Akeso Announces NMPA Acceptance of Second NDA for Gumokimab (IL-17A Inhibitor) in Active Ankylosing Spondylitis

Core Viewpoint - Akeso, Inc. has received acceptance for its supplemental New Drug Application (sNDA) for gumokimab, a novel treatment for active ankylosing spondylitis, from the National Medical Products Administration (NMPA) in China, indicating a significant step forward in addressing the needs of approximately 4 million AS patients in the country [1][4]. Group 1: Drug Development and Regulatory Progress - Gumokimab is the second indication for which Akeso has gained NDA review acceptance, following its previous acceptance for treating moderate-to-severe psoriasis in January 2025 [2]. - Gumokimab is Akeso's third non-oncology drug candidate to enter the regulatory review phase, alongside ebronucimab and ebdarokimab, showcasing the company's expanding non-oncology portfolio [3]. - The NDA acceptance for gumokimab is based on positive results from the pivotal Phase III clinical trial (AK111-303), which demonstrated effective alleviation of AS symptoms and significant improvements in patients' activity, physical function, and quality of life [4]. Group 2: Company Overview and Pipeline - Akeso is a leading biopharmaceutical company founded in 2012, focused on the research, development, manufacturing, and commercialization of innovative biological medicines, with a robust pipeline of over 50 innovative assets across various disease areas [8][9]. - The company has developed a unique integrated R&D innovation system, including the ACE Platform for drug development and Tetrabody technology for bispecific antibody development, positioning itself as a globally competitive biopharmaceutical entity [8]. - Akeso has 26 candidates in clinical trials, including 15 bispecific/multispecific antibodies, and has successfully launched 7 new drugs commercially, emphasizing its commitment to delivering affordable therapeutic antibodies [9].