Boan Biotech Submits BLA for Aflibercept Intravitreous Injection in Brazil

Boan Biotech announced today that it has submitted a Biologics License Application (BLA) to the Brazilian Health Regulatory Agency (ANVISA) for the company’s Aflibercept Intravitreous Injection (BA9101), intended for the treatment of neovascular(wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults.

BA9101, a biosimilar to EYLEA®, was approved for marketing in China in November 2025 and is marketed under the trade name Boyoujing®. As one of Boan Biotech’s key products under its global strategy, BA9101 is being developed across international markets. In June 2025, the company partnered with Kexing Risedo Pharm Co., Ltd., a wholly-owned subsidiary of Kexing Biopharm, granting the latter the exclusive rights to commercialize BA9101 globally (excluding the Chinese mainland, the EU, the UK, the U.S., and Japan). Currently, regulatory submissions and commercial launches are progressing on schedule across targeted territories.

Globally, EYLEA has been approved for various ophthalmic indications, including nAMD, DME, macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR), visual impairment due to myopic choroidal neovascularization (mCNV), and retinopathy of prematurity (ROP). Retinal diseases like nAMD and DME are the leading causes of vision impairment and blindness worldwide. With increasing screen time and an aging population, the prevalence of these conditions is expected to continue rising.

Aflibercept, the active ingredient of EYLEA, is a humanized fusion protein that binds with vascular endothelial growth factors (VEGF-A and VEGF-B) and placental growth factor (PlGF) to reach more targets than anti-VEGF monoclonal antibodies. As a first-line treatment for nAMD, DME, and several other retinal diseases, aflibercept sustainably inhibits intraocular VEGFs to effectively improve visual acuity with durable efficacy as well as a favorable overall safety and tolerability profile.¹

The development of BA9101 followed regulatory guidelines for biosimilars across China, the U.S., and the EU. Its similarity to EYLEA was established through a series of analytical, non-clinical, and clinical studies. The two products were shown to be highly similar in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences.

Furthermore, the manufacturing and quality control of BA9101 also follow international standards. Boan Biotech’s manufacturing facility was designed and built to state-of-the-art specifications, and the production processes are continuously refined and upgraded. The company has established a quality management system that complies with Chinese, the U.S. and EU standards, ensuring the quality of BA9101 and future products for overseas markets.

Substantial unmet medical needs and robust clinical efficacy underpin the commercial potential of BA9101. The pharmaceutical market in Brazil reached USD 39 billion in 2024. Projections anticipate a Compound Annual Growth Rate (CAGR) of 9% from 2025 to 2029.² Concurrently, the reference product EYLEA recorded global sales of USD 5.321 billion in 2025.³

Jiang Hua, Chairlady and Chief Executive Officer at Boan Biotech, said:“Brazil ranks among the top ten global pharmaceutical markets and leads Latin America.2 Consequently, the country serves as a strategic hub for emerging market expansion. This BLA submission in Brazil represents an important step in bringing BA9101 to patients worldwide. Moving forward, we will work closely with leading partners to advance the registration and commercialization of BA9101 in other countries, enhancing patient access to premium Chinese biologics for individuals with retinal diseases while establishing a new growth driver for us.”