[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,67,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100621566","phase-3-a-phase-iii-study-of-cm326-in-subjects-with-moderate-to-severe-asthma-100621566",false,"NCT07372287","A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma","A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma","Inclusion Criteria:\n\n1. Understand the study and voluntarily sign the informed consent form.\n2. Age ≥18 and ≤80 years old, male or female, weight ≥40 kg.\n3. The subject has been diagnosed with asthma for at least 1 year.\n4. Pre-bronchodilator FEV1 measured ≤80% of the normal predicted value.\n5. A positive bronchodilation test within 24 months before informed consent or at screening.\n6. The subject has received medium-to-high dose ICS combined with at least one control drug, such as LABA, LAMA, LTRA, Oral corticosteroids, theophylline, for at least 3 months before signing the informed consent, and maintained stable treatment regimen and dosage for at least 1 month before signing the informed consent.\n7. Asthma Control Questionnaire-5 (ACQ-6) score ≥1.5.\n8. Subjects must have experienced at least one severe asthma exacerbation event within 12 months before informed consent, and have not experienced a severe asthma exacerbation event within 30 days before informed consent.\n9. ≥ 80% compliance with usual asthma controller therapy in subjects during the screening phase\n10. Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Chronic obstructive pulmonary disease (COPD) without asthma or other lung disease that may impair lung function, as judged by the investigator.\n2. Have systemic diseases other than asthma that result in an elevated peripheral blood eosinophil count or other diseases such as helminth parasitic infections for which standard treatment is not received or does not respond.\n3. Prior autoimmune disease or inflammatory treatment with biologic agents\u002Fsystemic immunosuppressive agents within 8 weeks or 5 half-lives (whichever is longer) prior to informed consent.\n4. Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection, even if the infection has resolved; or the presence of unusual frequent, recurrent, or prolonged infections.\n5. History of malignancy.\n6. The presence of any severe and\u002For uncontrolled medical condition that in the judgment of the investigator may affect the evaluation of the drug, including but not limited to: severe neurological disease, history of severe mental disorder, diabetes mellitus poorly controlled by intensive treatment.\n7. Active infection or acute infection requiring systemic anti-infective therapy from 4 weeks before enrollment to the time of randomization.\n8. A history of severe cardiovascular disease or clinically significant abnormalities identified by 12-lead electrocardiogram (ECG) during the screening phase.\n9. Major surgery within 8 weeks prior to informed consent requiring general anesthesia or hospitalization for \\> 1 day .\n10. Received biological agents with the same therapeutic purpose within 4 months or 5 half-lives (whichever is longer) before signing the informed consent.\n11. Have been enrolled in a clinical trial of any drug or medical device within 3 months before signing informed consent, or are within the follow-up period of a clinical study or the five half-lives of the trial drug (whichever is longer) before signing informed consent.\n12. Received immune globulin or blood products within 30 days before informed consent.\n13. Subjects treated with systemic corticosteroids other than for the treatment of asthma from 8 weeks before signing the informed consent to the date of randomization.\n14. Received live or attenuated vaccine within 3 months before informed consent.\n15. Initiation of desensitization therapy within 3 months before informed consent.\n16. Underwent bronchial thermoplasty within 12 months before informed consent.\n17. Current smokers or former smokers who quit smoking less than 6 months or former smokers who quit smoking more than 6 months with a smoking history of more than 10 pack-years.\n18. At screening, any infectious disease screening indicator meets one of the following criteria: a. HBsAg positive b. HBsAg negative , HBcAb positive, HBV DNA exceed the lower limit of quantitation (LLOQ) or 1000 copies\u002FmL (500 IU\u002FmL)(whichever is lower) c. HCV antibody positive, HCV RNA exceed the LLOQ or 1000 copies\u002FmL(whichever is lowerd). d.HIV antibody positive. e.Treponema pallidum antibody positive\n19. At screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2 × upper limit of normal (ULN), or serum creatinine (Cr) \\> 1.5 × ULN.\n20. Allergy or intolerance to components of CM326 injection or placebo or history of severe drug allergy or anaphylactic shock.\n21. Subjects who have used heavy alcohol within 3 months before screening.\n22. History of drug abuse within 5 years before signing informed consent.\n23. Females with a positive pregnancy test, pregnant females, or lactating females.\n24. The investigator considers that there are any conditions that may prevent the subject from completing the study.","ALL","18 Years","80 Years",{"count":20,"type":21},230,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma.\n\nThe study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up period.",[27],"Moderate to Severe Asthma","RECRUITING","2026-04-27",{"date":31,"type":32},"2026-04-28","ACTUAL",{"date":34,"type":32},"2026-01-23",{"date":36,"type":21},"2029-03-31",{"name":38,"class":39},"CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100636003","phase-1-a-comparative-pharmacokinetic-study-of-cm326-in-healthy-subjects-100636003","NCT07560033","A Comparative Pharmacokinetic Study of CM326 in Healthy Subjects","A Randomized, Open-Label, Parallel-Controlled Phase I Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of a Single Subcutaneous Injection of CM326 Via Different Delivery Devices in Healthy Subjects","Inclusion Criteria:\n\n1. Participants \\[c1.1\\]must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;\n2. Healthy male participants aged 18 to 55 years;\n3. Body weight between 55.0 and 85.0 kg, and body mass index between 19.0 and 26.0 kg\u002Fm²;\n4. Physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, and other examination results are normal, or abnormal but without clinical significance;\n5. Participants and their partners agree to use effective and reliable contraceptive methods from signing the ICF until 3 months after dosing;\n6. Participants are able to communicate well with the investigator, and to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. History of chronic diseases or severe diseases involving the circulatory system, blood or hematopoietic system, respiratory system, endocrine system, urinary system, digestive system, immune system, psychiatric or nervous system, reproductive system, etc.;\n2. Presence or suspicion of any active viral, bacterial, fungal, or parasitic infection within 14 days before dosing;\n3. Participants who have undergone major surgery within 3 months before screening, or who plan to undergo major surgery during the study period;\n4. History of allergies to drugs, food, etc., or Participants who may be allergic to the study drug or its components in the Investigator's judgment;\n5. Positive result for any of the following: hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, human immunodeficiency virus antigen\u002Fantibody;\n6. History of drug abuse, or use of illicit drugs within 3 months before screening, or habitual use of any psychotropic drugs (including herbal medicines), or a positive urine drug screen;\n7. Blood loss or blood donation of more than 200 mL within 3 months before screening;\n8. Intolerance to subcutaneous injection, or presence of abdominal scars that affect subcutaneous administration, and any skin abnormalities and\u002For tattoos that may affect the safety assessment of the injection site;\n9. Use of any prescription drugs, over-the-counter drugs, herbal medicines or vitamin and dietary supplements within 14 days or 5 half-lives (whichever is longer) before dosing;\n10. Use of any marketed or investigational biological products within 6 months or 5 half-lives (whichever is longer) before dosing;\n11. Participants who have previously used CM326 or drugs targeting TSLP;\n12. Vaccination within 4 weeks before screening, or plan to receive such vaccines during the study;\n13. Participation in any clinical trial within 3 months before screening;\n14. Average daily smoking of more than 5 cigarettes within 3 months before screening, or unwilling to avoid using any tobacco products during the study;\n15. Regular alcohol consumption within 3 months before screening, defined as weekly alcohol consumption exceeding 14 units (1 unit = 360 mL of 5% alcohol beer or 45 mL of 40% alcohol spirits or 150 mL of 12% alcohol wine), or inability to stop alcohol intake during the study, or a positive blood alcohol test;\n16. Regular consumption of excessive amounts of tea, coffee, and\u002For caffeinated beverages within 3 months before screening;\n17. Participants who have special dietary requirements and are unable to comply with the standardized diet;\n18. History of needle phobia or hemophobia, or d difficulty with venipuncture or unable to tolerate venous puncture;\n19. Participants who, in the Investigator's judgment, may be unable to complete the study for other reasons or are considered unsuitable for enrollment.",true,"MALE","55 Years",{"count":52,"type":21},192,[54],"PHASE1","This is a randomized, open-label, parallel-controlled study to compare the PK, safety, and immunogenicity of CM326 administered via different delivery devices in healthy subjects.",[57],"Healthy Subjects","NOT_YET_RECRUITING","2026-04-23",{"date":61,"type":32},"2026-04-30",{"date":63,"type":21},"2026-04-20",{"date":65,"type":21},"2026-12-31",{"name":38,"class":39},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":40},"100579903","phase-1-the-safety-tolerability-and-pharmacokinetics-of-of-syh9017-in-chinese-participants-with-overweight-and-obesity-100579903","NCT06830343","The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic of SYH9017 in Chinese Participants With Overweight and Obesity Following Single and Multiple Doses","Inclusion Criteria:\n\n1. Chinese male or female adult participants aged 18-60 years (inclusive) with overweight or obesity, with no less than one-third of the participants of either gender;\n2. SAD phase: Body Mass Index (BMI) = weight (kg)\u002Fheight\\^2 , with BMI in the range of 24.0-28.0 kg\u002Fm\\^2 (inclusive); MAD phase: Weight ≥70 kg (for males) or ≥60 kg (for females), and BMI = weight (kg)\u002Fheight\\^2 , with BMI ≥28.0 kg\u002Fm\\^2;\n3. Weight change \\\u003C5% in the 3 months prior to screening (can be based on self-report); calculated as: (weight 12 weeks before screening - weight at screening) \u002F weight at screening \\* 100%;\n4. Vital signs, physical examination, 12-lead electrocardiogram, chest X-ray (anteroposterior view), abdominal color Doppler ultrasound, clinical laboratory tests (complete blood count, urinalysis, blood biochemistry, glycated hemoglobin, coagulation function, infectious disease screening, thyroid function, calcitonin, etc.) show normal results or abnormal results deemed not clinically significant by the investigator;\n5. Able to read and understand the written informed consent related to the study information, fully aware of the study content, process, and possible adverse reactions, voluntarily sign the informed consent form before the trial, and ensure that they will personally participate in any procedures; Participants and their partners agree to use effective non-hormonal contraception methods (such as condoms, inert intrauterine devices, female barrier methods \\[cervical cap or diaphragm with spermicide\\], vaginal contraceptive rings, etc.) from the time of signing the informed consent form until 6 months after the last dose, or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.); Male participants do not plan to donate sperm from the time of signing the informed consent form until 6 months after the last dose, and female participants do not plan to donate eggs from the time of signing the informed consent form until 6 months after the last dose.\n\nExclusion Criteria:\n\n1. A history of severe drug or food allergies, or any participant who is judged by the investigator to potentially be allergic to the investigational drug;\n2. A history of significant diseases involving the pancreas, liver, kidneys, gastrointestinal tract, skin, cardiovascular system, respiratory system, hematological system, central nervous system, or other conditions that may endanger the safety of participants or affect the absorption, metabolism, or excretion of the study drug, and are deemed unsuitable for inclusion by the investigator;\n3. A history of malignancy (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix), psychiatric disorders (such as depression, schizophrenia, bipolar disorder, or a history of suicidal ideation or behavior), epilepsy, acute biliary disease, or confirmed acute or chronic pancreatitis; participants judged by the investigator to be unsuitable for participation in this clinical study;\n4. Diagnosed with diabetes, thyroid dysfunction (abnormal TSH, FT3, or FT4 levels), Cushing's syndrome, polycystic ovary syndrome, a history of glucagonoma or pheochromocytoma, or other endocrine diseases that may affect glucose metabolism, or has experienced ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia;\n5. A personal or family history of medullary thyroid carcinoma (MTC) or a history of multiple endocrine neoplasia type 2 (MEN2).\n6. Any one of the following criteria is met:\n\n   i. Participants with one or more abnormal vital signs: body temperature \\\u003C35.5°C or \\>37.2°C, pulse rate \\\u003C50 beats per minute or \\>100 beats per minute, systolic blood pressure ≥160 mmHg or \\\u003C90 mmHg, diastolic blood pressure ≥100 mmHg or \\\u003C60 mmHg. A single retest is allowed, and participants with abnormalities in both tests will be excluded; ii. Any of the following laboratory abnormalities: a) Fasting plasma glucose ≥7.0 mmol\u002FL or fasting plasma glucose \\\u003C3.9 mmol\u002FL or HbA1c level \\>6.5%; b) AST or ALT \\>2 times the upper limit of normal (ULN), total bilirubin \\>1.5 times ULN, deemed clinically significant by the investigator; c) Estimated glomerular filtration rate (eGFR) \\\u003C90 mL\u002Fmin\u002F1.73m²; d) Serum amylase or lipase \\>3 times ULN; e) Blood low-density lipoprotein cholesterol (LDL-C) ≥4.40 mmol\u002FL; f) Triglycerides (TG) ≥5.65 mmol\u002FL.\n7. During the multiple-dose phase: Use of any approved or unapproved drugs or products that may affect body weight within 6 months prior to screening, including but not limited to orlistat, phentermine-topiramate, naltrexone-bupropion, systemic steroid medications (administered intravenously, orally, or intra-articularly), antidepressants (selective serotonin reuptake inhibitors (SSRIs), noradrenaline reuptake inhibitors (SNRIs), tricyclics, tetracyclics, etc.), psychotropic medications or sedative drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproate, valproate derivatives, lithium salts), etc.; or use of traditional Chinese medicines, health supplements, meal replacements, or antibiotic drugs or probiotic preparations that influence gut microbiota and thereby affect body weight; or having undergone bariatric surgery within 6 months prior to screening;\n8. Use of glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1 analogs (such as liraglutide, dulaglutide, lixisenatide, exenatide, albiglutide, benraliptide, polyethylene glycol loxenatide, etc.) or any dipeptidyl peptidase-4 (DPP-4) inhibitors or glucose-dependent insulinotropic polypeptide (GIP) receptor agonists within 6 months prior to signing the informed consent form.\n9. Use of any prescription medications, over-the-counter medications, traditional Chinese patent medicines, herbal remedies, vitamin dietary supplements, or health products within 4 weeks prior to signing the informed consent form;\n10. Habitual intake of or consumption of excessive amounts of xanthine or caffeine-containing foods, beverages, or other substances that may affect drug absorption, distribution, metabolism, or excretion within 1 month prior to screening or within 72 hours before using the investigational drug. Examples include: coffee (more than 1100 mL per day), tea (more than 2200 mL per day), cola (more than 2200 mL per day), energy drinks (more than 1100 mL per day), chocolate (more than 510 g per day);\n11. Undergone surgery (including cosmetic, dental, and oral surgeries) within 6 months prior to screening or planned during the trial period, or plans to engage in vigorous physical activity (including contact sports or collision sports) during the trial period;\n12. A history of drug abuse or a positive drug screening test within 1 year prior to signing the informed consent form;\n13. Loss of blood or donation of more than 400 mL of blood within 3 months prior to signing the informed consent form, or receipt of blood transfusions or use of blood products;\n14. Consumption of more than 14 units of alcohol per week (1 unit = 285 mL of beer; 25 mL of spirits; 150 mL of wine) within 3 months prior to signing the informed consent form, or consumption of any alcohol-containing products within 48 hours before using the investigational drug; positive baseline alcohol test (\\>0 mg\u002F100 mL) or inability to abstain from alcohol during the trial period;\n15. Smoking ≥5 cigarettes daily within 6 months prior to signing the informed consent form, smoking within 48 hours before using the investigational drug, or inability to cease the use of any tobacco products during the trial period;\n16. Participation in any clinical trial involving investigational drugs or medical devices within 3 months prior to signing the informed consent form;\n17. Pregnant and\u002For breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening and before dosing;\n18. A history of vasovagal syncope or hemophobia, or difficulty with venipuncture for any reason, making it intolerable;\n19. Difficulty with subcutaneous injection administration;\n20. Any other factors deemed by the investigator to make the participant unsuitable for participation in the trial.","60 Years",{"count":76,"type":21},66,[54],"This is a randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity.",[80],"Overweight or Obesity",[82],"overweight or obesity","2026-04-03",{"date":85,"type":32},"2026-04-06",{"date":87,"type":32},"2025-02-27",{"date":89,"type":21},"2026-10-01",{"name":38,"class":39},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100625255","phase-3-a-randomized-double-blind-placebo-controlled-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-cm326-in-participants-with-chronic-rhinosinusitis-with-nasal-polyposis-100625255","NCT07420257","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis","Inclusion Criteria:\n\n1. Understand the study and voluntarily sign the informed consent form.\n2. Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.\n3. Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) meeting the diagnostic criteria of the \"Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2024)\".\n4. Meet at least 1 of the following 4 items: a. Received SCS treatment for at least 3 consecutive days within 2 years prior to screening; b. Received at least one long-acting SCS (such as triamcinolone acetonide injection) within 2 years prior to screening; c. Had \\[c8.1\\]contraindications to SCS treatment or intolerance to SCS treatment; d. Received nasal polyp surgery more than 6 months prior to screening.\n5. Concurrent presence of the following symptoms for ≥\\[c9.1\\]8 weeks prior to the screening\u002Frun-in period: a. nasal congestion; b. Any\\[c10.1\\] other symptom such as hyposmia\u002Floss of smell or rhinorrhea\n6. Stable dose of intranasal corticosteroids (INCS) for \\>4 weeks prior to screening (participants using non-mometasone furoate nasal spray \\[MFNS\\] products must agree to switch to Mometasone Furoate Nasal Spray (MFNS) during the study). The evaluation during the lead-in period showed that the medication adherence to intranasal mometasone furoate nasal spray (MFNS) was greater than 70%.\n7. Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and before randomization.\n8. Nasal Congestion Score (NCS) ≥2 at the screening visit and before randomization(weekly average score).\\[c11.1\\]\\[11.2\\]\n9. 22-item Sino-Nasal Outcome Test (SNOT-22) score ≥30 at screening and before randomization.\n10. Eligible participants of childbearing potential (males and females) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence, etc.) with their partners during the trial and for 3 months after the last dose; Females of childbearing potential must be non-lactating, have a negative blood pregnancy test at screening, and have a negative blood or urine pregnancy test before randomization.\n\nExclusion Criteria:\n\n1. Presence of nasal conditions affecting NPS evaluation, including but not limited to: a. Antrochoanal polyps; b. Nasal septum perforation or severe nasal septum deviation occluding at least one nostril; c. Nasal surgery that alters the structure of the lateral nasal wall precluding completion of the NPS assessment.\n2. Clinically significant comorbidities other than asthma that may affect the efficacy assessment or interfere with the interpretation of the efficacy assessment results, including but not limited to: a. Allergic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), allergic bronchopulmonary mycosis, and eosinophilic esophagitis; b. Bronchiectasis, pulmonary fibrosis, cystic fibrosis; c. Primary ciliary dyskinesia, Young's syndrome, Kartagner's syndrome, or other ciliary dyskinesia syndromes; d. Acute sinusitis, nasal infection, or upper respiratory tract infection at the time of the screening visit or within 2 weeks prior to the screening visit; e. Persistent rhinitis medicamentosa; f. Imaging suspected or confirmed fungal sinusitis; g. Malignant or benign tumors of the nasal cavity or paranasal sinuses.\n3. Uncontrolled epistaxis within 2 months prior to screening;\n4. Concomitant major chronic diseases that are uncontrolled and that, in the opinion of the investigator, may increase the safety risk of the participant's participation in this study;\n5. Participants with other concomitant active or clinically significant respiratory diseases that may significantly affect the study, as judged by the investigator;\n6. Participants with cardiovascular disease, and whose participation in this trial may affect the safety of the participants or the analysis of the study results at the discretion of the investigator.\n7. Active malignancy of any type or history of malignancy;\n8. Infection requiring systemic antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal treatment within 14 days prior to screening; Diagnosed with helminthic parasitic infection within 6 months prior to screening and untreated or refractory to standard therapy;\n9. History of active pulmonary tuberculosis within 12 months prior to screening, or old tuberculosis with high risk of recurrence as assessed by the investigator;\n10. Known or suspected history of immunosuppression, immune dysfunction or immune dysregulation, including but not limited to invasive opportunistic infections even if the infection has resolved, history of splenectomy, primary immunodeficiency, etc.; or unusually frequent, recurrent, or prolonged infections as judged by the investigator;\n11. Participants with comorbid asthma who have any of the following conditions: a. FEV1 ≤ 50% of the predicted normal value during the screening period and before baseline; b. Asthma exacerbation within 90 days prior to screening; c. Participants who are currently using inhaled corticosteroids at a daily dose higher than 1000 μg of fluticasone or equivalent, or who have started inhaled corticosteroids within 4 weeks prior to screening;\n12. Nasal surgery within 6 months prior to screening;\n13. Received medium- or short-acting SCS (including oral, intravenous, or intramuscular glucocorticoids) or traditional Chinese medicine (including systemic and topical traditional Chinese medicine preparations) for the treatment of chronic sinusitis within 4 weeks prior to screening, or received long-acting SCS (such as triamcinolone acetonide injection) within 6 weeks prior to screening, or plan to receive the above drugs during the study; Use of glucocorticoid-eluting intranasal stents within 6 months prior to screening;\n14. Patients who have received treatment with other biological agents other than anti-TSLP monoclonal antibodies, including but not limited to IL-4Rα monoclonal antibodies and anti-IgE monoclonal antibodies, within 8 weeks or 5 half-lives (whichever is longer) prior to screening;\n15. Previous treatment with anti-TSLP monoclonal antibody;\n16. Received systemic immunosuppressant therapy within 8 weeks or 5 half-lives (whichever is longer) prior to screening;\n17. Treatment with leukotriene receptor antagonists within 4 weeks before baseline;\n18. Regular use of decongestants (topical or systemic) within 4 weeks prior to screening, except for short-term use for endoscopy;\n19. Initiation of allergen-specific immunotherapy (desensitization therapy) within 3 months prior to baseline, or planned initiation of such therapy during the study period;\n20. Treatment with immunoglobulin or blood products within 30 days prior to screening;\n21. Any of the following infectious disease screening indicators meet the following criteria at screening: a. HBsAg positive or HBcAb positive and HBV-DNA positive; Patients who have received antiviral therapy in the past need to be excluded even if HBV-DNA is negative; b. HCV antibody positive and HCV-RNA positive. Patients who have received previous treatment for hepatitis C should still be excluded even if HCV-RNA is negative; c. Positive Treponema pallidum antibody test (if the Treponema pallidum particle agglutination test is positive, RPR or TRUST for syphilis is required. If the RPR or TRUST test is negative and the investigator judges that the participant has been infected with syphilis in the past but has been cured, he or she is eligible for inclusion); d. Human immunodeficiency virus antibody (Anti-HIV) positive.\n22. Clinically\\[c12.1\\] significant laboratory abnormalities that, in the opinion of the investigator, pose a risk to or affect the participant's participation in the study; Or meet any of the following criteria: a. Glutamate aminotransferase or aspartate aminotransferase \\>2.5×ULN; b. Total bilirubin and\u002For direct bilirubin \\>2×ULN; c. Absolute neutrophil count \\\u003C1.5×10\\^9\u002FL; d. Serum creatinine \\>1.5×ULN.\n23. Clinically significant abnormal findings found during the screening period, including physical examination, vital signs, 12-lead ECG, etc., which in the opinion of the investigator will pose a risk or affect the participant's participation in the study;\n24. Hypersensitivity to MFNS or CM326; History of severe systemic allergy to any biologic agent (except local injection site reaction);\n25. History of drug abuse, narcotics, and\u002For excessive alcohol consumption within 6 months prior to screening, as assessed by the investigator;\n26. Current smokers or participants with a smoking history of ≥10 pack-years;\n27. Vaccination with a live attenuated vaccine within 30 days prior to randomization or planned vaccination with a live attenuated vaccine during the study;\n28. Use of any other clinical study drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to screening; Or still participating in or planning to participate in other clinical trials;\n29. As assessed by the investigator, the participant's poor compliance with this study (such as a clear history of mental disorder) makes it impossible to complete the study;\n30. Other medical or non-medical conditions that, in the opinion of the investigator, make the participant unsuitable for participation in this study.","75 Years",{"count":99,"type":21},212,[24],"This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and I immumogenicity\\[c2.1\\] of CM326 in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).The study consists of four periods, including an up to 4-week screening\u002Frun-in period, a 24-week double-blind randomized treatment period, a 28-week open-label treatment period, and an 8-week safety follow-up period.",[103],"Chronic Rhinosinusitis With Nasal Polyps",[105],"CM326，anti-TSLP biologics, Chronic rhinosinusitis with nasal polyps，allergy","2026-02-12",{"date":108,"type":32},"2026-02-19",{"date":110,"type":21},"2026-02-28",{"date":112,"type":21},"2028-10-30",{"name":38,"class":39},""]