Tides Brief | Xingyao Kunze's Hepatitis B siRNA Drug HT-101 Shows Promising Clinical Progress and Files for IPO

November 2024Day 8Hepa Thera announces positive updates from the clinical trial of its chronic hepatitis B siRNA new drug HT-101. The latest 48-week follow-up data reveal the drug's significant effect in reducing hepatitis B surface antigen (HBsAg) levels, with particularly impressive performance observed under low-dose administration.

Trial data showed that most participants in the HT-101 dosing group who were followed up during the extended period maintained a good reduction in HBsAg at 48 weeks. Particularly noteworthy was that in the 400mg dose group, one participant achieved HBsAg clearance with levels declining to undetectable by 48 weeks after receiving only two doses.

Currently, the most widely used first-line clinical drugs for chronic hepatitis B are nucleoside analogs, such as Lamivudine, Entecavir, Adefovir, Telbivudine, and Tenofovir Alafenamide. The mechanism of action of this class of drugs is to integrate into the viral DNA via the hepatitis B virus (HBV) reverse transcriptase, causing termination of DNA chain replication, thereby reducing HBV DNA. Although nucleoside analogs can effectively control the condition, once the medication is stopped, the virus may rebound. These drugs cannot eliminate the virus and require daily administration, leading to poor patient compliance.

The ultimate treatment goal for hepatitis B is to achieve functional cure or even complete cure. Currently, there are no clinical treatments that have reached this goal. There remains a significant unmet clinical need for achieving functional cure of hepatitis B. However, the emergence of RNA interference (RNAi) technology has shown great potential for realizing the functional cure of hepatitis B.

HT-101 Injection is the first domestically produced anti-hepatitis B siRNA (small interfering RNA) in China to enter the clinical stage, and it is an innovative GalNAc-conjugated siRNA drug. HT-101 interferes with hepatitis B virus mRNA, disrupting its function as a post-transcriptional translation template, preventing the synthesis of related viral proteins, thereby inhibiting the formation of hepatitis B virus particles, for the treatment of chronic hepatitis B virus infection.

In September 2022, the clinical trial application for HT-101 for the treatment of chronic hepatitis B virus infection (CHB)(IND) has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

AboutHepa Thera

Suzhou Hepa Thera Biotech Co., Ltd. was established in May 2021. It is a biotechnology company incubated by Fosun Pharma's New Drug Fund, focusing on the development of innovative drugs in the field of liver disease treatment. Hepa Thera leverages technologies such as RNA interference, antibodies, fusion proteins, and gene editing to address unmet needs in the treatment of liver diseases, including hepatitis B, non-alcoholic fatty liver disease, liver fibrosis, cirrhosis, and autoimmune liver diseases. The company collaborates with universities, research institutions, and biotechnology enterprises, developing products through models such as joint development, commissioned research, licensing, and independent research and development. It is expected to grow into an innovative enterprise with significant influence in China's liver disease treatment field.