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

• ✓. Understand the study and voluntarily sign the informed consent form.
• ✓. Age between 18 and 75 years (inclusive) at the time of informed consent signing, regardless of gender.
• ✓. 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)".
• ✓. 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.
• ✓. Concurrent presence of the following symptoms for ≥\[c9.1\]8 weeks prior to the screening/run-in period: a. nasal congestion; b. Any\[c10.1\] other symptom such as hyposmia/loss of smell or rhinorrhea
• ✓. 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%.
• ✓. Bilateral Nasal Polyp Score (NPS) ≥5 (maximum score 8) with ≥2 points per nostril, as assessed by nasal endoscopy during screening and before randomization.
• ✓. Nasal Congestion Score (NCS) ≥2 at the screening visit and before randomization(weekly average score).\[c11.1\]\[11.2\]

Exclusion criteria