莱法利单抗(AK117)
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康方生物CD47单抗获得FDA孤儿药资格认定
Zheng Quan Shi Bao Wang· 2025-09-16 03:48
Group 1 - The core point of the article is that Kangfang Biopharma has received Orphan Drug Designation from the FDA for its new generation anti-CD47 humanized IgG4 monoclonal antibody, Lefalimab (AK117), for the treatment of acute myeloid leukemia (AML) [1] Group 2 - The Orphan Drug Designation is significant as it provides certain benefits, including tax credits for clinical trial costs and market exclusivity for seven years upon approval [1] - The designation highlights the potential of Lefalimab in addressing unmet medical needs in the treatment of AML, a condition with limited effective therapies [1] - This development may enhance Kangfang Biopharma's position in the oncology market and attract potential investors interested in innovative cancer therapies [1]