HK Stock Market Move | AKESO(09926) rose nearly 3% in early trading. Recently, the CD47 Lafflet single antibody was granted FDA orphan drug status.

AKESO (09926) rose nearly 3% in early trading, rising 1.98% to HK$133.5 as of the time of writing, with a turnover of HK$1.5 billion. On the news front, according to AKESO's official WeChat account, the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AKESO's self-developed next-generation anti-CD47 humanized IgG4 monoclonal antibody lenafolimab (AK117) for the indication of acute myeloid leukemia (AML). Orphan Drug Designation is a special incentive policy set up by the FDA to encourage the development of drugs for rare diseases. This will help the drug enjoy many positive policy supports in the United States for its subsequent development and commercialization, including clinical trial cost tax relief, exemption from BLA application fees, research and development funding, and market exclusivity in the United States for 7 years after approval for this indication. Obtaining this designation is an acknowledgment and expectation of the clinical value potential of lenafolimab by the FDA. Lenafolimab is an anti-CD47 humanized IgG4 monoclonal antibody that specifically binds to CD47 expressed on the surface of tumor cells, blocking its interaction with the SIRP receptor, removing the "do not eat me" signal, enhancing the phagocytosis of tumor cells by macrophages, and inhibiting tumor growth. It is worth noting that, thanks to its unique drug design, lenafolimab does not induce red blood cell aggregation, and its safety and efficacy are significantly better than other drugs targeting the same target. The efficacy, safety, and convenience of use are significantly improved.