AKESO(09926.HK): Qiyoukang® (Gumokimab) Approved by NMPA for Moderate-to-Severe Plaque Psoriasis

NewTimeSpace News: Akeso Biopharma (Cayman) Limited (09926.HK) issued a voluntary announcement on June 12, 2026, disclosing that the New Drug Application for Qiyoukang® (Gumokimab, AK111) has been approved by the National Medical Products Administration of China.
Gumokimab is a novel humanized IL-17 therapeutic drug for autoimmune diseases independently developed by the Company, intended for the treatment of psoriasis, ankylosing spondylitis and other autoimmune diseases. The current approval for moderate-to-severe plaque psoriasis is based on one key Phase III clinical study (AK111-301) and three supportive studies.
Clinical data indicate that the drug delivers rapid and potent efficacy at Week 12, with a PASI 75 response rate of 94.6% and a PASI 100 (complete lesion clearance) response rate of 47.7%, compared with 28.6% of other drugs targeting the same pathway. It achieves sustained complete lesion clearance at Week 52: the PASI 75 response rate, a long-term efficacy endpoint, is nearly 100%, and the PASI 100 response rate is 68.9%, while the figure of other drugs targeting the same pathway is 39.2%. The product boasts good safety performance, with the lowest incidence of adverse events, serious adverse events, infections and invasive diseases during the treatment among similar drugs targeting the same pathway. It is also easy to administer with one injection per time, totaling 17 injections a year, compared with 34 injections required by other drugs targeting the same pathway.
At present, the New Drug Application of Gumokimab for the treatment of active ankylosing spondylitis has been accepted and is under review by the Center for Drug Evaluation of the National Medical Products Administration of China.

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