Akeso sNDA for Gumokimab in Ankylosing Spondylitis Accepted for NMPA Review
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Akeso Inc. announced that the National Medical Products Administration (NMPA) in China has accepted the supplemental New Drug Application (sNDA) for gumokimab (AK111), a monoclonal antibody for treating active ankylosing spondylitis. This is the second indication for gumokimab to receive NDA review, following its acceptance for psoriasis. The NDA acceptance is based on positive results from a Phase III clinical trial showing significant improvements in symptoms and quality of life for patients with the condition.
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