Hepathera’s HT-101 Injection in Combination with HT-102 Injection Granted Breakthrough Therapy Designation by NMPA

HT-101 is a novel GalNAc‑conjugated siRNA therapeutic designed to achieve highly specific liver targeting. It silences hepatitis B virus (HBV) mRNA, thereby blocking the synthesis of multiple viral proteins to exert anti‑HBV effects. HT-102 is a fully human anti‑HBsAg monoclonal antibody (IgG1, kappa) that prevents HBV reinfection, clears circulating subviral particles containing HBsAg, and reduces subviral particle‑mediated immune suppression.

The combination of HT-101 and HT-102 is theoretically complementary in mechanism, targeting both peripheral blood HBsAg (via HT-102) and multiple HBV proteins within the liver (via HT-101), with potential synergistic efficacy. In the Phase 1b trial of HT-101, all dose groups demonstrated sustained declines in HBsAg levels after two doses, and some patients in the high‑dose group achieved HBsAg loss. Preliminary Phase 2 data further indicate that the HT-101 + HT-102 combination is significantly superior to comparable products both domestically and internationally, in terms of both speed of onset and HBsAg clearance rate.

The Phase 2 clinical trial of HT-101 in combination with HT-102 is currently ongoing at multiple study sites across China. The Breakthrough Therapy Designation is expected to accelerate clinical development, addressing the urgent unmet medical needs in the chronic hepatitis B field both in China and globally.