Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that Amdokitug (Yisaituo), its independently developed anti-IL-17A humanized monoclonal antibody, has received NMPA approval for adult patients with moderate-to-severe plaque psoriasis eligible for systemic therapy or phototherapy. The Category 1 biological product, featuring optimized immunogenicity screening to reduce anti-drug antibody (ADA) formation, demonstrated superior skin clearance rates (PASI 100) and durable efficacy in Phase 3 studies, positioning as a next-generation IL-17A inhibitor in China’s rapidly expanding immunology market.
>6 million patients with moderate-to-severe disease; IL-17A class (secukinumab, ixekizumab) rapidly displacing TNF inhibitors due to superior skin clearance
Amdokitug Differentiation
Optimized immunogenicity addresses ADA-mediated loss of efficacy seen with originator secukinumab; potential for sustained long-term response
Forward‑Looking Statements This brief contains forward‑looking statements regarding Amdokitug commercial launch success, NRDL reimbursement outcomes, and competitive positioning vs. secukinumab and ixekizumab in China. Actual results may differ due to pricing pressure from national procurement programs, physician prescribing habits, and immunogenicity profile validation in real-world use.-Fineline Info & Tech
By Fineline Cube