Sansheng Guojian(688336) announced on February 26 that the company recently received an "Acceptance Notice" issued by the National Medical Products Administration, and the new drug application for its independently developed recombinant anti-IL-4Rα humanized monoclonal antibody injection (research code: SSGJ-611) has been accepted.

According to the announcement, SSGJ-611 is a monoclonal antibody against IL-4Rα independently developed by the company. It has a novel amino acid sequence and can specifically bind to IL-4Rα, blocking IL-4 and IL-13 signaling, thereby alleviating diseases such as atopic dermatitis. Atopic dermatitis is a chronic, relapsing, inflammatory skin disease. Moderate to severe cases often present with generalized rashes, accompanied by intense itching, dry skin, and crusting. Treatment options are limited, severely impacting quality of life. The global prevalence has gradually increased over the past 30 years, with a prevalence rate of 6.1% among adults in my country.

The announcement stated that the Phase III clinical trial conducted in Chinese adults with moderate to severe atopic dermatitis has met its primary endpoint: the experimental group significantly outperformed the placebo group in both the EASI-75 and IGA 0/1 primary efficacy endpoints at week 16. Simultaneously, SSGJ-611 demonstrated a significant pruritus-relieving effect, with a ≥4-point reduction in the weekly mean NRS score for pruritus at week 16, a response rate of 45.4%, significantly higher than the 15.6% in the placebo group. During the maintenance phase, with different doses administered, the percentages of subjects maintaining EASI-75 at week 52 were 96.9% and 95.8%, respectively, and the percentages maintaining IGA 0/1 were 89.6% and 89.1%, respectively, showing a higher maintenance rate trend than other similar trial designs for the same target antibody. SSGJ-611 demonstrated good safety and tolerability during both the core treatment phase and the extended 52-week treatment period.

3SBio's main products include Yisaipu, Saiputing, and Jiannipai. The company expects its net profit attributable to the parent company to be 2.9 billion yuan in 2025, a year-on-year increase of 311.35%; its net profit excluding non-recurring items is expected to be 2.8 billion yuan, a year-on-year increase of 1038.21%.

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