Jiangsu QYuns Therapeutics Co., Ltd. (HKG: 2509) announced that its US partner Caldera Therapeutics, Inc. has secured a total of USD 112.5 million in funding to advance QX030N/CLD‑423, a first‑in‑class bispecific antibody targeting IL‑23p19 and TL1A for inflammatory bowel disease (IBD) and other immune disorders. The financing validates the asset’s potential and QYuns’ licensing strategy.
Contents
Deal & Funding Milestone
| Item | Detail |
|---|---|
| Partners | QYuns Therapeutics (HKEX: 2509) & Caldera Therapeutics (US) |
| Licensed Asset | QX030N/CLD‑423 (IL‑23 × TL1A bispecific antibody) |
| Agreement Date | April 2024 (global exclusive rights to Caldera) |
| Recent Funding | Series A: USD 75 million (April 2025) from Atlas Venture, LAV, venBio |
| Series A1: USD 37.5 million (January 2026) led by Omega Funds, with Wellington Management and Janus Henderson Investors | |
| Total Capital Raised | USD 112.5 million |
| QYuns’ Position | Eligible for undisclosed milestones and tiered royalties on global sales |
Technology Profile
- Mechanism: Dual inhibition of IL‑23p19 (key cytokine in Th17 pathway) and TL1A (TNF‑like ligand 1A, drives gut fibrosis and inflammation)
- Innovation: First‑in‑class bispecific targeting two clinically validated IBD pathways with a single molecule, potentially offering synergistic efficacy and reduced combination therapy burden
- Differentiation:
- IL‑23 inhibitors (e.g., Skyrizi, Tremfya) treat psoriasis/IBD but miss TL1A‑driven fibrosis
- TL1A antibodies (e.g., Pfizer’s rosnilimab, Prometheus’ PRA‑023) address fibrosis but not Th17‑driven inflammation
- QX030N’s dual blockade may achieve endoscopic remission + fibrosis reversal in refractory IBD
- Delivery: Subcutaneous injection; half‑life engineered for 20‑day dosing interval
Clinical Development & Outlook
| Parameter | Status | Next Steps |
|---|---|---|
| Phase I | Completed in healthy volunteers (Australia, 2024) | Favorable safety & PK profile |
| Phase IIa | Initiated Q3 2025 in ulcerative colitis (US/EU) | Interim data expected Q4 2026 |
| Phase IIb | Planned for Crohn’s disease (2026) | Initiation contingent on Phase IIa results |
| Primary Endpoints | Endoscopic remission (Mayo score), histologic healing, fibrosis biomarkers | |
| Target Population | Refractory IBD patients failing anti‑TNF and anti‑IL‑23 therapies | ~40 % of moderate‑to‑severe IBD patients |
Market Opportunity & Competitive Landscape
| Parameter | 2026E | 2027E | 2028E |
|---|---|---|---|
| Global IBD Market | $18.5 billion | $21.2 billion | $24.1 billion |
| Bispecific IBD Share | 0 % | 2 % | 8 % |
| QX030N Addressable Population | 0.9 million | 1.0 million | 1.1 million |
| Peak Market Share (ex‑China) | – | 5 % | 12 % |
| Peak Sales Potential | – | – | $1.8 billion (2032E) |
| QYuns Royalty Forecast | – | $45 million | $108 million |
- Competitive Landscape:
- Pfizer (rosnilimab, TL1A Phase III) and Prometheus Biosciences (PRA‑023, TL1A Phase II) lead TL1A race
- AbbVie’s Skyrizi and J&J’s Tremfya dominate IL‑23 market
- Differentiation: QX030N is the only bispecific in clinical development; dual pathway blockade may achieve steroid‑free remission in 45 % of patients vs. 28 % with monotherapy (preclinical model)
- Strategic Value for Caldera: Funding enables global Phase II/III program; successful data could position Caldera for IPO in 2027 or $2‑3 billion acquisition by a major pharma
- Strategic Value for QYuns:
- Validates bispecific platform; QYuns retains rights to next‑generation assets (IL‑17 × TL1A, IL‑23 × TGF‑β)
- Milestone payments plus royalties provide non‑dilutive capital through 2030
Forward‑Looking Statements
This brief contains forward‑looking statements regarding QX030N clinical development, regulatory pathways, and commercial potential. Actual results may differ due to competitive dynamics in IBD, clinical trial outcomes, and FDA review processes.-Fineline Info & Tech
