AKESO(HK:09926) Zhi Tong Cai Jing·2025-09-19 01:45Core Viewpoint - Kangfang Biotech (09926) has received Orphan Drug Designation from the FDA for its novel anti-CD47 humanized IgG4 monoclonal antibody, Lefacitinib (AK117), for the treatment of acute myeloid leukemia (AML) [1][2] Group 1: Company Developments - Kangfang Biotech's stock rose nearly 3% in early trading, currently up 1.98% at HKD 133.5, with a trading volume of HKD 150 million [1] - The Orphan Drug Designation will provide various incentives for the development and commercialization of Lefacitinib in the U.S., including tax credits for clinical trial costs, waiver of BLA application fees, and potential R&D funding [1] Group 2: Product Details - Lefacitinib specifically binds to CD47 expressed on tumor cells, blocking its interaction with the SIRPα receptor, which enhances macrophage phagocytosis of tumor cells and inhibits tumor growth [2] - The drug's unique design prevents red blood cell aggregation, significantly improving its safety and efficacy compared to other drugs targeting the same pathway, enhancing therapeutic convenience [2]