Akeso’s Gumokimab Approved by China’s NMPA for Plaque Psoriasis

The National Medical Products Administration (NMPA) of China has approved Akeso Inc.’s gumokimab (AK111), an internally-developed anti-IL-17 monoclonal antibody, for the treatment of adult patients with moderate-to-severe plaque psoriasis.

The approval was supported by one pivotal Phase III clinical study (AK111-301) and three supportive studies. Study results demonstrate gumokimab’s rapid and robust efficacy, durable complete skin clearance, and favorable safety and dosing profile. Treatment demonstrated rapid onset of action, with clinically meaningful improvement observed as early as Week 2.

Professor Xu Jinhua, Principal Investigator of the pivotal Phase III registration study for gumokimab at Huashan Hospital, Fudan University, said, “Gumokimab, an IgG1 monoclonal antibody that precisely targets IL-17, has demonstrated rapid onset, strong short-term efficacy, durable long-term control, and a favorable safety profile in clinical studies. We are delighted by its approval, which offers patients a more effective, convenient, and reliable new treatment option.”

In addition to moderate-to-severe plaque psoriasis, a supplemental New Drug Application (sNDA) for gumokimab in active ankylosing spondylitis has been accepted for review by the Center for Drug Evaluation (CDE) of the NMPA.