SBP GROUP (01177): TQC3721 inhalation powder aerosol (PDE3/4 inhibitor) to announce Phase I clinical trial data at ERS 2026.

SBP GROUP (01177) announced that its subsidiary, Chengdu Jialin Pharmaceutical Group Co., Ltd. (Chengdu Jialin), has independently developed the TQC3721 dry powder inhaler (DPI) (PDE3/4 inhibitor), and two phase I clinical study data have been presented at the European Respiratory Society (ERS 2026) annual meeting. Abstract Title: Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study in COPD Patients Abstract Number: 376; Presentation Format: Poster session. This is a randomized, controlled, dose-escalation trial conducted in patients with chronic obstructive pulmonary disease (COPD), aimed at evaluating the safety, tolerability, and preliminary dose-response relationship 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, receiving escalating doses of TQC3721 DPI or placebo in 6 cohorts, with a dosing range of 125 g to 1.5 mg. On day 9 of treatment, the mean change from baseline in forced expiratory volume in the first second (FEV1) peak after administration of TQC3721 DPI showed a clear dose-dependent effect: 300.0 mL for the 125 g group, 288.9 mL for the 250 g group, 263.0 mL for the 500 g group, 344.0 mL for the 750 g group, 497.0 mL for the 1000 g group, and 410.0 mL for the 1500 g group. The study found that TQC3721 DPI significantly improved lung function in COPD patients and had good safety, with a similar incidence of adverse events across groups, 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; Presentation Format: Poster session. The second part of this phase I study is a randomized, open-label, positive-controlled proof-of-concept study aimed at evaluating the safety and preliminary efficacy of TQC3721 DPI in conjunction with Glycopyrrolate. The study is planned to enroll 40 COPD patients to receive various doses and frequencies of TQC3721 DPI combined with Glycopyrrolate, or to receive Indacaterol/Glycopyrronium (IND/GLY) dry powder inhaler as the positive control. At the time of submission, among the 23 patients who completed two weeks of treatment, the group receiving 1 mg TQC3721 (twice daily) combined with 50 g Glycopyrronium (once daily) demonstrated clinically significant improvements in lung function compared to IND/GLY: a 203 mL improvement in FEV1 trough value and a 110 mL improvement in FEV1 peak value compared to baseline. The study has now completed enrollment and observation of all 40 subjects, and the results are consistent with the published data, showing that the combination regimen of TQC3721 DPI and Glycopyrrolate exhibited comparable bronchodilatory effects to the dual bronchodilator IND/GLY, with good tolerability and an overall manageable safety profile for treatment-emergent adverse events (TEAEs). These results provide strong support for the development of fixed-dose combinations of TQC3721 DPI and LAMA. This fixed combination is referred to as a tri-functional dual bronchodilator. TQC3721 is a new mechanism PDE3/4 inhibitor developed independently by Chengdu Jialin, achieving symptom relief and inflammation suppression through dual mechanisms of bronchodilation and anti-inflammatory action. For COPD, the nebulized suspension form of TQC3721 has shown best-in-class potential in phase IIb studies, and this formulation is currently undergoing phase III clinical trials in China, having been included in the breakthrough therapy list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China; the phase II clinical trials for the dry powder inhaler also yielded positive topline data.