Kyprolis® is the official global commercial brand name, and Kailuosi is its Chinese brand name co-developed by Amgen and BeiGene. It is an irreversible selective proteasome inhibitor for intravenous infusion. It binds irreversibly to the 20S proteasome, blocking degradation of pro-apoptotic proteins and inducing death of malignant plasma cells in multiple myeloma.
Main Indications
Combined with lenalidomide and dexamethasone for relapsed/refractory multiple myeloma adult patients who have received 1 to 3 prior lines of therapy;
Combined with daratumumab and dexamethasone for relapsed/refractory multiple myeloma adult patients with 1 to 3 previous treatment regimens;
Monotherapy for relapsed/refractory multiple myeloma patients who have received at least two prior treatments including bortezomib and an immunomodulatory agent.
Clinical Research
Global multicenter phase III ASPIRE pivotal trial fully validated significant progression-free survival benefit of carfilzomib-lenalidomide-dexamethasone versus lenalidomide-dexamethasone alone for relapsed myeloma;
Head-to-head phase III ENDEAVOR trial confirmed superior overall survival compared with bortezomib-based salvage regimens for previously treated multiple myeloma;
Long-term open-label extension cohorts demonstrated sustained deep tumor remission under weekly or twice-weekly intravenous dosing cycles;
Dose-finding research verified balanced anti-myeloma efficacy and cardiovascular safety profile of the 60mg single-vial specification;
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: Fatigue, anemia, nausea, thrombocytopenia, dyspnea and diarrhea;
Laboratory abnormalities: Transient grade 1–4 neutropenia, decreased hemoglobin, elevated creatinine and liver enzyme fluctuations;
Severe but uncommon risks: Severe cardiac adverse events, acute renal injury, pulmonary hypertension, tumor lysis syndrome and severe infusion hypersensitivity reactions.
Approval Status in China
Original drug Kyprolis® (Chinese brand: Kailuosi) was officially approved for marketing in China in 2021, with the specification of 60mg per vial, 1 vial per box. It is currently a prescription proteasome inhibitor anti-myeloma drug included in China’s Category B medical insurance catalogue.
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