed that Hengmu (Tenofovir Amibufenamide Tablets), as the first original oral anti-HBV drug in China, has brought significant pharmaceutical improvement to the clinical cure of hepatitis B in China since its launch one year ago; and the launch of Hengmu has broken the monopoly of imported drugs and contributed to the academic progress in the field of liver diseases in China.
Release of new data to prove excellent quality
The event was jointly held in six cities across China, at which the 96-week data from the large-scale Phase III clinical study of Hengmu (Tenofovir Amibufenamide Tablets) was released and interpreted in detail, and the participating experts had an in-depth exchange and discussion based on local diagnosis and treatment characteristics. This was a randomized, double-blind, non-inferiority clinical trial conducted at 49 research centers in China. With a total of 1,005 subjects enrolled, it studied the efficacy and safety results of Tenofovir Amibufenamide Tablets (TMF) versus tenofovir disoproxil fumarate (TDF) over 96 weeks.
Clinical data demonstrated that the response rate of HBV DNA (<20IU/ml) in TMF group was equivalent to that in TDF group, the ALT normalization rate in the total population and HBeAg-positive subjects was superior to that in TDF group, the decrease in bone mineral density from baseline was significantly superior to that in TDF group, and the decrease in eGFR from baseline was significantly superior to that in TDF group. The 96-week data from the large-scale Phase III clinical study reaffirmed the sustained efficacy and safety of Hengmu, providing a safe and efficient new option for the treatment of patients with CHB.
Hard work together to fulfill the ten-year commitment
Perseverance Makes Excellence; Care Creates New Life. Since its launch one year ago, Hengmu (Tenofovir Amibufenamide Tablets) has benefited more than 100,000 patients with CHB. On July 2, the 96-week data from the large-scale Phase III clinical study was released at the 15th National Clinical Academic Conference on Liver Diseases. As Hengmu is increasingly accepted and supported by clinicians, a number of investigator-initiated clinical studies have been carried out successively. In the All Ideas Matter session, experts from different regions exchanged views on the management of patients with hypotoxemia, the mechanism of TFV drugs on lipid metabolism, and the treatment and management of patients in immune tolerance period, and discussed the hot and difficult clinical issues. At the event, the interim report on the investigator-initiated Real World Study of TMF Combined with Peg-IFNα to Reduce CHB Surface Antigen Levels was also released for the first time.
According to Executive Director Mr. Lyu Aifeng, Hansoh Pharma will increase R&D investment in the clinical study of Hengmu, and will extend the large-scale Phase III clinical study to ten years; Hansoh Pharma looks forward to exploring more application scenarios as well as long-term efficacy and safety to help more CHB patients improve their quality of life and return to normal life. Upholding the corporate mission to create excellence in pharmaceuticals and enhance innovation in China, and always putting patients in the first place, Hansoh Pharma is committed to exploring and developing best practices in the prevention, treatment and drug R&D of chronic viral hepatitis, and will make unremitting efforts towards the Healthy China 2030 goal.
