Akeso, established by a team of scientists with global experience in 2012,has been dedicated to discovery, development, manufacturing and commercialization of first-in-class and best-in-class innovative antibody drugs.In April 2020, Akeso was listed on the main board of the Hong Kong Stock Exchange (Stock Code: 9926).
Since our establishment, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and have established a research and development innovation system encompassing core technologies such as Tetrabody BsAb development technology, ADC technology, mRNA technology and cell therapy technology,a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode.
After 13 years of pioneering innovation,focusing on the unmet needs worldwide in major diseases, such as cancer, autoimmune diseases, inflammation and metabolic diseases, Akeso has developed over 50 innovative antibody drugs with full proprietary intellectual property rights, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs.Akeso is one of the innovative antibody drug R&D enterprises with the richest and most diversified pipelines in China, In 2024, Akeso was ranked 203rd on the 'Hurun China 500 Most Valuable Private Companies' list.
Akeso has successfully commercialized 7 fully independent, first-in-class/best in-class innovative new drugs, and 2 new drugs with multiple indications are under regulatory review for approval.
In August 2021,安尼可® (PD-1 monoclonal antibody, penpulimab-kcqx) was granted marketing approval in China.
In June 2022, 开坦尼®(PD-1/CTLA-4 bi-specific antibody, cadonilimab) was approved by the NMPA and became the first tumor dual immune checkpoint inhibitor bi-specific antibody approved for marketing globally.The indications approved of cadonilimab currently are the first-line treatment for persistent, recurrent, or metastatic cervical cancer,and Gastric/GEJ Cancer in All-Comers Population.In May 2024, 依达方® (PD-1/VEGF bi-specific antibody,ivonescimab) , the first-in-class PD-1/VEGF bi-specific antibody independently developed by the Company, has been granted marketing approval by the NMPA of China for the treatment of epidermal growth factor receptor (“EGFR”) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (“nsq-NSCLC”) .Meanwhile,ivonescimab monotherapy decisively beats pembrolizumab monotherapy head-to-head, achieving statistically significant superiority in PFS in first-line treatment of patients with PD-L1 positive NSCLC,reducing the risk of disease progression or death by 49%.
开坦尼®(cadonilimab injection) and 依达方®(ivonescimab injection) have both been included in the most recent National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration.
In September 2024，Akeso’s first non-oncology drug 伊喜宁®（PCSK9 monoclonal antibody，ebronucimab) has been approved by the NMPA in China for two indications of hypercholesterolemia; In April 2025,the first Class 1 new drug approved for autoimmune diseases of Akeso,the IL-12/IL-23 dual-targeted monoclonal antibody 爱达罗®(ebdarokimab) has been granted marketing approval by the NMPA of China for the treatment of moderate-to-severe plaque psoriasis,which expands Akeso's commercial portfolio outside of oncology.
After trailblazing in innovative pharmaceuticals by out-licensed CTLA-4 antibody(AK107) to Merck & Co.as the first China-based biotech company in 2015,the company out-licensed the antibody with up to US$5 Billion total potential deal value to Summit Therapeutics for development and commercialization in certain territories including the U.S., Canada, Europe, and Japan.This partnership set a new record for the license-out transaction of an in-house developed new drug from China.In February 2025，Summit Therapeutics has entered into a clinical trial collaboration with Pfizer to evalsuate ivonescimab in combination with several of Pfizer's antibody drug conjugates (ADCs) across multiple solid tumor settings.In April 2025， the U.S. Food and Drug Administration (FDA) has approved the differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with at least one other prior line of therapy.
Through efficient and breakthrough R&D innovation, Akeso always integrate superior global resources, develop the first-in-class and best-in-class new drugs, provide affordable therapeutic antibodies for patients worldwide, and continuously create more commercial and social values so as to become a global leading biopharmaceutical enterprise.