Clinical Study on TQH2722 Injection Combined With Background Therapy for Seasonal Allergic Rhinitis

Inclusion Criteria:

• Aged 18-75, with no gender restrictions.

• Diagnosed with seasonal allergic rhinitis.

• Positive allergen test result.

• The subjects have sufficient exposure to pollen during the pollen season.

• The subject's medical history indicates that the subject had poor control ofSeasonal Allergic Rhinitis (SAR) symptoms during the previous pollen season or thesubject was dissatisfied with the subjective symptom control.

• Screen for subjects who have a morning iTNSS score of ≥4 on the day of screening; atbaseline visit, have a morning iTNSS score of ≥4, and have an average rTNSS score of ≥4 over the past 6 days.

• Good compliance during screening/induction period.

• Subjects with comorbid asthma should have stable medication use before the screeningperiod and have their asthma condition assessed as stable by the investigator orspecialist.

• The subjects voluntarily joined this study, signed the informed consent form, andexhibited good compliance.

• The subjects and their partners agree to take effective contraceptive measuresthroughout the entire study period (from the signing of the Informed Consent Form (ICF) to 3 months after the last administration of the trial drug).

Exclusion Criteria:

• Any abnormal laboratory test value during the screening period or randomization.

• Any disease that researchers consider to be unstable and may affect the patient'ssafety throughout the entire study period, or affect the study results or theirinterpretation, or hinder the patient's ability to complete the entire studyprocess.

• Patients with active autoimmune diseases.

• Known or suspected immunosuppressants.

• Subjects with active malignant tumors or a history of malignant tumors.

• Screen for individuals with a history of active tuberculosis within the previous 12months.

• During the screening period, there is active hepatitis, or the presence of humanimmunodeficiency virus antibody (Anti-HIV) positivity, or syphilis treponemaantibody (Anti-TP) positivity.

• Screen for cases diagnosed with helminthic parasitic infections within the previous 6 months, who have not undergone standard treatment or have experienced ineffectivestandard treatment.

• Subjects who have received specific medications or undergone any nasal or sinussurgery within the specified timeframe.

• Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 daysbefore screening.

• Screen subjects who have used monoamine oxidase inhibitors within the previous 14days.

• Initiate allergen immunotherapy within 3 months prior to screening.

• Screen for individuals who have received attenuated live vaccines within theprevious 4 weeks or plan to receive attenuated live vaccines during the studyperiod.

• Screen for systemic Chinese herbal preparations used for the treatment of AR withshort- or medium-acting systemic glucocorticoids within 4 weeks, or screen forlong-acting Systemic Corticosteroids (SCS) received within the previous 6 weeks.

• Suffering from chronic active or acute infection within 2 weeks before screening orduring the screening and import period.

• Patients with concomitant asthma should be excluded if they meet any of thefollowing conditions: a. forced expiratory volume in one second (FEV1) ≤ 50% of thepredicted normal value; b. acute exacerbation of asthma within 90 days prior toscreening; c. currently using fluticasone propionate at a daily dose of >1000 μg/dayor equivalent doses of other inhaled corticosteroids; d. assessed by theinvestigator or specialist as having unstable asthma.

• The subject has a concomitant disease that renders them unable to complete thescreening period assessment or evaluate the primary efficacy endpoint.

• Suffering from malignant and benign tumors in the nasal cavity.

• Subjects with perennial allergic rhinitis (PAR) who are allergic to pet hair.

• Unable to use nasal corticosteroid sprays or antihistamines.

• Have a history of systemic allergy to any biological agents.

• Women who are pregnant or breastfeeding.

• Individuals who abuse alcohol, use drugs, and have known drug dependency.

• History of major organ transplantation or hematopoietic stem cell/bone marrowtransplantation.

• According to the researcher's judgment, there are any medical or psychiatricsymptoms that may put the subjects at risk, interfere with their participation inthe study, or interfere with the interpretation of the study results.

• The forced expiratory volume in one second (FEV1) of the subject is less than orequal to 50% of the predicted normal value.

• Other reasons why the researcher believes it is inappropriate to participate in thistrial.