Hepalatide, the first-in-class new drug for hepatitis B developed by Shanghai Hepu Pharmaceutical Co., Ltd., has recently obtained the default approval of NMPA clinical trial and successfully entered the stage of phase II/III clinical research and development. It marks the important progress of independent research and development of new drugs for hepatitis B treatment in China, and is expected to achieve the degree of cure of chronic hepatitis B (pa). TiAl cure, and even clinical cure. Randomized double-blind placebo-controlled phase I clinical study showed that the drug had good safety and pharmacodynamic response. Phase II/III clinical study of hepatitis B treatment with persistent virological response as the main end point after discontinuation of the drug will be launched. Academician Wang Fusheng, Fifth Medical Center of PLA General Hospital, will be the primary research subject in the clinical trial. Researcher.
In 2017, the European Society of Hepatology (EASL) defined the non-detection of HBV DNA at least six months after the end of hepatitis B treatment as a degree of cure, and the negative conversion of HBsAg at least six months after the end of treatment as a clinical cure. At present, only nucleoside (acid) and interferon are approved for the treatment of chronic hepatitis B. Nucleoside (acid) drugs need to be taken for a long time. HBV DNA usually rebounds after withdrawal. Interferon was given for 48-72 weeks. After 6 months of treatment, the degree cure rate and clinical cure rate were only 7% and 2%. There was a huge gap between the goal of WHO to eliminate viral hepatitis by 2030. Curing hepatitis B has become a common goal of new hepatitis B drugs worldwide.
