Akeso’s gumokimab (AK111), an anti‑IL‑17 monoclonal antibody, has been approved by China’s NMPA to treat adults with moderate‑to‑severe plaque psoriasis following a pivotal Phase III trial and three supporting studies. At week 12 the drug achieved PASI 75 in 94.6% of patients and PASI 100 in 47.7%, outperforming reported PASI 100 rates of 28.6% for other IL‑17 agents. Responses were durable to week 52 (PASI 100 68.9%), safety was favourable, and the subcutaneous regimen requires only 17 injections per year. The NMPA’s CDE has also accepted a supplemental application for ankylosing spondylitis.
China Approves Akeso’s Gumokimab (AK111) for Moderate-to-Severe Plaque Psoriasis After Strong Phase III Results
At week 12
Akeso has secured approval from China’s National Medical Products Administration (NMPA) for gumokimab (AK111), an anti‑Interleukin‑17 (IL‑17) monoclonal antibody, for the treatment of adults with moderate‑to‑severe plaque psoriasis.
Clinical Evidence
The approval was supported by a pivotal Phase III trial (AK111‑301) and three additional supportive studies. Across the clinical programme, gumokimab demonstrated a rapid onset of action and strong, durable skin clearance rates.
Efficacy Highlights
In the AK111‑301 Phase III study, gumokimab produced a Psoriasis Area and Severity Index 75 (PASI 75) response rate of 94.6% at week 12 and a complete skin clearance rate (PASI 100) of 47.7% at the same time point. By comparison, reported PASI 100 results for other agents in the IL‑17 class were 28.6% in similar settings. Responses remained durable through week 52, with PASI 75 rates approaching 100% and PASI 100 reaching 68.9%.
Safety and Dosing
Safety findings were favourable: incidences of treatment‑emergent adverse events (TEAEs), serious adverse events (SAEs) and infections were reported among the lowest observed in trials of IL‑17 inhibitors. Gumokimab is administered subcutaneously and requires 17 injections per year, including the loading phase — roughly half the annual injection burden of some competing IL‑17 therapies.
Study Leadership and Company Comments
Professor Xu Jinhua of Huashan Hospital, Fudan University served as the principal investigator for the AK111‑301 trial.
Dr Xia Yu, Akeso’s founder, chairwoman, president and CEO, said: “To better address patients' diverse needs, Akeso has successfully developed and launched ebdarokimab and gumokimab, two therapies targeting distinct pathogenic pathways that complement each other. The autoimmune disease field remains one of the largest and fastest‑growing areas in innovative drug development. With these two approvals, we have built a strong, differentiated portfolio for psoriasis.”
Regulatory Next Steps
Separately, the NMPA’s Center for Drug Evaluation (CDE) has accepted a supplemental new drug application seeking approval of gumokimab for active ankylosing spondylitis.
Source: Originally reported by Pharmaceutical Technology (a GlobalData brand).
Note: This article summarises clinical and regulatory data reported by the company and published sources. Readers should consult full study reports and regulatory documents for complete information.
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