Core Insights - Akeso, Inc. has received approval from the National Medical Products Administration in China to initiate Phase II clinical trials for its bispecific antibody AK139, targeting multiple respiratory and autoimmune indications [1] - The indications for AK139 include chronic obstructive pulmonary disease (COPD), severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, chronic rhinosinusitis with nasal polyps, moderate-to-severe atopic dermatitis, and prurigo nodularis [1] - AK139 is the first bispecific antibody targeting IL-4R and ST2 pathways, aiming to address significant unmet clinical needs in chronic inflammatory diseases [1] Company Overview - Akeso is a leading biopharmaceutical company founded in 2012, focusing on the research, development, manufacturing, and commercialization of innovative biological medicines [2] - The company has developed a robust R&D ecosystem centered on its proprietary Tetrabody bispecific antibody platform and has over 50 innovative assets in its pipeline, with 26 candidates currently in clinical trials [2] - Akeso aims to provide affordable therapeutic antibodies and create significant commercial and social value, positioning itself as a global leader in the biopharmaceutical industry [2]

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].

Core Insights - Akeso Inc. announced positive results from its Phase 3 clinical trial of gumokimab (AK111) for active ankylosing spondylitis (AS), meeting all primary efficacy endpoints and key secondary endpoints [1][2] - Gumokimab has shown rapid and effective alleviation of AS symptoms, improving disease activity, physical function, and quality of life for approximately 4 million AS patients in China [2] - Akeso's manfidokimab (AK120) also achieved positive outcomes in its Phase 3 trial for moderate-to-severe atopic dermatitis (AD), meeting all primary and key secondary endpoints [3][4] Company Developments - Akeso plans to file New Drug Applications (NDA) for both gumokimab and manfidokimab, marking significant milestones in the company's expanding autoimmune pipeline [4] - The successful market launches of ebronucimab and ebdarokimab, along with recent positive Phase 3 studies, are expected to drive commercial growth for Akeso's non-oncology franchise [5] - Akeso's robust pipeline includes over 50 innovative assets, with 24 candidates in clinical trials and 7 new drugs already commercially available [9]