Akeso is committed to developing first-in-class and best-in-class new drugs through efficient and groundbreaking R&D innovation. Since its establishment, the Company has been committed to building fully integrated internal development capabilities. An end-to-end drug development platform, the Akeso Comprehensive Exploration Platform (ACE Platform), has been developed with great foresight, encompassing functionalities including drug target validation, antibody discovery and preclinical study, CMC manufacturing process development and GMP-compliant commercialization production.
The ACE platform runs through the full life cycle of drug candidates through development to production and commercialization, and reducing our reliance on the external service system. In addition,it ensures and promote the efficient operation of the new drug development process, thereby increasing the possibility of success rate and reducing the development cost. Based on this platform, we have developed over 30 innovative drug candidates with fully independent intellectual property rights, focusing on major diseases such as tumors and autoimmune, inflammatory and metabolic diseases. Among them, 17 drug candidates have entered clinical strage, with their production processes being developed by the internal platform.
Tetrabody technology is a proprietary technology independently developed by Akeso for the design and manufacture of innovative tetravalent bispecific antibodies. It overcomes CMC challenges such as low expression levels due to the high molecular weight of bispecific antibodies, process development obstacles due to the structural heterogeneity of bispecific antibodies, and non-druggability due to the lack of stability of bispecific antibodies.
Using our unique Tetrabody technology, we have successfully developed six world-leading bispecific antibody drugs, including开坦尼® (PD-1/CTLA-4 bispecific antibody, Cadonilimab injection), Ivonescimab (AK112) and AK130. 开坦尼® is the world's first commercialized dual immune checkpoint inhibitor bispecific antibody to treat cancer. ; Ivonescimab is the world's first PD-1/VEGF bispecific antibody drug entered Phase III; and AK130 is the world's first and only TIGIT/TGF-β dual-targeting antibody fusion protein in research. This results fully demonstrate the strength of Akeso's innovative development strength and its leading position in the field of bispecific antibodies.
In order to effectively improve the efficacy of antibody drug therapy and develop more and better therapies for patients worldwide, Akeso actively explores treatment regimens such as combining chemotherapy and targeted drugs. Bispecific antibodies can block the biological functions mediated by two antigens/epitopes simultaneously, and are expected to induce potential superior biological effects that have never been achieved by single-target antibodies, giving the combination of targeted therapy and chemotherapy broad prospects. We believe some of our commercialized drugs and drug candidates have the potential to be the backbone drugs of combination therapies.
Akeso is vigorously promoting research on bispecific antibody-based combination therapies and pushing tumor immunotherapy into the era of 2.0 . As of the end of 2022, a total of 33 combination therapies based on bispecific antibodies had been effectively implemented. Based on Cadonilimab and Ivonescimab, the exploration of combination therapies with many self-developed products or other drugs has shown promising synergies, and is expected to provide patients with superior therapeutic benefit. The social and industrial value of Akeso's innovative drugs will be fully presented in this development strategy.