SBP GROUP (01177): TQC2731 Injection "TSLP monoclonal antibody" Phase III registrational clinical trial for chronic rhinosinusitis with nasal polyps completes enrollment of all participants

SBP GROUP (01177) announces that the Phase III registrational clinical trial of TQC2731 Injection "TSLP monoclonal antibody," a National Class 1 innovative drug independently developed by the Group's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Chia Tai Tianqing), for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), has recently completed enrollment of all participants. TQC2731 is a humanized monoclonal antibody targeting TSLP. Thymic stromal lymphopoietin (TSLP) is an epithelial cell-derived cytokine produced in response to pro-inflammatory stimuli (such as infectious, allergic, and environmental stimuli) and trauma, and serves as an "upstream signal" that initiates inflammatory responses. Upon binding to the TSLP receptor (TSLPR) on the cell surface, TSLP can promote the activation of Th2-type inflammatory cells and the expression of various inflammatory cytokines such as IL-4, IL-5, and IL-13; meanwhile, TSLP can also enhance Th17 responses by affecting neutrophil function, participating in non-type 2 inflammatory responses. Therefore, blocking TSLP can inhibit the inflammatory initiation signal upstream of the inflammatory cascade, reduce the release of downstream inflammatory factors, and exert anti-inflammatory effects. CRSwNP is one of the main phenotypes of chronic rhinosinusitis (CRS), with a heavier clinical burden than chronic rhinosinusitis without nasal polyps (CRSsNP). Its core symptoms include persistent nasal congestion, loss of smell, and purulent nasal discharge, and it is often complicated by asthma, prone to recurrent episodes, and severely affects patients' quality of life. Intranasal corticosteroid-based pharmacotherapy combined with endoscopic surgery is currently the gold standard for CRSwNP treatment, but the postoperative recurrence rate still reaches 35%60%. CRS is classified by immune phenotype into type 2 and non-type 2 inflammation. Most currently marketed biologics focus on the type 2 inflammatory type and have poor efficacy in patients with non-type 2 inflammation, representing a significant unmet need. By antagonizing TSLP, TQC2731 is expected to simultaneously regulate both type 2 and non-type 2 inflammation, with differentiated development potential to cover a broader range of inflammatory phenotypes. In addition to CRSwNP, TQC2731 is conducting a Phase III registrational clinical trial for severe asthma. As the first domestic TSLP monoclonal antibody to enter Phase III clinical trials, TQC2731 is expected to provide new treatment options for more patients with type 2 and non-type 2 inflammation.