China Biopharmaceutical (01177): TQC2731 injection “TSLP monoclonal antibody” phase III clinical registration for chronic sinusitis with nasal polyps completed the enrollment of all participants

Zhitong Finance App News, China Biopharmaceutical (01177) announced that the Phase III registered clinical trial of the national Class 1 innovative drug TQC2731 injection “TSLP monoclonal antibody” independently developed by the group subsidiary Zhengda Tianqing Pharmaceutical Group Co., Ltd. for maintenance treatment of chronic sinusitis with nasal polyps (CrSwnP) has recently completed the enrollment of all participants.

TQC2731 is a humanized monoclonal antibody targeting TSLP. Thymic stromal lymphopoietin (TSLP) is a cytokine derived from epithelial cells. It is produced in pro-inflammatory stimuli (such as infectious, allergic, and environmental stimuli) and traumatic responses, and is an “upstream signal” that initiates an inflammatory response. When TSLP binds to TSLP receptors (TSLPR) on the cell surface, it can promote the activation of Th2 inflammatory cells and the expression of various inflammatory cytokines such as IL-4, IL-5, and IL-13; at the same time, tSLP can also enhance Th17 response by affecting neutrophil function and participate in non-type 2 inflammatory responses. Therefore, blocking TSLP can inhibit inflammatory initiation signals upstream of the inflammatory cascade response, reduce the release of downstream inflammatory factors, and exert anti-inflammatory effects.

CrSwnP is one of the main phenotypes of chronic sinusitis (CRS). It has a heavier clinical burden than chronic sinusitis without nasal polyps (crSSNP). It has persistent nasal congestion, loss of smell, and pus as the core symptoms. It is often associated with asthma. It is prone to recurrent episodes and seriously affects patients' quality of life. Nasal glucocorticoid as the core drug treatment combined with endoscopic surgery is currently the gold standard for CRSwnP treatment, but the recurrence rate after surgery still reaches 35% to 60%. CRS is divided into type 2 and non-type 2 inflammation according to the immunophenotype. Most of the biologics currently on the market focus on type 2 inflammation types. The curative effect on patients with non-type 2 inflammation is poor, and there are clearly no requirements. By antagonizing TSLP, TQC2731 is expected to simultaneously regulate type 2 and non-type 2 inflammation, and has the potential for differentiated development covering a wider range of inflammatory phenotypes.

In addition to crSWnP, TQC2731 is undergoing a phase III registered clinical trial for severe asthma. As the first domestically produced 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.