Akeso's Ligufalimab Secures FDA Orphan Drug Designation for AML Treatment
Akeso's Ligufalimab Receives Orphan Drug Designation for AML
Akeso Inc. has made a significant announcement on September 15, 2025, regarding its innovative monoclonal antibody, ligufalimab (AK117), which recently received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of acute myeloid leukemia (AML). This designation is part of a program aimed at encouraging the development of treatments for rare diseases, thus providing various benefits such as tax incentives and a period of market exclusivity after approval.
Ligufalimab is a next-generation humanized IgG4 monoclonal antibody specifically targeting CD47, a protein that inhibits the immune response against cancer cells. The drug's mechanism of action centers on blocking the interaction of CD47 with the SIRPα receptor, effectively countering the
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