March 29, 2024 Source: drugdu 197
Mabwell announced a supply and commercialization agreement with an Indian pharmaceutical company for 9MW0813 (aflibercept intraocular injection, Eylea® biosimilar). According to the agreement, the cooperative company has obtained the exclusive rights to import, produce, register, market and sell 9MW0813 in India, and has the right to obtain non-exclusive rights in 10 countries, including some countries in South Asia and Africa.
9MW0813 is a biosimilar of Eylea® and has completed phase III enrollment in clinical studies in China. Based on the principles of comparative and incremental development and comprehensive evaluation of drugs, pharmaceutical, non-clinical and clinical comparison results indicate that 9MW0813 is highly similar to the originator product in terms of quality, safety and effectiveness.
About 9MW0813
9MW0813 is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein, indicated for diabetic macular edema and neovascular (wet) age-related macular degeneration. 9MW0813 is a biosimilar of aflibercept (Eylea®). It is a fusion protein formed by recombining the extracellular region binding domains of VEGFR-1 and VEGFR-2 with the Fc segment of human immunoglobulin. It can be combined with VEGF-A and PlGF The bound soluble decoy receptor can inhibit the binding and activation of endogenous VEGF receptors to VEGF-A and PlGF.
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