A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD

Inclusion Criteria:

1. Males and females of Chinese ethnicity, at least 40 years of age.

2. Patients with with a clinical diagnosis of moderate to severe COPD confirmed byspirometry according to according to GOLD criteria 2023.

3. Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC (ForcedVital Capacity) < 0.70 at visit 1.

4. Modified Medical Research Council (mMRC) grade of at least 2 at visit 1.

Exclusion Criteria:

1. Patients with any of the following diseases:α-1 antitrypsin deficiency, asthma,active pulmonary tuberculosis, lung cancer, pulmonary edema, cystic fibrosis,obliterated bronchiolitis, sarcoidosis, or other diseases that the investigatorconsiders to be at risk of safety/efficacy for the patient, e.g lung fibrosis,pulmonary hypertension, interstitial lung disorder, active bronchiectasis.

2. Patients with a history of serious cardiovascular disease;

3. Patients with Type I or uncontrolled Type II diabetes;

4. Patients with paradoxical bronchospasm, narrow-angle glaucoma, symptomatic benignprostatic hyperplasia (benign prostatic hyperplasia patients who were stable ontreatment could have been considered), bladder-neck obstruction, severe renalimpairment, or urinary retention, or any other medical history, which, in theopinion of the investigator, would contraindicate the use of an anticholinergicagent;

5. Patients who have had hospitalized due to COPD or pneumonia within 8 weeks prior toscreening (Visit 1) or screening.

6. Patients who have had an acute (viral or bacterial) upper or lower respiratory tractinfection, sinusitis, pharyngitis or urinary tract infections within 4 weeks priorto screening (Visit 1) or screening.

7. Patients who have had a COPD exacerbation that required treatment with systemicsteroids, hospitalization or emergency treatment in the 8 weeks prior to screening (Visit 1).

8. Patients with conditions contraindicated for treatment with or having a history ofallergy or hypersensitivity to any of the following inhaled drugs, drugs of asimilar class or any component thereof: Anticholinergic/muscarinic receptorantagonist, Long- or short-acting β2-agonists, Sympathomimetic amines, Lactose/milkproteins, or any of the other excipients of the delivery system.

Other protocol-defined inclusion/exclusion criteria may apply.