Sarclisa® is the official global commercial brand name, and Saikeyi is its Chinese brand name developed by Sanofi. It is an intravenous anti-CD38 monoclonal antibody. It binds to CD38 expressed on myeloma cells, triggering multiple tumor-killing mechanisms including antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity and direct apoptosis of malignant plasma cells.
Main Indications
Combined with pomalidomide and dexamethasone for relapsed/refractory multiple myeloma adult patients who have received at least two prior lines of therapy including lenalidomide and a proteasome inhibitor;
Combined with carfilzomib and dexamethasone for relapsed/refractory multiple myeloma adult patients with 1–3 prior treatment regimens.
Clinical Research
Global multicenter phase III ICARIA-MM pivotal trials fully validated its significant progression-free survival benefit for multi-line refractory multiple myeloma;
Head-to-head controlled registration trials confirmed deeper tumor remission and prolonged survival when added to pomalidomide-dexamethasone backbone therapy;
Long-term open-label extension cohorts demonstrated sustained disease control under repeated intravenous maintenance cycles;
Dose-finding research verified balanced anti-myeloma efficacy and infusion safety profile of the 500mg standard infusion dose;
Chinese domestic registration trials confirmed consistent therapeutic activity and manageable adverse reaction spectrum for domestic relapsed/refractory myeloma populations.
Common Side Effects
Common mild adverse reactions: Infusion-related reactions, neutropenia, thrombocytopenia, fatigue, pneumonia and diarrhea;
Laboratory abnormalities: Severe transient leukopenia, decreased hemoglobin and hypogammaglobulinemia;
Severe but uncommon risks: Severe anaphylactic infusion reactions, grade 4 prolonged neutropenia, severe infectious complications and cardiac adverse events.
Approval Status in China
Original drug Sarclisa® (Chinese brand: Saikeyi) was officially approved for marketing in China in 2021, with the specification of 500mg (25mL) per vial, 1 vial per box. It is currently a prescription anti-myeloma monoclonal antibody included in China’s Category B medical insurance catalogue.
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