Core Viewpoint - The company has received approval from the National Medical Products Administration of China for its self-developed drug, Bo You Jing (Aflibercept intravitreal injection solution), to treat adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1][2] Group 1: Product Development and Approval - Bo You Jing is a biosimilar to EYLEA, with its active ingredient Aflibercept being a humanized fusion protein that binds to VEGF-A, VEGF-B, and PlGF, offering a broader target compared to anti-VEGF monoclonal antibodies [1][2] - The development process of Bo You Jing strictly followed biosimilar guidelines, demonstrating high similarity in quality, efficacy, safety, and immunogenicity with the reference drug [2] - Phase I clinical trial results showed comparable safety and tolerability between Bo You Jing and the reference drug, while Phase III trials indicated significant improvements in best-corrected visual acuity (BCVA) at multiple time points [2] Group 2: Market Potential and Patient Demographics - Eye diseases, including nAMD and DME, are significant causes of blindness, with DME being a major complication of diabetes affecting vision [3] - In 2024, approximately 148 million adults aged 20 to 79 in China are expected to have diabetes, with 5.2% of them suffering from DME; the prevalence of nAMD among the elderly population over 70 is 20.2% [3] - The market for anti-angiogenic eye drugs in China is projected to grow from RMB 1.27 billion in 2018 to RMB 4.99 billion by 2024, reflecting a compound annual growth rate of 25.6% [3] Group 3: Strategic Partnerships and Commercialization - The company has partnered with leading ophthalmic pharmaceutical platform, OcuVision, to jointly conduct Phase III clinical trials and grant exclusive commercialization rights for Bo You Jing in mainland China [4] - OcuVision has a comprehensive capability in the full-cycle development of ophthalmic drugs, with a portfolio of 43 products and a commercial network covering over 20,000 hospitals nationwide [4] - The company is also pursuing international expansion for Bo You Jing, having authorized a subsidiary of Sinovac Biotech for exclusive sales in specific regions outside of China, the EU, the UK, the US, and Japan [4]
博安生物：阿柏西普眼内注射溶液博优景在中国获批上市