QL2109

**QL2109** is a Qilu Pharmaceutical investigational biosimilar of daratumumab, an anti-CD38 monoclonal antibody for multiple myeloma. The subcutaneous formulation is co-formulated with recombinant human hyaluronidase to facilitate subcutaneous delivery, analogous to daratumumab and hyaluronidase-fihj. By binding CD38 on malignant plasma cells, it is intended to promote immune-mediated tumor-cell killing through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, antibody-dependent cellular phagocytosis, and direct apoptotic signaling. QL2109 has demonstrated pharmacokinetic similarity, comparable safety, and comparable immunogenicity versus the reference subcutaneous daratumumab product in healthy adult men, and is in Phase 3 development with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma.

Other names

daratumumab biosimilardaratumumab/hyaluronidase biosimilar