Akeso Biopharma Gains NMPA Approval for AK112 and AK119 Clinical Study

China-based Akeso Biopharma (HKG: 9926) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in combination with its anti-CD73 monoclonal antibody (mAb) AK119 for the treatment of advanced solid tumors.

AK112 and AK119: Mechanism and Development
AK112 is designed to block the PD-1 and VEGF pathways simultaneously, aiming to produce synergistic anti-tumor effects. The drug has demonstrated efficacy in renal cell carcinoma, non-small cell lung cancer, hepatocellular carcinoma, and other tumors. AK119, on the other hand, has shown the ability in clinical trials to regulate the expression of CD69 and CD83, markers of early B cell activation, and promote the production of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies. There is no similar product successfully developed or commercialized with the same target molecules anywhere in the world.

Future Outlook
The approval from the NMPA underscores Akeso Biopharma’s commitment to advancing innovative cancer therapies. By combining AK112 and AK119, Akeso aims to enhance the treatment options for patients with advanced solid tumors and address significant unmet medical needs in oncology.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry