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博安生物:阿柏西普眼内注射溶液博优景 在中国获批上市
Zhi Tong Cai Jing· 2025-11-26 11:31
Core Viewpoint - The company has received approval from the National Medical Products Administration of China for its self-developed product, Bo You Jing (Aflibercept Injection), to treat adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1] Group 1: Product Development and Approval - Bo You Jing is a biosimilar to EYLEA, with a broader target action compared to anti-VEGF monoclonal antibodies, effectively inhibiting intraocular VEGF and improving vision with long-term efficacy and good overall safety [1][2] - The development process of Bo You Jing strictly followed biosimilar guidelines, demonstrating high similarity in quality, efficacy, safety, and immunogenicity to the reference drug [2] Group 2: Market Demand and Growth - The market for anti-angiogenic drugs for eye diseases in China is rapidly growing, with a projected increase from RMB 1.27 billion in 2018 to RMB 4.99 billion by 2024, reflecting a compound annual growth rate of 25.6% [3] - The significant patient population affected by eye diseases such as DME and nAMD drives the demand for effective treatments, with an estimated 148 million adults aged 20 to 79 suffering from diabetes in China by 2024, and 5.2% of them having DME [2] Group 3: Strategic Partnerships and Commercialization - The company has partnered with leading ophthalmic pharmaceutical platform, OcuMedi, to commercialize Bo You Jing in mainland China, leveraging OcuMedi's extensive commercial network and expertise [3] - The collaboration aims to enhance patient access to the medication and reduce treatment burdens while creating new growth opportunities for the company [3]
博安生物(06955):阿柏西普眼内注射溶液博优景®在中国获批上市
智通财经网· 2025-11-26 09:51
Core Viewpoint - The company has received approval from the National Medical Products Administration of China for its self-developed product, Bo You Jing (Aflibercept intravitreal injection solution), to treat adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1] Group 1: Product Overview - Bo You Jing is a biosimilar to EYLEA, with the active ingredient Aflibercept, which binds to a broader range of targets compared to anti-VEGF monoclonal antibodies [1] - Aflibercept is an essential first-line treatment for various retinal diseases, effectively improving vision with long-lasting efficacy and good overall safety and tolerability [1] Group 2: Clinical Development - The development of Bo You Jing strictly followed biosimilar guidelines, demonstrating high similarity to the reference drug in quality, efficacy, safety, and immunogenicity [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 3: Market Potential - The market for anti-angiogenic drugs for eye diseases in China is rapidly growing, with a projected increase from RMB 1.27 billion in 2018 to RMB 4.99 billion by 2024, reflecting a compound annual growth rate of 25.6% [3] - The company has partnered with a leading ophthalmic pharmaceutical platform, Eucan Vision, to conduct Phase III clinical trials and grant exclusive commercialization rights in mainland China [3] Group 4: Patient Demographics - 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 [2] - Age-related macular degeneration (AMD) is a leading cause of vision loss in the elderly, with a prevalence of 20.2% in individuals over 70 years old in China [2]