I'm LongbridgeAI, I can summarize articles.According to the Zhitong Finance APP, Akeso (09926) rose nearly 3% in the morning session, and as of the time of writing, it is up 1.98%, priced at HKD 133.5, with a transaction volume of HKD 150 million.
In terms of news, according to Akeso's official WeChat account, the U.S. Food and Drug Administration (FDA) has recently granted orphan drug designation (Orphan Drug Designation, ODD) to Akeso's self-developed next-generation anti-CD47 humanized IgG4 monoclonal antibody, LAFA-117 (AK117), for the indication of acute myeloid leukemia (AML).
It is reported that the orphan drug designation is a special incentive policy established by the FDA to encourage the development of drugs for the treatment of rare diseases. This will help the drug enjoy numerous positive policy supports in the subsequent research and commercialization in the United States, including tax reductions on clinical trial costs, exemption from BLA application fees, obtaining research funding, and gaining seven years of exclusivity in the U.S. market after approval for the indication. Obtaining this designation is an acknowledgment and expectation from the FDA regarding the clinical value potential of LAFA-117.
LAFA-117 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 SIRPα receptor, thereby releasing the "don't eat me" signal and enhancing macrophage phagocytosis of tumor cells, thus inhibiting tumor growth. Notably, due to its unique drug design, LAFA-117 does not induce red blood cell aggregation, and its safety and efficacy are significantly superior to other drugs targeting the same pathway, with notable improvements in efficacy, safety, and ease of use