Tides Express | Xingyao Kunze's siRNA Drug Receives NMPA Breakthrough Therapy Designation

Jul 11, 2025 14:07 CST Updated 14:07

Hepa Thera

Innovative Drug Developer in the Field of Hepatology

｜Edited by the Content Team of Zhong Peptide Biochemical

2025July 10DaySuzhou Hepa Thera Biotech Co., Ltd. (hereinafter referred to as "Hepa Thera") independently developed HT-101 injection, which has been included in the breakthrough therapy drugs for the treatment of chronic hepatitis B virus infection. This designation is based on the drug's significant antiviral activity and good safety demonstrated in early clinical trials, offering the potential for an improved treatment option for patients.

HT-101 is an innovative GalNAc-conjugated siRNA drug that achieves anti-HBV effects by specifically targeting the liver to silence HBV mRNA, blocking the synthesis of multiple viral proteins. Its clinical advantages are significant. Phase 1b clinical trials showed that HBsAg levels in all dose groups continued to decline after two administrations, with some patients in the high-dose group achieving HBsAg clearance. Preliminary phase 2 data further indicates that HT-101 outperforms similar competing products both domestically and internationally in terms of onset time and S antigen clearance rate.

Currently, the most important 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 HBV (hepatitis B virus) 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, require daily administration, and patient compliance tends to be poor.

The ultimate treatment goal for hepatitis B is to achieve functional cure or even complete cure, but currently there are no clinical treatments that can reach this goal. There is still a huge 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.

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.

Source:

1.Hepa Thera