SBP GROUP (01177): New Drug Application for TQH2722 Injection "IL-4R monoclonal antibody" accepted

SBP GROUP (01177) announced that the New Drug Application (NDA) for TQH2722 Injection "IL-4R monoclonal antibody", a National Class 1 innovative drug independently developed by the Company's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Chia Tai Tianqing), has been submitted to and accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults whose disease is inadequately controlled with topical therapies or who are not suitable for topical therapies. TQH2722 is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4R). By specifically binding to IL-4R, it simultaneously inhibits the activation of signaling pathways mediated by IL-4 and IL-13, thereby blocking the type 2 inflammation pathway from upstream and reducing type 2 inflammation-related pathological responses. The acceptance of this NDA is based on positive clinical results from the TQH2722-III-01 study. TQH2722-III-01 is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating TQH2722 in the treatment of moderate-to-severe atopic dermatitis, enrolling a total of 500 patients. The co-primary endpoints the proportion of patients achieving at least 75% improvement from baseline in the Eczema Area and Severity Index score at Week 16 (EASI 75) response rate and the Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0/1) response rate were both met, and multiple secondary endpoints also achieved prespecified targets, with all efficacy measures demonstrating consistent and significant therapeutic benefits. Study results showed that while TQH2722 significantly improved patients' skin lesion status, it also demonstrated outstanding performance in early itch relief and quality of life improvement; at Week 52, all efficacy endpoints continued to show durable efficacy maintenance and clinical benefit. In terms of safety, TQH2722 demonstrated good safety and tolerability with up to 52 weeks of dosing, consistent with observations at Week 16, with no new safety signals. Atopic dermatitis is a chronic, relapsing, inflammatory skin disease. Patients with moderate-to-severe disease often suffer long-term from multiple burdens including skin lesions, severe itching, sleep disturbance, and reduced quality of life. Epidemiological data show that the global prevalence of atopic dermatitis is approximately 15%20% in children and approximately 6%10% in adults [1]. Precision biologic therapy targeting the core type 2 inflammation pathway is gradually becoming an important direction for systemic treatment of patients with moderate-to-severe atopic dermatitis. In the field of type 2 inflammatory diseases, the Group has built a differentiated pipeline layout around key inflammatory signaling pathways and upstream/downstream targets, including TQH5528 (oral STAT6 degrader), TQC2731 (TSLP monoclonal antibody), TQC2938 (ST2 monoclonal antibody), etc., covering asthma, atopic dermatitis, chronic sinusitis, allergic rhinitis, and other type 2 inflammation-related diseases.