Gazyva® is the official global commercial brand name, and Jialuohua is its Chinese brand name developed by Roche. It is a humanized anti-CD20 type II monoclonal antibody for intravenous infusion. It induces direct B-cell death and antibody-dependent cellular cytotoxicity, depleting malignant CD20-positive B lymphocytes.
Main Indications
Combined with chlorambucil for untreated chronic lymphocytic leukemia in adult patients with co-morbidities;
Combined with bendamustine followed by Gazyva maintenance for relapsed/refractory follicular lymphoma;
Combined with chemotherapy for previously untreated advanced follicular lymphoma, followed by maintenance monotherapy.
Clinical Research
Global multicenter phase III pivotal trials fully validated superior progression-free survival versus rituximab-containing regimens for CD20-positive B-cell malignancies;
Head-to-head comparative registration trials confirmed deeper and longer-lasting B-cell depletion and lower early disease progression risk in follicular lymphoma;
Long-term maintenance follow-up cohorts demonstrated sustained disease control and reduced recurrence rate after induction chemoimmunotherapy;
Dose-finding research verified balanced anti-tumor efficacy and infusion-related safety profile of the 1000mg fixed-dose intravenous schedule;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable infusion reactions for domestic B-cell lymphoma and CLL patient populations.
Common Side Effects
Common mild adverse reactions: Infusion-related reactions, neutropenia, thrombocytopenia, fatigue, diarrhea and cough;
Laboratory abnormalities: Transient grade 1–2 leukopenia, lymphopenia and hypogammaglobulinemia;
Severe but uncommon risks: Severe anaphylactic infusion reactions, severe prolonged neutropenia, progressive multifocal leukoencephalopathy (PML), severe infectious complications and tumor lysis syndrome.
Approval Status in China
Original drug Gazyva® (Chinese brand: Jialuohua) was officially approved for marketing in China in 2021, with the specification of 1000mg (40mL) per vial, 1 vial per box. It is currently a prescription anti-tumor monoclonal antibody included in China’s Category B medical insurance catalogue.
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