By Fineline Cube Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKG: 1177), announced Phase II clinical trial results for TQC2938, a Class 1 innovative drug independently developed by the company, at the 2026 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress. The study evaluated the humanized IgG2 monoclonal antibody targeting ST2 in patients with moderate-to-severe seasonal allergic rhinitis (SAR), demonstrating promising efficacy and safety profiles.
Clinical Trial Overview
| Item | Detail |
|---|---|
| Conference | 2026 EAACI Annual Congress |
| Drug | TQC2938 – humanized IgG2 monoclonal antibody targeting ST2 |
| Developer | Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ) |
| Parent Company | Sino Biopharmaceutical Limited (HKG: 1177) |
| Indication | Moderate-to-severe seasonal allergic rhinitis (SAR) |
| Study Design | Phase II, randomized, placebo-controlled |
| Dose Groups | 210 mg, 420 mg, 630 mg |
Mechanism of Action & Innovation
- Target: ST2 protein – receptor for interleukin-33 (IL-33)
- Mechanism: Specifically binds to human ST2, blocking IL-33 interaction
- Therapeutic Advantage: Simultaneously inhibits both type 2 and non-type 2 inflammatory pathways involved in SAR pathogenesis
- Classification: Class 1 innovative drug (first-in-class in China)
- Differentiation: Novel approach addressing broader inflammatory spectrum compared to existing SAR therapies focused primarily on type 2 inflammation
Primary Endpoint Results – rTNSS Improvement
| Time Point | 420 mg Dose vs Placebo | p-value | Significance |
|---|---|---|---|
| 2 Weeks | -0.97 point improvement | 0.1166 | Not statistically significant |
| 4 Weeks | -1.37 point improvement | 0.0342 | Statistically significant |
The 420 mg dose group demonstrated the most pronounced overall efficacy among all dose groups tested, with statistically significant improvement in reflective Total Nasal Symptom Score (rTNSS) at 4 weeks.
Secondary Endpoint Results
The 420 mg dose group showed statistically significant improvements across all key secondary endpoints compared to placebo:
- rTNSS at 4 weeks: Significant improvement (p=0.0342)
- rTOSS (reflective Total Ocular Symptom Score) at 2 weeks: Significant improvement
- rTOSS at 4 weeks: Significant improvement
- RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) at 2 weeks: Significant improvement
- RQLQ at 4 weeks: Significant improvement
These comprehensive results demonstrate TQC2938’s ability to improve both nasal and ocular symptoms while enhancing patients’ quality of life.
Safety Profile
- Adverse Event Rate: 420 mg dose group showed favorable safety profile
- Comparison to Placebo: Overall adverse event rate comparable to placebo group
- Tolerability: No dose-limiting toxicities observed in the 420 mg cohort
- Safety Conclusion: Well-tolerated with no significant safety concerns identified
Market Impact & Strategic Significance
- SAR Market Opportunity: Global allergic rhinitis therapeutics market projected to reach USD 12.5 billion by 2028, with significant unmet need in moderate-to-severe cases
- Competitive Landscape: Current SAR treatments include antihistamines, intranasal corticosteroids, and leukotriene receptor antagonists; TQC2938 represents a novel biologic approach
- Therapeutic Gap: Existing biologics for allergic conditions primarily target type 2 inflammation; TQC2938’s dual pathway inhibition could address broader patient populations
- Commercial Potential: If approved, TQC2938 would be among the first ST2-targeting biologics globally for allergic rhinitis, positioning Chia Tai Tianqing as an innovator in immunology
The positive Phase II data support advancement to Phase III development, with the 420 mg dose identified as the optimal dose for further clinical evaluation.
Forward‑Looking Statements
This brief contains forward-looking statements regarding clinical development timelines, regulatory approvals, and commercial expectations for TQC2938. Actual results may differ due to risks including Phase III trial outcomes, regulatory decisions, competitive dynamics, and execution of Chia Tai Tianqing’s development strategy.-Fineline Info & Tech