AKESO's Novel Drug AK111 Receives Marketing Authorization from Chinese Regulators for Plaque Psoriasis

Stock News06-12

AKESO has announced that its drug Qiyoukang® (Gumoqimab, AK111) has received marketing approval from China's National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis.

The approval for Gumoqimab in this indication is based on one pivotal Phase III clinical study (AK111-301) and three supportive studies.

Gumoqimab is a novel, self-developed, humanized IL-17 (interleukin-17) therapy for autoimmune diseases, designed to treat conditions such as psoriasis and ankylosing spondylitis.

At present, the registrational Phase III clinical studies for Gumoqimab treating moderate-to-severe plaque psoriasis and ankylosing spondylitis have both met all primary efficacy endpoints.

Consequently, the drug is now approved for marketing for moderate to severe plaque psoriasis, and its new drug application for treating active ankylosing spondylitis has been accepted for review by the NMPA's Center for Drug Evaluation.

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