November 2025 – Biomissile Pharmaceuticals Co., Ltd. and Suzhou HepaThera Biotech Co. Ltd. announced positive results from a randomized, multicenter phase Ib/IIa study of BM012 (HT-102) in combination with HT-101 in patients with chronic hepatitis B (HBV). The data were presented as a Late-Breaking Presentation at the 76th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2025) in Washington, D.C.
Clinical data demonstrate substantial HBsAg reduction with favorable safety profile
The phase Ib/IIa study enrolled 56 NUC–suppressed, HBeAg-negative chronic hepatitis B patients with baseline HBsAg levels of 100–3,000 IU/mL across five treatment arms. In the combination cohorts (C–E), HBsAg loss was achieved in 22 of 28 patients (79%) by Week 24. In the high-dose E cohort, 9 of 10 patients (90%) achieved HBsAg loss by Week 20, including 2 patients who achieved HBsAg loss at Week 4. Maximum on-treatment HBsAg decline reached 4.6 log₁₀ IU/mL.
The regimen was well tolerated with no Grade ≥3 adverse events, no treatment-related serious adverse events, and no discontinuations. The most common adverse event was mild injection-site erythema.
Complementary mechanisms of action for strong synergistic treatment effects
BM012 (HT-102) is a fully human monoclonal antibody targeting hepatitis B surface antigen (HBsAg) developed by Biomissile. HT-101, developed by Suzhou HepaThera Biotech Co., Ltd., is a GalNAc-conjugated siRNA designed to reduce HBsAg production. The combination aims to lower antigen burden through complementary mechanisms.
Based on these results, the BM012 (HT-102) + HT-101 combination received Breakthrough Therapy designation from NMPA on September 23, 2025. A Phase IIb randomized controlled trial is currently underway, with post-treatment follow-up data expected in the first half of 2026.
“BM012 (HT-102) is a direct outcome of our fully human antibody discovery platform, and this milestone reflects our strength of developing highly differentiated biologics for diseases with a high global burden, such as chronic hepatitis B.” said Dr. Chao Tu, CEO of Biomissile. “We are encouraged by the depth and consistency of HBsAg loss observed in this study,” Dr. Tu added. “We look forward to continuing development with our partner Suzhou HepaThera as we advance this combination into later-stage trials.”
About Biomissile Pharmaceuticals
Biomissile Pharmaceuticals is a clinical-stage biotech company developing fully human domain antibody (UDABTM)-based multi-specific antibodies (UDAB-MTM) for solid tumors, autoimmune diseases, and infectious diseases. Leveraging these proprietary platform technologies, we have developed our UDAB-M Immune Cell Engager (ICE) platform and built a highly differentiated pipeline that selectively activates NK and T cells, effectively targeting cold tumors, including TAA-low and ADC-resistant solid tumors. In addition to oncology, UDAB-M molecules have been successfully expanded into autoimmune diseases, where they have demonstrated best-in-class potential for B cell depletion and multi-pathway immune blockade.
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