Mailisheng® is the commercial brand name of Pegfilgrastim α for injection, a long-acting recombinant human granulocyte colony-stimulating factor developed by Qilu Pharmaceutical. It binds to receptors on myeloid progenitor cells, promotes their proliferation and differentiation, and accelerates neutrophil recovery after chemotherapy.
Main Indications
To decrease the incidence of febrile neutropenia in adult patients receiving myelosuppressive anticancer chemotherapy.
Clinical Research
Pivotal phase III clinical study demonstrated that pegfilgrastim α was non-inferior to reference pegfilgrastim in reducing the duration of severe neutropenia and the incidence of febrile neutropenia. A single subcutaneous injection per chemotherapy cycle can provide sustained neutrophil-stimulating effect, meeting the primary efficacy endpoint with acceptable safety.
Common Side Effects
Bone pain, myalgia, arthralgia;
Other common reactions: headache, fatigue, injection site reactions. Rare serious adverse events include splenic rupture, acute respiratory distress syndrome and severe allergic reactions.
Approval Status in China
Original drug Mailisheng® (Pegfilgrastim α for Injection) was officially approved for marketing in China in 2023, with the specification of 20mg per vial. It is currently a prescription drug.
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