Akeso Scores Two Wins in Phase 3 Trials, Tees Up Regulatory Submissions in China

Akeso announced positive results from two Phase 3 trials:
gumokimab (IL-17) succeeded in ankylosing spondylitis and manfidokimab (IL-4Rα) succeeded in atopic dermatitis, both achieving their primary endpoints4.

The success in these late-stage studies positions Akeso to submit New Drug Applications (NDAs) for both therapies in China14.

Gumokimab has also demonstrated positive results previously in a pivotal Phase 3 trial in moderate-to-severe psoriasis4.

The company highlighted record commercial sales and ongoing growth in its pipeline, asserting advances in both oncology and autoimmune portfolios1.

Akeso's strategy includes expanding their commercial portfolio with these upcoming launches, which represent the company’s third and fourth commercial products in China1.

Sources:

1. https://www.prnewswire.com/news-releases/akesos-2025-interim-results-commercial-sales-reach-new-all-time-highs-302539063.html

4. https://www.prnewswire.com/news-releases/akeso-reports-phase-3-trials-show-positive-results-gumokimab-il-17-for-ankylosing-spondylitis-and-manfidokimab-il-4r-for-atopic-dermatitis-achieve-primary-endpoints-302537397.html