China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic product HDM2005 combined with rituximab, cyclophosphamide, doxorubicin, and prednisone in diffuse large B-cell lymphoma (DLBCL) that has not been systematically treated in the past.
HDM2005 Overview
HDM2005 is an antibody drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). The drug has previously received clearance in both China and the US for studies in advanced malignancies. The Phase I study in China has completed four dosage escalations with no dose-limiting toxicity (DLT). Additionally, HDM2005 was awarded Orphan Drug Designation (ODD) in the US in February of this year for the treatment of mantle cell lymphoma (MCL).-Fineline Info & Tech
