Akeso Inc. (AKESF,9926.HK) announced that its proprietary next-generation humanized IgG4 monoclonal antibody targeting CD47, ligufalimab (AK117), has been granted Orphan Drug Designation by the U.S. FDA for the treatment of acute myeloid leukemia (AML).
The Orphan Drug Designation is a program established by the FDA to incentivize the development of therapies for rare diseases. Drugs granted this designation benefit from comprehensive FDA guidance during development, tax incentives, and up to seven years of market exclusivity upon approval.
Akeso said it is actively advancing the global clinical development of ligufalimab, which is being evaluated in both hematologic malignancies and solid tumors. In addition to its application in AML, patient enrollment has been completed in a randomized, double-blind, multicenter Phase II study assessing ligufalimab in combination with azacitidine for higher-risk myelodysplastic syndromes (HR-MDS).
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