Chinese siRNA Innovator Xingyao Kunze's HT-101 Receives Second Breakthrough Therapy Designation in 2025

　　【Pharmaceutical Network Product InformationOn September 23, HT-101 Injection and HT-102 Injection, independently developed by Hepa Thera, were officially designated as breakthrough therapies for the treatment of chronic hepatitis B. This designation is based on the significant antiviral activity and favorable safety profile demonstrated in early clinical trials, offering the potential for an improved treatment option for patients.
 

Public information shows that HT-101 injection is an innovative siRNA drug conjugated with GalNAc. It achieves anti-HBV effects by specifically targeting the liver to silence HBV mRNA, thereby blocking the synthesis of multiple viral proteins.
 

HT-102 is a fully human monoclonal antibody targeting HBsAg, which can prevent HBV reinfection, eliminate subviral particles containing HBsAg in the circulating blood, and reduce subviral particle-mediated immunosuppression.
 

HT-101 Injection combined with HT-102 Injection theoretically targets HBsAg in peripheral blood and multiple HBV viral proteins in the liver simultaneously, with complementary mechanisms and potential synergistic effects.
 

Notably, this is the second time that HT-101 injection has been included in the breakthrough therapy designation following July this year. In July, HT-101 injection was granted the breakthrough therapy designation by the National Medical Products Administration (NMPA) of China. This designation is based on the significant antiviral activity and favorable safety profile demonstrated by the drug in early clinical trials, which is expected to offer an improved treatment option for patients.
 

On February 4 this year, Hepa Thera announced that the clinical trial application for its newly developed anti-hepatitis B drug HT-101 has been approved by the U.S. FDA, and it will directly proceed to Phase 1b clinical trials targeting chronic hepatitis B virus infection. The clinical trial showed that HBsAg levels in all dose groups continued to decline after two doses, with some patients in the high-dose group achieving HBsAg clearance (for more details: APASL2025: Results of Two Doses of Investigational Hepatitis B Drug HT-101 Followed by 48 Weeks Off-Treatment Announced).
 

Hepa Thera's published Phase 2 preliminary data further indicates that HT-101 outperforms similar competing products both domestically and internationally in terms of onset time and S antigen clearance rate.
 

So far, there are more than 10 investigational new drugs for the treatment of chronic hepatitis B in China that have been included in the breakthrough therapy designation category. In addition to the aforementioned varieties, it also includes GST-HG131 (RNA...Stabilizer), Canocapavir (ZM-H1505R), GST-HG141 (Capsid Assembly Modulator), JNJ-56136379 (JNJ-6379) Tablets (Capsid Assembly Modulator), Bepirovirsen (GSK3228836, GSK836) Injection (Antisense Oligonucleotide), AHB-137 Injection (Antisense Oligonucleotide), GSK5637608 (JNJ-73763989, JNJ-3989, Daplusiran/tomligisiran) Injection (RNAi Therapeutic), BRII-835 (VIR-2218) Injection (RNAi Therapeutic), BW-20507 (RNAi Therapeutic), BRII-179 (VBI-2601) Injection (Therapeutic Hepatitis B Vaccine), and BRII-877 (VIR-3434) for Injection (Neutralizing Antibody), etc.
 

From the progress, the antisense oligonucleotide Bepirovirsen (GSK3228836, GSK836) injection is expected to be launched in 2026, while other candidate products remain to be observed. The capsid assembly modulator JNJ-56136379 (JNJ-6379) tablets, which were included in China's breakthrough therapy list at a very early stage, have been discontinued due to efficacy not meeting expectations. The RNAi therapeutic drug JNJ-3989 (JNJ-73763989, GSK5637608, Daplusiran/tomligisiran, ARO-HBV) injection has been handed over to GSK due to Johnson & Johnson’s strategic adjustment.
 

Public information shows that Hepa Thera is a company incubated by Fosun Pharma's New Drug Fund, focusing on the development of innovative drugs in the field of liver disease treatment.
 

A biotechnology company. Based on technologies such as RNA interference, antibodies, fusion proteins, and gene editing, it is committed to addressing unmet needs in the treatment of liver diseases such as hepatitis B, non-alcoholic fatty liver disease, liver fibrosis, cirrhosis, and autoimmune liver diseases.
 

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