Qarziba® is the commercial brand name of Dinutuximab beta Injection, a chimeric monoclonal antibody targeting GD2 ganglioside developed by EUSA Pharma. It binds to the GD2 antigen expressed on the surface of neuroblastoma tumor cells, mediates antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to clear neuroblastoma tumor cells and exert anti-tumor immunotherapeutic effects. This product is administered via intravenous infusion only.
Main Indications
Treatment of high-risk neuroblastoma in patients aged 12 months and older who have achieved at least a partial response following induction chemotherapy, subsequent myeloablative therapy and autologous hematopoietic stem cell transplantation;
Treatment of relapsed or refractory neuroblastoma with or without residual lesions in patients aged 12 months and older. For patients with progressive recurrent neuroblastoma, disease stabilization should be achieved prior to administration.
Clinical Research
Global pivotal Phase III clinical trials demonstrated that maintenance therapy with dinutuximab beta significantly prolonged event-free survival and overall survival in pediatric patients with high-risk neuroblastoma after autologous hematopoietic stem cell transplantation, markedly lowering the risk of tumor recurrence;
Registration clinical trials involving Chinese pediatric patients with neuroblastoma confirmed consistent anti-tumor efficacy and controllable safety profiles compared with global study populations, supporting clinical use in Chinese patients with high-risk neuroblastoma;
Chinese real-world clinical research verified robust disease control efficacy when dinutuximab beta was combined with GM-CSF and isotretinoin as first-line maintenance regimen for high-risk neuroblastoma.
Common Side Effects
Predominant adverse reactions include pyrexia (88%), severe neuropathic pain (77%, prophylactic opioid analgesia is routinely required), hypersensitivity reactions (63%), vomiting (57%) and capillary leak syndrome (40%);
Other prevalent adverse reactions consist of diarrhea, anemia, neutropenia, thrombocytopenia, hypotension, abnormal liver function and electrolyte disorders. The majority of adverse reactions are Grade 1–2, which can be effectively managed by symptomatic supportive care and premedication.
Approval Status in China
Qarziba® (Dinutuximab beta Injection) received conditional marketing approval from the National Medical Products Administration (NMPA) on August 12, 2021, and is exclusively marketed in mainland China by BeiGene.
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