China’s NMPA approves Akeso’s IL-17A gumokimab for moderate-to-severe plaque psoriasis

Edited by Robert McTiernan··2 min read

China’s NMPA approves Akeso’s gumokimab (AK111) for moderate-to-severe plaque psoriasis, adding a domestically developed anti-IL-17 monoclonal antibody to a class previously dominated by Novartis’s secukinumab (Cosentyx) and Eli Lilly’s ixekizumab (Taltz). For China-based Akeso (HKEX: 9926.HK), the approval marks the company’s second psoriasis biologic on the market, alongside the separately approved IL-12/IL-23-targeted ebdarokimab.

Gumokimab is a subcutaneously administered IgG1 monoclonal antibody that selectively neutralizes IL-17A, a pro-inflammatory cytokine central to the pathogenesis of plaque psoriasis. The approved regimen requires approximately 17 injections annually, including a loading phase — roughly half the annual injection burden reported for some existing IL-17 inhibitors with more frequent maintenance dosing schedules.

The approval was supported by a pivotal Phase III study (AK111-301) and three supportive studies. In the pivotal trial, gumokimab achieved a PASI 75 response rate of 94.6% and a PASI 100 (complete skin clearance) rate of 47.7% at Week 12, compared with a 28.6% PASI 100 rate reported for other agents in the same class at the same timepoint. Clinically meaningful improvement was observed as early as Week 2. At Week 52, the PASI 75 response rate approached 100%, and the PASI 100 rate reached 68.9%, versus 39.2% reported for comparator IL-17 inhibitors. Rates of treatment-emergent adverse events, serious adverse events, and infections were described as numerically among the lowest reported in pivotal IL-17 inhibitor trials, though no head-to-head safety comparisons were conducted.

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By selectively targeting IL-17A, gumokimab blocks a cytokine that drives keratinocyte proliferation and neutrophil recruitment in psoriatic skin. The IgG1 subclass and subcutaneous route are consistent with established IL-17 inhibitor design; the differentiation Akeso emphasizes is the extended dosing interval, which the company suggests may support long-term adherence in a chronic condition requiring sustained treatment.

The approval positions gumokimab within a competitive IL-17 inhibitor class that includes secukinumab and ixekizumab, both approved in China. The psoriasis biologic landscape is also expanding beyond injectable IL-17 agents — Takeda’s zasocitinib recently demonstrated Phase III efficacy in the same indication as an oral TYK2 inhibitor, while J&J’s Icotyde has received FDA approval for plaque psoriasis. Akeso has also filed a supplemental NDA for gumokimab in active ankylosing spondylitis, which has been accepted for review by China’s Center for Drug Evaluation, consistent with the broader rheumatology indications pursued by other IL-17 inhibitors in the class.

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