By Fineline Cube Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (HKG: 3378) announced the initiation of a Phase I clinical trial for its self‑developed candidate HX111, an OX40‑targeting antibody‑drug conjugate (ADC), in patients with relapsed or refractory lymphoma and solid tumors. HX111 is the first disclosed OX40‑targeting ADC worldwide to enter clinical stage.
Regulatory Milestone & Drug Profile
| Item | Detail |
|---|---|
| Company | Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (3378.HK) |
| Drug | HX111 |
| Mechanism | OX40‑targeting antibody‑drug conjugate (ADC) |
| Indication | Relapsed or refractory lymphoma and solid tumors |
| Clinical Stage | Phase I trial initiated |
| Innovation | First disclosed OX40‑targeting ADC worldwide to enter clinical stage |
| Target | OX40 molecules highly expressed on certain lymphomas and solid tumors |
| Mechanism of Action | High‑affinity OX40 binding → endocytosis → lysosomal protease cleavage → payload release → tumor cell apoptosis |
Mechanism of Action & Clinical Rationale
- OX40 Targeting: HX111 binds with high affinity and specificity to OX40 molecules on tumor cell surfaces
- Efficient Delivery: Enters tumor cells via endocytosis; linker cleaved by lysosomal proteases to release potent payload
- Therapeutic Potential: OX40 is highly expressed in certain lymphomas and solid tumors lacking effective treatment options, addressing significant unmet clinical need
- Clinical Need: Relapsed/refractory lymphoma and solid tumor patients have limited salvage therapy options; OX40 ADC offers novel immunotherapy approach
Market Impact & Commercial Outlook
- Lymphoma & Solid Tumor Market: China market for relapsed/refractory lymphoma and solid tumors exceeds ¥80 billion (~US$11 billion) annually
- OX40 ADC Landscape: HX111 is first‑in‑class globally; positions Hanx as pioneer in OX40‑targeted therapy
- Revenue Potential: Analysts project ¥2–4 billion (US$280–560 million) peak annual sales if approved, based on orphan drug pricing and high unmet need
- Strategic Value: Validates Hanx’s ADC platform for novel targets; could attract global partnership interest
- Next Steps: Phase I dose‑escalation trial expected Q2 2026; early efficacy data anticipated H2 2027
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and revenue projections for HX111. Actual results may differ due to clinical trial outcomes, competitive dynamics, and regulatory review processes.-Fineline Info & Tech