Core Insights - Shandong Boan Biotechnology Co., Ltd. has received approval from the National Medical Products Administration of China for its self-developed product, Bo Youjing (Aflibercept intravitreal injection solution), to treat adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) [1][2] - Boan Biotechnology plans to commercialize the product in collaboration with leading domestic ophthalmic pharmaceutical company, Oculis [1] - The company is also pursuing international market opportunities, having granted exclusive sales rights to Shenzhen Kexing Pharmaceutical Co., Ltd. in specific regions outside of mainland China, the EU, the UK, the US, and Japan [1] Company Performance - Boan Biotechnology's Bo Youjing is the fifth product approved in the last five years, showcasing the company's strong technical capabilities and efficient transformation from R&D to commercialization [2] - The company is projected to achieve a revenue of 730 million yuan in 2024, representing a year-on-year growth of 17.5%, with a net profit of 73.19 million yuan, marking a significant increase of 190 million yuan and the first annual profit [2] - The company is also advancing its innovative antibody development, focusing on key products such as BA1302 (anti-CD228 ADC), PR201 (PD-1/IL-2), PR203 (TL1A/IL-23 bispecific), BA1106 (non-IL-2 blocking anti-CD25 antibody), BA1304 (EGFR/B7H3 ADC), and BA1301 (anti-Claudin18.2 ADC) [2]

Core Viewpoint - The approval of the company's self-developed product, Bo You Jing (Aflibercept intravitreal injection solution), by the National Medical Products Administration of China marks a significant milestone for the company, enabling it to treat age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults [1] Group 1: Product Approval and Market Impact - Bo You Jing has received official approval for use in treating nAMD and DME, which are prevalent eye diseases [1] - Following the announcement, the company's stock rose nearly 7% in early trading, indicating positive market sentiment [1] - The product is a biosimilar to EYLEA, with a broader target action compared to anti-VEGF monoclonal antibodies, enhancing its market potential [1] Group 2: Collaboration and Commercialization - The company will collaborate with a leading ophthalmic pharmaceutical platform, Eucan Vision, to commercialize Bo You Jing in mainland China [1] - The company has also authorized a subsidiary of Sinovac Biotech to exclusively sell the product in specific regions outside of China, the EU, the UK, the US, and Japan, indicating a strategic approach to global market expansion [1] Group 3: Product Characteristics and Efficacy - Bo You Jing's active ingredient, Aflibercept, is a humanized fusion protein that binds to VEGF-A, VEGF-B, and PlGF, providing a wider range of action [1] - The product is expected to have a long duration of effect in inhibiting intraocular VEGF, which can significantly improve vision and has good overall safety and tolerability [1]

Core Insights - The company, Boan Biotech, has received approval from the National Medical Products Administration of China for its self-developed product, Bo Youjing (Aflibercept intravitreal injection solution), marking the second new product approved this year [1] - Bo Youjing is a biosimilar to EYLEA, targeting various retinal diseases and demonstrating long-term efficacy and good safety profile [1] - The CEO of Boan Biotech highlighted the significant clinical value of Aflibercept and the growing demand for treatment of retinal diseases [2] Product Development - Boan Biotech has successfully launched five products in the past five years, all of which are biosimilars [2] - The company’s first product, Bo Youping, was approved in August as the first domestic Dula-glutide [1][2] Commercialization Strategy - Boan Biotech has partnered with Eucan Vision for commercialization, leveraging a team of hundreds in the ophthalmology field and a network covering over 20,000 hospitals nationwide [1] - The company has also granted exclusive sales rights for Bo Youjing to a subsidiary of Sinovac Biotech in specific regions [1] Financial Performance - For 2024, Boan Biotech projects revenue of 730 million yuan, a year-on-year increase of 17.5%, and a net profit of 73.19 million yuan, marking a turnaround with a profit increase of 190 million yuan [2] - The successful commercialization of new products like Bo Youping and Bo Youjing is expected to enhance the company's profitability and commercial capabilities [2]

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]

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]