By Fineline Cube Qyuns Therapeutics Co., Ltd. (HKG: 2509) announced that its self-developed long-acting bispecific antibody, QX027N Injection, received approval from China’s National Medical Products Administration (NMPA) for clinical trials intended to treat chronic obstructive pulmonary disease (COPD) and chronic rhinosinusitis with nasal polyps (CRSwNP).
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Clinical trial approval |
| Product | QX027N Injection |
| Indications | Chronic obstructive pulmonary disease (COPD) and chronic rhinosinusitis with nasal polyps (CRSwNP) |
| Approval Date | 31 Jul 2026 |
| Next Steps | Initiate Phase I/II clinical trials with safety and efficacy evaluation |
Drug Profile & Mechanism of Action
- Molecule: Potential best-in-class humanized IgG1 bispecific monoclonal antibody
- Targets: TSLP and IL-13 (two well-validated mature targets in immuno-inflammatory diseases)
- Affinity: Sub-picomolar affinity for both targets
- Innovation: Engineered to extend half-life, thereby reducing dosing frequency
- Development Status: Self-developed candidate with dual indication potential
Strategic Global Licensing Agreement
In December 2025, Qyuns entered into a license and collaboration agreement with LE2025 Therapeutics AG (a subsidiary of Windward Bio Group AG), granting LE2025 exclusive rights to develop and commercialize QX027N (Windward Bio R&D code: WIN027) worldwide, excluding Mainland China, Hong Kong, Macao, and Taiwan.
The collaboration structure includes upfront payments, development and regulatory milestones, and tiered royalties on net sales, positioning Qyuns to benefit from global commercial success while maintaining full control in the Greater China region.
Market Opportunity & Competitive Landscape
- Global COPD Burden: Affects an estimated 384 million people worldwide with limited treatment options for many patients
- CRSwNP Prevalence: Impacts approximately 2-4% of the general population with significant unmet medical need
- Market Size: Global COPD therapeutics market projected to reach $65.3 billion by 2028
- Competitive Edge: Bispecific approach offers potential advantages through simultaneous modulation of complementary inflammatory pathways compared to existing monospecific biologics
Company Strategy & Pipeline Vision
“This NMPA approval validates our innovative approach to developing next-generation biologics for complex respiratory diseases,” said Dr. Wei Zhang, Chief Executive Officer of Qyuns Therapeutics. “Our partnership with LE2025 Therapeutics combines our cutting-edge science with their global development expertise, creating an optimal pathway to bring this promising therapy to patients worldwide.”
Qyuns Therapeutics maintains a robust pipeline of bispecific antibody candidates targeting various inflammatory and autoimmune conditions, with QX027N representing the most advanced program in respiratory indications.
Forward‑Looking Statements
This brief contains forward-looking statements regarding clinical development timelines, regulatory approvals, partnership outcomes, and commercial expectations for QX027N. Actual results may differ due to risks including clinical trial outcomes, regulatory decisions, competitive dynamics, and partnership execution.-Fineline Info & Tech