A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Inclusion Criteria:

• Sign informed consent before the test and fully understand the test content, processand possible adverse reactions.

• Male and female subjects aged 40 to 80 years old (including the cut-off value).

• Body mass index (BMI) in the range of 18-30kg/m2 (including the critical value)

• Subjects have no pregnancy plan and voluntarily use effective contraception for atleast 1 month from screening to the last use of the study drug.

• Diagnosed as a COPD patient according to the The Global Initiative for ChronicObstructive Lung Disease (GOLD) 2024 criteria.

• Able to conduct acceptable and reproducible lung function tests.

• COPD clinical stability within the 4 weeks prior to screening visit (V1 visit) andbetween V1 visit and V2 visit.

• Smoking history ≥ 10 pack years.

Exclusion Criteria:

• History of life-threatening COPD, including admission to the intensive care unitand/or the need for intubation.

• Screening for COPD acute exacerbations that require systemic hormone therapy priorto the visit.

• Screening for hospitalization history due to COPD within the first 6 months.

• Use antibiotics for respiratory tract infections within 6 weeks prior to screeningor randomization visit.

• Chest computed tomography (CT) revealed clinically significant abnormalities andconcluded that the abnormalities were not caused by COPD.

• Previous lung resection or lung reduction surgery.

• Pulmonary rehabilitation treatment.

• Previously received TQC3721 treatment.

• Patients who received immunotherapy within the first 4 weeks of the screeningperiod.

• The patient has a history of diseases that are currently beyond their control.

• History or current evidence of cardiovascular disease with clinical significance.

• History of cured or untreated malignant tumors in any organ or system within thepast 5 years.

• Screening for clinically significant safety laboratory test outliers determined bythe researcher during the visit.

• Those who require oxygen therapy or intermittent oxygen therapy.

• Receive attenuated live vaccine within 28 days prior to randomization, inactivatedvaccine within 7 days, or study.

• Planned vaccine recipients during the period.

• Individuals who have participated in any drug or medical device clinical trialsprior to screening.

• Researchers believe that there are other situations that are not suitable forparticipation in the study.