Hepa Thera's HT101 Secures Breakthrough Therapy Designation from China CDE for Chronic Hepatitis B

SHANGHAI - July 16, 2025 - PRLog -- Shanghai, China – July 16, 2025 – Hepa Thera, a clinical-stage biotech innovator focused on curing liver diseases, today announced that HT101, its lead GalNAc-siRNA therapeutic, has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B (CHB).

The designation was based on preliminary Phase 2a clinical data showing that HT101, as a monotherapy, achieved robust reductions and clearance of hepatitis B surface antigen (HBsAg) without the use of immunomodulatory agents. These results position HT101 as a potential best-in-class siRNA monotherapy capable of delivering a functional cure.

"This designation marks a pivotal inflection point for Hepa Thera and the broader HBV field," said Stephen, CEO of Hepa Thera. "HT101 has demonstrated the kind of standalone efficacy rarely seen in RNAi-based therapies."

In the same study, HT101 combined with HT102—a proprietary neutralizing antibody—achieved even deeper and faster HBsAg suppression, highlighting strong mechanistic synergy. Based on these promising results, Hepa Thera is preparing to seek a separate Breakthrough Therapy Designation for the combination regimen.

About Breakthrough Therapy Designation in China

China's Breakthrough Therapy Designation is designed to expedite the development and regulatory review of therapies that offer substantial clinical advantages for serious or life-threatening conditions. The designation provides sponsors with priority interactions with the CDE, faster clinical development timelines, and streamlined regulatory review pathways.

About HT101 and HT102

HT101 is a GalNAc-conjugated siRNA designed to silence hepatitis B viral transcripts in hepatocytes with high specificity and durability. HT102 complements HT101 by mediating the clearance of circulating viral proteins through a neutralizing antibody mechanism, thereby restoring immune recognition and control.

Together, the two agents constitute a rational, multi-mechanism approach aimed at delivering a durable functional cure for the millions living with chronic hepatitis B.

About Hepa Thera

Headquartered in Shanghai, Hepa Thera was founded through Fosun Health Capital's innovation incubator, taking inspiration from the Flagship Pioneering model. The company is building a robust pipeline of curative therapies targeting hepatitis B, hepatitis D, MASH, and liver fibrosis, powered by advanced platforms in siRNA, monoclonal antibodies, and mRNA-based immunotherapy.

Contacts: heyajun@hepathera.com