By Fineline Cube 
Mabwell Bioscience (SHA: 688062) announced that its proprietary monoclonal antibody 9MW3811 has received clearance from the China National Medical Products Administration (NMPA) to commence a Phase 2 clinical study focused on pathological scarring. 9MW3811 is the first IL‑11‑targeting therapeutic to reach clinical development for this indication.
Deal & Development Milestones
| Milestone | Detail |
|---|---|
| Regulatory Milestone | NMPA approval to start Phase 2 trial (pathological scarring) |
| Indication | Pathological scarring (keloid, hypertrophic scar) |
| Drug Class | Category 1 therapeutic biologic – humanized anti‑IL‑11 IgG |
| Previous Indications | Advanced malignant tumors, idiopathic pulmonary fibrosis (Phase 1 completed) |
| Phase 1 Results | Good safety, half‑life > 30 days in Australia & China |
| Planned Start | Late 2025 (China) |
| Company | Mabwell (688062.SH) |
| Announcement Date | 11 Nov 2025 |
Scientific Rationale
- Target: Interleukin‑11 (IL‑11) / IL‑11Rα signaling, a key driver of fibroblast activation and extracellular‑matrix deposition in fibrotic diseases.
- Mechanism: 9MW3811 binds IL‑11 with picomolar affinity, blocking downstream STAT3‑mediated transcription that fuels scar formation.
- Pre‑clinical Evidence:
- Pulmonary fibrosis models: Significant reduction in collagen deposition and lung stiffness.
- Human‑derived keloid xenograft models: ↓ scar volume > 45 % and marked histologic reversal of fibrosis.
- Uterine bleeding models: Attenuated endometrial fibrosis, suggesting broader gynecologic utility.
Market & Competitive Landscape
- Unmet Need: Pathological scarring affects ≈ 30 million patients worldwide, with limited therapeutic options beyond surgery and corticosteroids.
- Potential Revenue: Global scar‑treatment market projected to exceed $5 billion by 2030; a disease‑modifying biologic could capture a double‑digit share.
- Competitive Edge: 9MW3811 is the only IL‑11‑targeted agent in clinical development, positioning Mabwell as a first‑mover in a novel fibrosis pathway.
Financial & Investor Implications
- R&D Funding: Mabwell earmarks RMB 300 million (≈ US$42 million) for the Phase 2 program, funded largely from existing cash reserves and a recent private placement.
- Share Reaction: Shanghai‑listed shares rose ≈ 4.1 % in early trading, reflecting investor confidence in the differentiated mechanism.
- Future Outlook: Successful Phase 2 read‑out could unlock global Phase 3 partnerships and accelerate licensing discussions with multinational pharma seeking anti‑fibrotic pipelines.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the development timeline, regulatory expectations, and commercial potential of 9MW3811. Actual results may differ due to risks including clinical trial outcomes, regulatory approvals, and market acceptance.-Fineline Info & Tech