By Fineline Cube Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Category 1 drug TQA3605 has met the primary endpoint in a Phase II study for patients with chronic hepatitis B virus (HBV) infection. The HBV core protein allosteric modulator (CpAM) demonstrated ~90% viral suppression when combined with nucleos(t)ide analogues (NAs), with no similar product approved globally.
Clinical Trial Results & Regulatory Status
| Item | Detail |
|---|---|
| Company | Sino Biopharmaceutical Ltd (HKEX.01177) |
| Drug | TQA3605 (HBV core protein allosteric modulator) |
| Indication | Chronic hepatitis B virus (HBV) infection |
| Trial | Phase II, Category 1 drug |
| Mechanism | Inhibits multiple HBV genotypes, no cross‑resistance with NAs |
| Primary Endpoint | HBV DNA <20 IU/mL at 24 weeks |
| Efficacy | ~90% response rate (all dose groups) vs. control (p < 0.0001) |
| Safety | Favorable profile, adverse reaction rate comparable to control |
| Strategic Significance | No approved CpAM worldwide; first‑in‑class potential |
Drug Profile & Competitive Advantage
- Mechanism: TQA3605 targets HBV core protein, disrupting viral capsid assembly and preventing viral replication across multiple genotypes
- Differentiation: No cross‑resistance with existing nucleos(t)ide analogues, enabling combination therapy for patients with residual viremia despite NA treatment
- Patient Population: Adult chronic HBV patients who received NA therapy for ≥12 months with low‑level viremia
- Unmet Need: ~300 million chronic HBV patients globally, with 30–50% experiencing incomplete viral suppression on NA monotherapy
- Global Landscape: First CpAM to demonstrate robust efficacy; positions Sino Biopharm ahead of Roche, Johnson & Johnson, and Assembly Biosciences in HBV functional cure race
Market Impact & Commercial Outlook
- China HBV Market: Valued at ¥20 billion : (~US$2.8 billion) in 2025, growing at 8% CAGR driven by screening programs and treatment expansion
- Revenue Potential: Analysts project ¥3–5 billion (US$420–700 million) peak annual sales if approved, based on first‑mover advantage and combination therapy positioning
- Strategic Value: Phase II success validates platform for HBV functional cure; may attract global partnership interest
- Regulatory Pathway: Category 1 status enables priority review; NDA submission targeted for 2027
- Next Steps: Phase III trial design discussions with NMPA; global development strategy under evaluation
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for TQA3605. Actual results may differ due to clinical trial outcomes, competitive dynamics, and NMPA review processes.-Fineline Info & Tech