Polivy® is the official global commercial brand name, and Youluohua is its Chinese brand name developed by Roche. It is a CD79b-targeted antibody-drug conjugate (ADC). It consists of humanized anti-CD79b monoclonal antibody linked to cytotoxic monomethyl auristatin E (MMAE); after binding CD79b on malignant B cells, it releases MMAE intracellularly to block microtubule polymerization and induce lymphoma cell apoptosis.
Main Indications
Combined with rituximab, cyclophosphamide, doxorubicin and prednisone (Pola-R-CHP) for adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL) with intermediate or high risk;
Combined with bendamustine and rituximab (Pola-BR) for relapsed/refractory DLBCL adult patients ineligible for autologous hematopoietic stem cell transplantation after at least two prior treatment lines;
Combined with rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx) for relapsed/refractory DLBCL adult patients unsuitable for stem cell transplantation.
Clinical Research
Global multicenter phase III POLARIX pivotal trial fully validated significant long-term progression-free survival benefit of Pola-R-CHP versus traditional R-CHOP for first-line high-risk DLBCL;
Global phase II GO29365 controlled trial confirmed durable deep remission and overall survival improvement of Pola-BR regimen for multi-line pretreated refractory DLBCL;
Chinese domestic POLAROSE registration trial verified consistent anti-tumor response and safety profile in local relapsed/refractory DLBCL patient population;
Phase III POLARGO trial supported approval of Pola-R-GemOx, showing remarkable reduction of disease progression and death risk for salvage therapy;
Dose-finding research confirmed balanced anti-lymphoma efficacy and peripheral neuropathy risk control under the standard 1.8 mg/kg intravenous dose every 21 days.
Common Side Effects
Common mild adverse reactions: Peripheral neuropathy, fatigue, diarrhea, fever, nausea and neutropenia;
Laboratory abnormalities: Transient thrombocytopenia, leukopenia and decreased hemoglobin;
Severe but uncommon risks: Grade 3–4 cumulative peripheral neuropathy, severe myelosuppression, severe infusion-related hypersensitivity, opportunistic infections and tumor lysis syndrome.
Approval Status in China
Original drug Polivy® (Chinese brand: Youluohua) was officially approved for marketing in China in January 2023, with the specification of 30mg per vial, 1 vial per box. It is a prescription CD79b-targeted ADC anti-lymphoma drug included in China’s Category B medical insurance catalogue.
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