Sino Biopharmaceutical Limited (SBP Group, 01177) disclosed encouraging Phase I clinical data for its in-house dual PDE3/4 inhibitor, TQC3721 dry-powder inhaler (DPI), at the European Respiratory Society 2026 Annual Meeting. The compound is being developed by subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ) for the treatment of chronic obstructive pulmonary disease (COPD).
First Phase I dose-escalation study • Design: Randomised, double-blind, placebo-controlled trial involving 72 COPD patients across six escalating dose cohorts (125 µg–1.50 mg). • Efficacy: On Day 9, mean change from baseline in peak FEV₁ showed a clear dose-response, ranging from 263.00 mL (500 µg) to 497.00 mL (1,000 µg). The 125 µg, 250 µg, 750 µg and 1.50 mg cohorts recorded 300.00 mL, 288.90 mL, 344.00 mL and 410.00 mL improvements, respectively. • Safety: Adverse-event rates were comparable to placebo across all dose groups, supporting continued clinical development.
Second Phase I combination study • Design: Randomised, open-label, active-controlled proof-of-concept study comparing TQC3721 DPI plus glycopyrronium bromide with indacaterol/glycopyrronium (IND/GLY) in 40 COPD patients. • Interim read-out (23 patients, two-week treatment): The regimen of TQC3721 1 mg twice daily combined with glycopyrronium 50 µg once daily achieved a 203 mL increase in trough FEV₁ and a 110 mL rise in peak FEV₁ versus baseline, outperforming the IND/GLY control. • Final data: All 40 subjects have completed follow-up; overall results aligned with interim observations, indicating bronchodilator efficacy comparable to IND/GLY and generally mild, manageable treatment-emergent adverse events.
Clinical programme status TQC3721’s nebulised suspension is already in a Phase III trial in China after demonstrating best-in-class potential in earlier studies and securing Breakthrough Therapy designation from the NMPA’s Centre for Drug Evaluation. The positive Phase I DPI findings strengthen the rationale for advancing a fixed-dose TQC3721-plus-LAMA “triple-action dual bronchodilator” formulation.
The Board characterises these data as supportive evidence for progressing TQC3721 DPI through subsequent clinical phases to address unmet needs in COPD management.