Workflow
博优景®(阿柏西普眼内注射溶液)
icon
Search documents
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
Ge Long Hui A P P· 2025-11-26 10:38
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: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 10:05
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 has a broader target action compared to anti-VEGF monoclonal antibodies, effectively inhibiting intraocular VEGF for a prolonged period [1][2] - The product has shown significant improvements in best-corrected visual acuity (BCVA) during clinical trials, demonstrating comparable efficacy and safety to the reference drug [2] Group 2: Market Potential - 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, with a compound annual growth rate (CAGR) of 25.6% [3] - The prevalence of DME among diabetic patients is approximately 5.2%, while age-related macular degeneration (AMD) affects 20.2% of individuals over 70 years old in China, indicating a significant patient population for Bo You Jing® [2] Group 3: Strategic Partnerships - The company has partnered with leading ophthalmic pharmaceutical platform, OcuVist, to commercialize Bo You Jing® in mainland China, leveraging OcuVist's extensive commercial network and expertise [3] - The collaboration aims to enhance patient accessibility to the drug and reduce treatment burdens while creating 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
Ge Long Hui· 2025-11-26 09:53
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]