SBP GROUP (01177.HK): Phase I data of TQC3721 dry powder inhaler (PDE3/4 inhibitor) presented at ERS 2026, showing dose-dependent lung function improvement in COPD

NewTimeSpace News: On 7 September 2026, Sino Biopharmaceutical Limited (stock code: 01177) voluntarily announced that TQC3721 dry powder inhaler (DPI), a PDE3/4 inhibitor independently developed by the group's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. , had two Phase I clinical study datasets presented at the European Respiratory Society International Congress 2026 (ERS 2026).

The first study (abstract no. 376, poster session), Part 1 of the Phase I program, was a randomized, double-blind, placebo-controlled, dose-ranging study in COPD patients evaluating the safety, tolerability and preliminary dose-response of TQC3721 DPI in patients with moderate-to-severe COPD. A total of 72 patients were enrolled across six cohorts receiving escalating doses of TQC3721 DPI (125 μg to 1.5 mg) or placebo. At Day 9 of treatment, mean changes from baseline in peak FEV1 showed a clear dose-dependent pattern, ranging from 263.0 mL in the 250 μg group to 497.0 mL in the 1000 μg group, demonstrating marked lung function improvement with a favorable safety profile.

The second study (abstract no. 4853, Late Breaking Abstract), Part 2 of the Phase I program, was a randomized, open-label, active-controlled proof-of-concept study evaluating the safety and preliminary efficacy of TQC3721 DPI combined with glycopyrronium bromide in 40 planned COPD patients, with indacaterol/glycopyrronium (IND/GLY) DPI as the active control. Among 23 patients completing two weeks of treatment at the time of submission, the group receiving 1 mg TQC3721 twice daily plus 50 μg glycopyrronium once daily showed clinically meaningful lung function improvements versus IND/GLY, with FEV1 trough improving 203 mL and FEV1 peak improving 110 mL from baseline. All 40 patients have completed enrollment and observation, with results broadly consistent with the published data; the combination demonstrated bronchodilation comparable to the dual bronchodilator IND/GLY with good tolerability, supporting the development of a fixed-dose combination of TQC3721 DPI with a long-acting muscarinic antagonist, a trifunctional dual bronchodilator.

The announcement noted that TQC3721 is a first-in-class PDE3/4 inhibitor that relieves symptoms and suppresses inflammation through dual bronchodilation and anti-inflammatory mechanisms. Its nebulized suspension formulation has shown best-in-class potential in a Phase IIb study, is currently in Phase III in China and has been included in the CDE's breakthrough therapy designation list, while the Phase II trial of the DPI formulation has also achieved positive topline data.

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