Xinhua News Agency report (reporter Zhang Xiulan) On January 15, Qilu Pharmaceutical announced that the ranibizumab injection (Rimmyrah) had received marketing approval from the European Medicines Agency (EMA), becoming the first ophthalmic biologic agent produced in China to "go global."
Ranibizumab is used to treat wet (neovascular) age-related macular degeneration, vision impairment caused by diabetic macular edema, diabetic retinopathy, and more. According to the "World Vision Report," age-related macular degeneration, diabetic macular edema, and retinal vein occlusion are common "culprits" leading to vision loss in patients. Ranibizumab injection is a recombinant anti-VEGF (vascular endothelial growth factor) humanized monoclonal antibody Fab fragment that targets and inhibits human vascular endothelial growth factor A (VEGF-A). It is the world's first approved anti-VEGF drug for ophthalmology. Ranibizumab can prevent the proliferation of vascular endothelial cells, the formation of new blood vessels, and vascular leakage by binding to and blocking VEGF receptors, and it can also promote the regression of existing new blood vessels.
The marketing authorization approval of Ranibizumab Injection by EMA marks the first international entry of Qilu Pharmaceutical's biologic products, as well as the first successful "export" of a domestically produced ophthalmic biologic agent in China. In addition, the marketing application of Ranibizumab Injection submitted by Qilu Pharmaceutical in January 2023 has been accepted by the Center for Drug Evaluation of the National Medical Products Administration and is currently under review. This is the first biosimilar application for this product in China, with the potential to become the first to be marketed in the country.
Proofread by Zhai Yongjun