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. reported record commercial sales in China and significant global advancements in its oncology and autoimmune pipelines for the first half of 2025, driven by its "IO 2.0 + ADC 2.0" strategy [2][11][34] - The company has established itself as a leader in immuno-oncology bispecific antibodies, particularly with cadonilimab and ivonescimab, which are being evaluated in numerous global clinical trials [5][6][9][22] - Akeso's non-oncology portfolio is also expanding, with recent product launches and ongoing developments in autoimmune diseases, contributing to overall growth [10][31][36] Financial Performance - Total commercial sales increased by 49.20%, from RMB 939.4 million in the first half of 2024 to RMB 1,401.6 million in the first half of 2025, reflecting robust market penetration [11] - Research and development expenses for the same period were RMB 731.2 million, with total cash and equivalents amounting to RMB 7,138.4 million as of June 30, 2025 [12] Oncology Pipeline - Ivonescimab and cadonilimab are being evaluated in 23 registrational/Phase III trials and over 20 Phase II studies globally, with ivonescimab demonstrating statistically significant overall survival benefits in its trials [6][8][18] - Cadonilimab has received approvals for multiple indications, including first-line treatments for cervical and gastric cancers, addressing significant unmet needs in immunotherapy [22][23][25] Non-Oncology Pipeline - The company has launched ebdarokimab and ebronucimab, with upcoming launches for gumokimab and manfidokimab, enhancing its competitive position in the autoimmune sector [10][31][35] - Akeso's innovative candidates targeting neurological diseases and other chronic conditions are also progressing through development [32][36] Strategic Initiatives - Akeso is advancing a next-generation pipeline of bispecific ADCs and dual-payload ADCs, aiming to redefine the oncology treatment landscape [27][29] - The company is open to strategic collaborations to enhance its global reach and maximize therapeutic value [26]