Hepathera's Innovative Combination Therapy for Chronic Hepatitis B Receives FDA Approval to Initiate Phase II Clinical Trial
On January 19, 2026, Hepathera announced that the Company’s Phase II investigational new drug (IND) application for the combination of its self‑developed HT‑101 and HT‑102 has been cleared by the U.S. Food and Drug Administration (FDA) for the Phase II.
HT-101 Injection and HT-102 Injection are two anti‑hepatitis B virus drugs developed by Hepathera. HT-101 is a GalNAc‑conjugated small interfering RNA (siRNA) designed to target hepatocytes, enabling precise silencing of HBV transcripts and blocking HBsAg production at the source. HT-102 is a fully human neutralizing antibody that rapidly captures and clears HBsAg from the blood, helping the body restore immune recognition. The combination of the two forms a closed‑loop therapeutic model of “suppression + clearance,” significantly enhancing cure efficacy.
Hepathera’s two anti‑hepatitis B virus drugs, HT‑101 and HT‑102 in combination, have demonstrated promising results in a Phase II study in China, achieving a hepatitis B surface antigen (HBsAg) clearance rate of up to 90% within 20 weeks—setting a new record for HBsAg clearance in this field.
Looking ahead, Hepathera will continue to be guided by science, delve deeply into global disease areas, and interpret its responsibility and commitment with more groundbreaking achievements, bringing high‑quality, affordable innovative treatment options to patients worldwide.
