Sino Biopharmaceutical Limited (SBP Group) announced that China’s National Medical Products Administration has approved a clinical trial application for IM-101, a PreS1 recombinant fusion protein intended to treat chronic hepatitis B (CHB).

IM-101 is designed to break immune tolerance and re-establish HBV-specific immune responses. At the humoral level, PreS1-specific antibodies generated by the therapy are expected to neutralise viral particles and block their entry into hepatocytes by preventing binding to NTCP receptors. At the cellular level, the candidate aims to activate HBV-specific T-cell responses, clearing infected liver cells through cytolytic and non-cytolytic mechanisms. These combined actions position IM-101 as a potential contributor to a “functional cure”, defined as sustained clearance of HBsAg and HBV DNA after finite therapy.

Unmet need remains significant: around 290 million people worldwide live with chronic HBV infection, including approximately 75 million in China. Current standards of care—nucleos(t)ide analogues and interferons—achieve HBsAg seroclearance rates of only 0–3% and 3–7%, respectively, and often require long-term administration.

IM-101 complements SBP Group’s expanding liver-disease pipeline. Key programmes include: • Lanifibranor (pan-PPAR agonist), in a global Phase III trial for metabolic dysfunction-associated steatohepatitis. • TQA3605 (HBV core protein allosteric modulator), cleared by the CDE for Phase III development. • TQ-A3334 (TLR-7 agonist) and Kylo-0603 (THR-β agonist), both in Phase II trials. • A strategic collaboration with GSK on Bepirovirsen; the marketing application in China has priority review status.

The newly approved study of IM-101 further strengthens SBP Group’s multi-mechanism approach to tackling CHB and related liver diseases.