Romiplate® is the commercial brand name of Romiplostim for Injection, a thrombopoietin receptor agonist developed by Kyowa Kirin. It binds to the thrombopoietin receptor on megakaryocytes, promoting megakaryocyte proliferation and maturation, thereby increasing platelet count.
Main Indications
Treatment of adult patients with chronic immune thrombocytopenia (ITP) who have insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Clinical Research
The global pivotal phase III trials demonstrated that romiplostim can effectively increase platelet counts and reduce bleeding episodes in adult chronic ITP patients;
Chinese phase III study confirmed consistent efficacy and safety profile in domestic ITP population;
Long-term extension studies showed sustained platelet response and manageable adverse events with prolonged treatment.
Common Side Effects
Severe but important risks: Thromboembolic events, bone marrow reticulin fibrosis, severe hypersensitivity reactions;
Common mild adverse reactions: Headache, myalgia, arthralgia, fatigue, dizziness and injection site discomfort.
Approval Status in China
Original drug Romiplate® (Romiplostim for Injection, specification:0.72mL) was officially approved for marketing in China in 2017. It is currently a prescription thrombopoietin receptor agonist.
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