Long-term Safety and Efficacy of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps

Inclusion Criteria:

1. Inclusion Criteria of Part A

• Sign informed consent before the test to fully understand the purpose, processand possible adverse reactions of the test;

• Age 18-75 years old (including the threshold), male or female;

• Enroll in the clinical study of TQH2722 for chronic sinusitis with or withoutnasal polyps (study number TQH2722-II-02) and meet the following criteria "a"or "b" :

1. Subjects completed prescribed treatment as required and completed Part Aend of study (EOS) visit;
2. The subjects withdrew early due to poor compliance or other objectivereasons other than TQH2722-related AE, and completed the early exitinterview according to the plan, and the influencing factors that led tothe subjects' early termination of the main study treatment havedisappeared/no longer affected the subjects' participation in thecontinuation study as assessed by the investigators and sponsors. Note: If protocol window period requirements are met, examination results fromsubject's main study EOS/ early exit visit may be used as screening/baselineexamination for this study.

• Subjects had used a more stable dose of nasal glucocorticoids (INCS) for morethan 4 weeks prior to screening (for subjects who had used other INCS prior toscreening than intranasal Mometasone furoate nasal spray (MFNS), subjects werewilling to switch to MFNS during the study);

• Subjects agree not to have a family plan for 6 months from the date of signingthe informed consent to the last dose, and must use effective non-drugcontraception with their sexual partners of childbearing age.

2. Inclusion Criteria of Part B

• Sign informed consent before the test to fully understand the purpose, processand possible adverse reactions of the test;

• Age 18-75 years old (including the threshold), male or female;

• Enroll in the clinical study of TQH2722 for chronic sinusitis with or withoutnasal polyps (study number TQH2722-II-02) and meet the following criteria "a"or "b" :

1. Subjects completed prescribed treatment as required and completed Part BEOS visit;
2. The subjects withdrew early due to poor compliance or other objectivereasons other than TQH2722-related AE, and completed the early exitinterview according to the plan, and the influencing factors that led tothe subjects' early termination of the main study treatment havedisappeared/no longer affected the subjects' participation in thecontinuation study as assessed by the investigators and sponsors.

Note: If protocol window period requirements are met, examination results from subject's main study EOS/ early exit visit may be used as screening/baseline examination for this study.

• Subjects had used a more stable dose of nasal glucocorticoids (INCS) for more than 4weeks prior to screening (for subjects who had used other INCS prior to screeningthan intranasal Mometasone furoate nasal spray (MFNS), subjects were willing toswitch to MFNS during the study);

• Subjects agree not to have a family plan for 6 months from the date of signing theinformed consent to the last dose, and must use effective non-drug contraceptionwith their sexual partners of childbearing age.

Exclusion Criteria:

• In the main study (TQH2722-II-02), a TQH2722-related SAE occurred or TQH2722-relatedAE led to the discontinuation of TQH2722 therapy, and after discussion between theinvestigator and sponsor, the subject was deemed unsuitable for continuation ofTQH2722 therapy.

• The subjects had poor compliance in the main study, and the researchers judged thatthey could not complete the continuing study.

• During the main study (TQH2722-II-02), any severe progression or poorly controlledconcomitant disease (such as asthma exacerbation requiring adjustment of backgroundmedication) is identified and the subject is deemed unfit to participate by theprincipal investigator;

• Any of the following laboratory test values are abnormal during the screeningperiod:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 upperlimit of normal (ULN);

2. Total bilirubin > 2 x ULN (except indirect bilirubin elevation secondary toGilbert syndrome);

3. Creatinine > 1.5×ULN;

• Any medical condition, including but not limited to cardiovascular,gastrointestinal, liver, kidney, neurological, musculoskeletal, infectious,endocrine, metabolic, hematological, psychiatric, or major limb disorders, that theinvestigator believes is unstable and may affect the patient's safety throughout thestudy period, or affect the study results or their interpretation, or interfere withthe patient's ability to complete the entire study process.For example, but notlimited to: ischemic heart disease, left ventricular failure, arrhythmia,uncontrolled hypertension, uncontrolled hyperglycemia, cerebrovascular disease,etc.;

• Patients with active autoimmune diseases (including, but not limited to, Hashimotothyroiditis, Graves' disease, inflammatory bowel disease, primary biliarycholangitis, systemic lupus erythematosus, multiple sclerosis and otherneuroinflammatory diseases, psoriasis vulgaris, rheumatoid arthritis);

• Known or suspected immunosuppressed individuals, including but not limited to ahistory of invasive opportunistic infections (e.g., histoplasmosis, listeriosis,coccidioidomycosis, pulmonary cyst disease, aspergillosis), even if the infectionhas resolved;

• Subjects with active malignant tumors or a history of malignant tumors:Patients withbasal cell carcinoma, skin localized squamous cell carcinoma, or cervical carcinomain situ who had completed curative treatment for at least 12 months prior to visit 1could be enrolled in this study; patients with other malignancies could be enrolledif they had completed curative treatment for at least 5 years prior to visit 1;

• A history of active pulmonary tuberculosis within 12 months prior to screening;

• Active hepatitis was present at the screening stage, either hepatitis B surfaceantigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and Hepatitis BVirus-DNA positive, or Hepatitis C Virus (HCV) antibody positive and HCV-RNApositive; or human immunodeficiency virus (Anti-HIV) positive, or treponema pallidumantibody (Anti-TP) positive (if the treponema pallidum serological test is positive,then further non-treponema pallidum serological test is performed, the latter isnegative and the investigator determines that patients who have been infected withsyphilis in the past but have been cured are eligible for inclusion);

• Diagnosis of helminthic infection within 6 months prior to the screening period,failure to receive standard treatment or failure to respond to standard treatment;

• Subjects who received the following treatments:

1. Had sinus surgery or nasal sinus surgery within 6 months prior to screening (visit 1).

2. Received monoclonal antibody therapy within 8 weeks or 5 half-lives prior toscreening (whichever is longer);

3. Received immunosuppressive therapy (including but not limited tocyclophosphamide, cyclosporine, interferon gamma, azathioprine, methotrexate,mycophenolate and tacrolimus) within 8 weeks or 5 half-lives prior toscreening, whichever is longer;

4. Use of other non-biological agents within 8 weeks or 5 half-lives (whichever islonger) prior to screening;

5. Intravenous immunoglobulin (IVIG) therapy and/or plasma exchange within 30 daysprior to screening visit (Visit 1);

6. Subjects treated with leukotriene antagonists/modulators prior to screening (subjects treated with stable doses of leukotriene modulators for ≥30 daysprior to screening can be enrolled);

7. Start allergen immunotherapy within 3 months prior to screening, or plan tostart such therapy during the study period or plan to change the therapeuticdose during the study period;

8. Have received live attenuated vaccine within 4 weeks prior to screening or planto receive live attenuated vaccine during the study period;

9. Chronic active or acute infection requiring systemic treatment withantibiotics, antivirals, antiparasites, antivirals, or antifungals during the 4weeks prior to screening, or a viral disease that may not have receivedantiviral treatment during the 4 weeks prior to screening;(Screening visits canbe performed after the patient recovers from infection, but the systemicantibiotic washout period needs to be greater than 2 weeks).

• Patients with asthma should be excluded if: a. forced expiratory volume in the firstsecond (FEV1) ≤ 50% of the expected normal value, or b.Acute exacerbation of asthmawithin 90 days prior to screening requiring hospitalization (>24 hours), or c.Areusing a daily dose of fluticasone or equivalent inhaled glucocorticoids (ICS)greater than 1000mcg;

• Subjects with asthma were initiated with inhaled corticosteroids within 4 weeksprior to the screening/induction period (for subjects who could receive a stabledose for at least 4 weeks prior to screening and whose assessed dose could bemaintained throughout the study period, inhaled corticosteroids could be fluticasonepropionate at a dose ≤1000μg or equivalent doses of other inhaled corticosteroids).

• Subjects have concomitant medical conditions that prevent them from completing thescreening period assessment or evaluating the primary efficacy endpoint, such as:

1. A deviated nasal septum leads to obstruction of at least one nostril

2. Persistent drug rhinitis;

3. The diagnosis was eosinophilic granulomatous vasculitis (Churg-Strausssyndrome), granulomatous polyvasculitis (Wegener's granuloma), Young'ssyndrome, Kartagener syndrome or other ciliary dyskinesia syndrome, cysticfibrosis;

4. Suspected or confirmed fungal rhinosinusitis on imaging;

• Subjects with nasal malignancies and benign tumors (e.g., papilloma, hemangioma,etc.);

• Subjects who are unable to use MFNS or are allergic or intolerant to Mometasonefuroate nasal spray;

• Subjects with a history of systemic allergy to any biological agent (except localinjection site reactions);

• Pregnant or lactating women;

• Alcohol, drug and known drug dependence;

• The subjects had poor compliance in the study and could not complete the study asjudged by the researcher;

• Any medical or psychiatric condition that, in the judgment of the investigator orsponsor medical reviewer, puts the subject at risk, interferes with participation inthe study, or interferes with the interpretation of the study results.