三生国健药业（上海）股份有限公司 关于自愿披露公司重组抗IL-4Rα人源化单克隆抗体注射液新药上市申请获得受理的公告

Core Viewpoint - The company has received a notice of acceptance for its new drug application (NDA) for SSGJ-611, a humanized monoclonal antibody targeting IL-4Rα, from the National Medical Products Administration of China, but the approval process remains uncertain [1][4]. Drug Basic Information - SSGJ-611 is a self-developed humanized monoclonal antibody with a novel amino acid sequence that specifically binds to IL-4Rα, blocking IL-4 and IL-13 signaling pathways to alleviate atopic dermatitis (AD) [2]. - Atopic dermatitis is a chronic, recurrent inflammatory skin disease with limited treatment options, significantly affecting patients' quality of life. The prevalence of AD has been increasing globally over the past 30 years, with an adult prevalence rate of 6.1% in China [2]. Clinical Research Results - The Phase III clinical study of SSGJ-611 in adult patients with moderate to severe atopic dermatitis achieved its primary endpoints, showing significant efficacy compared to the placebo group (P values < 0.0001) [3]. - SSGJ-611 demonstrated a 45.4% response rate in reducing itch severity by ≥4 points from baseline at week 16, compared to 15.6% in the placebo group (P value < 0.0001) [3]. - The maintenance phase of the study showed high retention rates for EASI-75 and IGA 0/1 at week 52, with percentages of 96.9% and 89.6% for the 300 mg Q2W dosing regimen, respectively [3]. - SSGJ-611 exhibited good safety and tolerability throughout the core treatment period and the 52-week treatment duration [3].