SBP GROUP (01177.HK): NDA for TQH2722 "IL-4Rα Antibody" Accepted for Review

NewTimeSpace · 2026/09/16 07:41 · By Xuran Lin

On 16 September 2026, SBP GROUP (01177.HK) announced that the NDA for TQH2722 injection (an IL-4Rα monoclonal antibody), a National Class 1 innovative drug independently developed by its subsidiary Chia Tai Tianqing, has been accepted for review by the CDE, for moderate-to-severe atopic dermatitis in adults.

Key Highlights:

TQH2722 is a fully human monoclonal antibody targeting IL-4Rα that inhibits both IL-4 and IL-13 mediated signalling activation, blocking the type 2 inflammatory pathway upstream.
Both co-primary endpoints, the week 16 EASI 75 response rate and the IGA 0/1 response rate, were met, and multiple secondary endpoints also reached pre-specified targets.
Global prevalence of atopic dermatitis is approximately 15% to 20% in children and 6% to 10% in adults; the Group's type 2 inflammation pipeline also includes TQH5528, TQC2731 and TQC2938.

NewTimeSpace (newtimespace.com) News: On 16 September 2026, Sino Biopharmaceutical Limited (stock code: 01177) announced that the new drug application for TQH2722 injection (an IL-4Rα monoclonal antibody), a National Class 1 innovative drug independently developed by the Group's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has been submitted to and accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, for adults with moderate-to-severe atopic dermatitis (AD) that is inadequately controlled by or unsuitable for topical treatment.

The acceptance of the new drug application is based on positive clinical results from the TQH2722-III-01 study. The study is a multicentre, randomised, double-blind, placebo-controlled Phase III clinical study evaluating TQH2722 in moderate-to-severe atopic dermatitis, enrolling 500 patients, and the results showed consistent significant treatment benefits across efficacy measures.

The results showed that TQH2722 significantly improved patients' skin lesions while also performing well in early itch relief and quality-of-life improvement; at week 52, all efficacy endpoints continued to show durable maintenance of efficacy and clinical benefit. On safety, TQH2722 was well tolerated with a safety profile consistent with week 16 observations and no new safety signals after up to 52 weeks of dosing. In the type 2 inflammatory disease area, the Group has built a differentiated pipeline around key inflammatory signalling pathways and upstream and downstream targets, including TQH5528 (oral STAT6 degrader), TQC2731 (TSLP monoclonal antibody) and TQC2938 (ST2 monoclonal antibody).

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