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Today(August 19), the official website of China's National Medical Products Administration (NMPA) announced that the marketing application for Qilu Pharmaceutical's biosimilar of ranibizumab, submitted under the biologics category 3.3, has been officially approved.. Public information shows,Ranibizumab Injection is a recombinant anti-vascular endothelial growth factor (VEGF) Humanized monoclonal antibody Fab fragment,Product Indications Include:Neovascular (wet) age-related macular degeneration (AMD), vision impairment caused by diabetic macular edema, diabetic retinopathy, vision impairment caused by macular edema secondary to retinal vein occlusion, vision impairment caused by choroidal neovascularization, and retinopathy of prematurity.
Screenshot source:NMPA Official Website
Ranibizumab can specifically inhibit human vascular endothelial growth factor A (VEGF-A) by binding to and blocking VEGF receptors, thereby preventing the proliferation of vascular endothelial cells, new blood vessel formation, and vascular leakage, while also promoting the regression of existing new blood vessels.RanibizumabOriginal product Lucentis (Lucentis)Have been approved for multiple indications in China, including wet age-related macular degeneration, diabetic macular edema, macular edema secondary to retinal vein occlusion, choroidal neovascularization, diabetic retinopathy, and retinopathy of prematurity, among others.According to the introduction in the earlier press release,Qilu Pharmaceutical Co., Ltd.The development of Ranibizumab Injection was initiated in 2012.Researchers established a robust production process through small-scale, pilot-scale, and commercial-scale manufacturing. In strict accordance with biosimilar standards, they conducted a comprehensive quality analysis of the product’s structure, physicochemical properties, and biological activity. The results confirmed its similarity to the originator drug.Clinical trial results also show that the product is basically consistent with the original drug in terms of safety and efficacy.
According to the China Drug Clinical Trial Registry and Information Disclosure Platform, Qilu Pharmaceutical has completed two clinical trials of QL1205.One of them is randomized, double-blind, parallel two-group, positive control,International Multicenter Phase 3 Clinical TrialAimed to compare the safety and efficacy of QL1205 with the original product in patients with neovascular age-related macular degeneration.Another is randomized, double-blind, parallel, positive controlPhase 1 Clinical TrialAim to compare the safety, pharmacokinetics, and pharmacodynamics of QL1205 and the original product in patients with wet age-related macular degeneration.
[1]Drug Approval Certificate Delivery Information on August 19, 2024. Retrieved Aug 19, 2024, fromhttps://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240819150923195.html[2] Qilu Pharmaceutical's Ranibizumab Injection Marketing Application Accepted. Retrieved Jan 30, 2023, from https://mp.weixin.qq.com/s/auR3UCRlUHEZ00msmKFMjQThis article comes fromCompiled and edited by the WuXi AppTec content team based on publicly available information. Feel free to share with your personal WeChat Moments. For authorization to repost or other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.
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