Hong Kong–listed Sino Biopharmaceutical Limited (SBP Group) announced that China’s Center for Drug Evaluation has formally accepted the New Drug Application (NDA) for TQH2722 Injection, a fully human IL-4Rα monoclonal antibody developed by subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ).

TQH2722 inhibits IL-4- and IL-13-mediated signaling, blocking upstream type 2 inflammatory pathways implicated in atopic dermatitis (AD). The NDA targets adult patients with moderate-to-severe AD who are inadequately controlled by, or unsuitable for, topical therapies.

Regulatory acceptance is supported by the Phase III TQH2722-III-01 trial, a multicenter, randomized, double-blind, placebo-controlled study that enrolled 500 patients. The study met both co-primary efficacy endpoints at Week 16: • ≥75% improvement in Eczema Area and Severity Index (EASI 75); and • Investigator’s Global Assessment (IGA) score of 0/1 (clear/almost clear).

Multiple secondary endpoints also reached preset targets, with durable clinical benefits maintained through Week 52. Safety outcomes showed good tolerability over the 52-week period, with no new safety signals.

Atopic dermatitis affects an estimated 15%–20% of children and 6%–10% of adults globally. Precision biologics that modulate type 2 inflammatory pathways are increasingly central to systemic AD management.

Beyond TQH2722, SBP Group’s type 2 inflammation portfolio includes: • TQH5528 – oral STAT6 degrader • TQC2731 – thymic stromal lymphopoietin (TSLP) monoclonal antibody • TQC2938 – ST2 monoclonal antibody

These assets span indications such as asthma, atopic dermatitis, chronic sinusitis and allergic rhinitis, underscoring the Group’s strategic focus on differentiated immunology therapeutics.