Darzalex® is the official global commercial brand name, and Zhaoke is its Chinese brand name developed by Janssen. It is an intravenous fully human anti-CD38 monoclonal antibody. It targets CD38 highly expressed on myeloma plasma cells, exerting multi-mechanism anti-tumor activity including ADCC, CDC and direct tumor cell apoptosis.
Main Indications
Combination therapy or monotherapy for adult patients with newly diagnosed or relapsed/refractory multiple myeloma;
For transplant-ineligible newly diagnosed multiple myeloma, combined with lenalidomide and dexamethasone;
For multi-line pretreated refractory multiple myeloma, single-agent treatment is applicable.
Clinical Research
Global multicenter phase III pivotal trials fully validated its remarkable progression-free and overall survival benefits in both frontline and late-stage multiple myeloma;
Head-to-head controlled registration trials confirmed deeper minimal residual disease negative conversion rate compared with conventional standard regimens;
Long-term follow-up cohorts demonstrated sustained long-term disease control after continuous intravenous maintenance cycles;
Dose-finding research verified balanced anti-myeloma efficacy and infusion-related safety profile of the 100mg per vial standard specification;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse events for domestic myeloma patient populations.
Common Side Effects
Common mild adverse reactions: Infusion-related reactions, fatigue, nausea, back pain, upper respiratory tract infection and diarrhea;
Laboratory abnormalities: Transient neutropenia, thrombocytopenia, lymphopenia and anemia;
Severe but uncommon risks: Severe anaphylactic infusion reactions, grade 4 cytopenia, severe bacterial/viral infections and cardiac adverse events.
Approval Status in China
Original drug Darzalex® (Chinese brand: Zhaoke) was officially approved for marketing in China in 2019, with the specification of 100mg (5mL) per vial, single vial per box. It is a prescription anti-myeloma monoclonal antibody covered by China’s Category B medical insurance catalogue.
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