Core Viewpoint - The approval of Boan 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] 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] - The global indications for EYLEA® include nAMD, DME, retinal vein occlusion (RVO) with 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 drug in quality, efficacy, safety, and immunogenicity, with Phase I and III clinical trials showing significant improvements in best-corrected visual acuity (BCVA) compared to the reference group [2] - The Phase III clinical trial results indicated that Bo Youjing® achieved clinically significant improvements in BCVA at multiple time points (4, 8, 12, 16, 20, and 24 weeks), meeting all study endpoints with rapid and sustained efficacy [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 capabilities in research, manufacturing, and commercialization, with a portfolio of 43 products and a professional commercial team covering over 20,000 hospitals nationwide [3] - The collaboration aims to enhance the market launch of Bo Youjing®, improve patient accessibility to medication, reduce treatment burdens, and create new growth opportunities for the company [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