Core Viewpoint - The approval of Boao Bio's product, Bo Youjing® (Aflibercept intravitreal injection solution), by the National Medical Products Administration of China marks a significant advancement in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults, with plans for commercialization in collaboration with a leading ophthalmic pharmaceutical platform, EOCON Vision [1][3]. Group 1 - Bo Youjing® is a biosimilar to EYLEA®, with its active ingredient Aflibercept being a humanized fusion protein that targets a broader range of factors compared to anti-VEGF monoclonal antibodies, effectively inhibiting intraocular VEGF and improving vision with long-term efficacy and good overall safety [1][2]. - EYLEA® has been approved globally for multiple indications, including nAMD, DME, retinal vein occlusion (RVO) related macular edema, diabetic retinopathy (DR), myopic choroidal neovascularization (mCNV), and retinopathy of prematurity (ROP), while in China, it is approved for nAMD and DME [1]. Group 2 - The development of Bo Youjing® adhered strictly to biosimilar guidelines, demonstrating high similarity to the reference product in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences [2]. - Phase I clinical trial results indicated comparable safety and tolerability between Bo Youjing® and the reference product, while Phase III trials showed significant improvements in best-corrected visual acuity (BCVA) at multiple time points, achieving all study endpoints [2]. Group 3 - To expedite the availability of Bo Youjing® to more patients, the company partnered with EOCON Vision in 2020 to conduct Phase III clinical trials and granted EOCON exclusive promotion and commercialization rights in mainland China [3]. - EOCON Vision, as a leading ophthalmic pharmaceutical platform, focuses on integrated development capabilities in research, manufacturing, and commercialization, with a portfolio of 43 products and a professional commercial team covering over 20,000 hospitals nationwide [3].
博安生物(06955.HK)：阿柏西普眼内注射溶液博优景在中国获批上市