AKESO(HK:09926) Zhi Tong Cai Jing·2025-09-19 01:44Core Viewpoint - Kangfang Biopharma (09926) 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 Biopharma'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 FDA's Orphan Drug Designation provides various incentives for the development and commercialization of Lefacitinib, including tax credits for clinical trial costs, waiver of BLA application fees, and potential seven years of market exclusivity upon approval [1] Group 2: Product Information - Lefacitinib specifically binds to CD47 expressed on tumor cells, blocking its interaction with the SIRPα receptor, thereby enhancing macrophage phagocytosis of tumor cells and inhibiting tumor growth [2] - The unique design of Lefacitinib prevents red blood cell aggregation, significantly improving the drug's safety and efficacy compared to other drugs targeting the same pathway, enhancing therapeutic effectiveness and convenience [2]