China Biopharmaceutical (01177): TQC3721 inhalation powder (PDE3/4 inhibitor) released phase I clinical study data in ERS 2026

Zhitong Finance App News, China Biopharmaceutical (01177) announced that the TQC3721 inhalation powder (DPI) (PDE3/4 inhibitor) independently developed by Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Chia Tai Tianqing), a subsidiary of the Group, has published 2 phase 1 clinical study data at the 2026 meeting of the European Respiratory Society (ERS 2026).

Abstract Title: Safety and Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Controlled Study in COPD Patients

Abstract Number: 376; Report Form: Poster Session.

This is a randomized, controlled, dose-escalation test conducted in patients with chronic obstructive pulmonary disease (COPD) to evaluate the safety, tolerability, and initial dose-efficacy relationships of TQC3721 DPI in patients with moderate to severe COPD. It is the first part of its phase I clinical trial. A total of 72 patients were included in the study and each received an incremental dose of TQC3721 DPI or placebo in 6 cohorts. The dosage range was 125 μg to 1.5 mg.

On the 9th day of treatment, the first second of TQC3721 DPI after administration of each dose group showed clear dose-dependence: 300.0 mL for the 125 μg group, 288.9 mL for the 250 μg group, 263.0 mL for the 500 μg group, 344.0 mL for the 750 μg group, 497.0 mL for the 1000 μg group, and 410.0 mL for the 1500 μg group. The study found that TQC3721 DPI can significantly improve lung function in COPD patients and is safe. The incidence of adverse events in each group is similar, supporting its further clinical development.

Abstract Title: Late Breaking Abstract - A Randomized, Open-Label, Active-Controlled Phase I Study of Inhaled Dual PDE3/4 Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in Patients With COPD

Abstract number: 4853; Report format: poster session.

The second part of this phase I study was a randomized, open, positive drug-controlled proof-of-concept study. The purpose of the study was to evaluate the safety and initial efficacy of the combined use of TQC3721 DPI and glyconium bromide. The study plans to include 40 COPD patients who each received TQC3721 DPI in combination with glyconium bromide at different doses and frequencies, or indaterol/glyonium bromide (IND/GLY) inhaled powder as positive controls.

At the time of submission, among 23 patients who had completed 2 weeks of treatment, the 1 mg TQC3721 (twice daily) combined with 50 μg glyronium bromide (once daily) group showed clinically significant improvements in lung function: FEV1 valley improved 203 mL from baseline, and FEV1 peak improved 110 mL from baseline compared to baseline.

At present, all 40 subjects have been enrolled and observed in the study. The study results are basically consistent with the published data. The combined dosage regimen of TQC3721 DPI and glyonium bromide showed a bronchodilator effect comparable to the dual bronchodilator IND/GLY, and was well tolerated, and the adverse events (TEAEs) that occurred during treatment were generally safe and controllable. These results provide strong support for the development of fixed-dose combination formulations of TQC3721 DPI and LAMA. This fixed compound preparation is known as a tri-functional double dilator.

TQC3721 is a new mechanism PDE3/4 inhibitor independently developed by Chia Tai Tianqing. It achieves the goal of reducing symptoms and suppressing inflammation through the dual mechanism of bronchodilation and anti-inflammatory. For COPD, tQC3721 atomized inhalation suspension has shown the best potential in its class in phase IIb studies. Currently, this dosage form is undergoing phase III clinical trials in China and has been included in the list of breakthrough therapeutic agents by the China National Drug Administration Drug Evaluation Center (CDE); phase 2 clinical trials of dry powder inhalation powders have also obtained positive top-line data.