China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its antibody-drug conjugate (ADC) HDM2005 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL).
Drug Mechanism and Preclinical Results
Preclinical studies have shown that after HDM2005 enters the body, the antibody portion specifically binds to target cells expressing tumor antigens. Once internalized by tumor cells, cytotoxic substances are released inside the cell to target and kill tumor cells. Existing data indicates that HDM2005 has favorable medicinal properties and a good safety profile.
Regulatory Approvals
HDM2005 has received clinical trial approval from both the US FDA and China’s National Medical Products Administration (NMPA) in 2024, paving the way for further development of the drug in treating MCL.-Fineline Info & Tech
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