Mabwell Secures US FDA IND Clearance for Anti-ST2 Antibody in COPD

Mabwell Secures US FDA IND Clearance for Anti-ST2 Antibody in COPD

By, Admin 26 December 2025

Mabwell has received IND clearance from the US FDA to advance its anti-ST2 monoclonal antibody, 9MW1911, into a Phase IIa clinical study for COPD.

This marks a key step in Mabwell’s global clinical strategy and expands the program beyond China.

Why This Matters?

COPD remains an area with high unmet medical need, especially for patients with frequent exacerbations.

By targeting the IL-33/ST2 signaling pathway, Mabwell is pursuing a novel inflammatory mechanism linked to disease severity and progression.

About 9MW1911: A First-in-Class Domestic Candidate

9MW1911 is Mabwell’s self-developed anti-ST2 monoclonal antibody.

  • Binds to the ST2 receptor with high affinity
  • Blocks IL-33/ST2 signaling involved in airway inflammation
  • First domestic anti-ST2 antibody to reach clinical trials

The asset has already completed a Phase IIa study in China.

Key Phase IIa Results from China

The China Phase IIa study enrolled 80 patients with moderate-to-severe COPD.

Safety and tolerability

  • Well tolerated across all dose groups
  • Adverse event rates comparable to placebo
  • No immunogenicity detected
  • No new safety signals observed

Pharmacokinetics

  • Drug exposure increased with dose escalation
  • Exposure-response relationship was established
  • Data supports rational dose selection

Promising Efficacy Signals

Clinical outcomes showed a clear dose-dependent benefit.

At the recommended Phase IIb dose (RP2D):

  • 30% reduction in annualized moderate-to-severe exacerbations
  • 40% reduction in annualized severe exacerbations
  • Fewer patients experienced severe exacerbations versus placebo

These results support further late-stage development.

What’s Next for the Program?

Mabwell has already initiated a Phase IIb trial.

  • First patient dosed in July 2025
  • Interim analysis planned after data from ≥120 patients
  • Phase III study expected to begin by end of 2026

The US IND clearance enables parallel global development.

The Bigger Picture

This milestone strengthens Mabwell’s respiratory pipeline and highlights its ability to advance novel biologics internationally.

By addressing inflammatory drivers beyond current COPD therapies, 9MW1911 could offer a differentiated treatment option for high-risk patients.

About Mabwell

Mabwell is an innovation-driven biopharmaceutical company with end-to-end development capabilities.

  • Focus areas: oncology and aging-related diseases
  • Mission: Explore Life, Benefit Health
  • Vision: Innovation, from Ideas to Reality

The company continues to expand its global clinical footprint through differentiated biologics.

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