Halaven® is the official global commercial brand name, and Hailewei is its Chinese brand name developed by Eisai. It is an intravenous non-taxane microtubule dynamics inhibitor. It suppresses microtubule polymerization and promotes tubulin depolymerization, blocking mitosis and triggering apoptosis in proliferative tumor cells.
Main Indications
Treatment of adult patients with unresectable or metastatic liposarcoma who have received prior anthracycline-containing chemotherapy;
Treatment of adult patients with locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens including anthracyclines and taxanes.
Clinical Research
Global multicenter phase III pivotal trials fully validated its significant overall survival benefit for pretreated metastatic breast cancer patients versus conventional chemotherapy control groups;
Head-to-head controlled registration trials confirmed durable tumor control and prolonged survival for advanced liposarcoma patients who failed standard first-line therapy;
Long-term follow-up extension cohorts demonstrated consistent anti-tumor activity and stable safety profile under repeated 21-day intravenous treatment cycles;
Dose-finding research verified balanced anti-tumor efficacy and hematologic safety of the 1mg/2mL single-vial specification;
Chinese domestic registration trials confirmed consistent therapeutic response and manageable adverse reaction spectrum for domestic late-stage breast and soft tissue sarcoma populations.
Common Side Effects
Common mild adverse reactions: Neutropenia, fatigue, alopecia, nausea, peripheral neuropathy and constipation;
Laboratory abnormalities: Transient grade 1–4 leukopenia, anemia and elevated liver transaminases;
Severe but uncommon risks: Severe febrile neutropenia, cumulative peripheral neuropathy, severe cardiac arrhythmia, hypersensitivity reactions and severe electrolyte disturbances.
Approval Status in China
Original drug Halaven® (Chinese brand: Hailewei) was officially approved for marketing in China in 2019, with the specification of 2mL:1mg per vial, 1 vial per box. It is currently a prescription anti-tumor chemotherapeutic agent included in China’s Category B medical insurance catalogue.
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