Boan Biotech’s Boyoujing^® Approved for Marketing in China for the Treatment of nAMD and DME

Boan Biotech today announced that its aflibercept intravitreous injection Boyoujing® has been approved by China’s National Medical Products Administration (NMPA) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults. Boan Biotech will work with Ocumension, a leading Chinese platform for ophthalmic drugs, to commercialize this product in the Chinese Mainland.
 

Aflibercept: A first-line treatment for multiple retinal diseases

Boyoujing is a biosimilar to EYLEA®. Its active ingredient is aflibercept, a humanized fusion protein binding 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 a durable efficacy as well as a favorable overall safety and tolerability profile.^1,2

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). In China, it has been approved for the treatment of nAMD and DME.

The development of Boyoujing followed regulatory guidelines for biosimilars, and 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. In a Phase I clinical trial, Boyoujing and the reference product (the originator drug) demonstrated a comparable safety and tolerability profile. In a Phase Ⅲ clinical trial, both Boyoujing and the reference product produced clinically meaningful improvements of the best-corrected visual acuity (BCVA) from the baseline as measured by the ETDRS chart at Weeks 4, 8, 12, 16, 20, and 24, and Boyoujing demonstrated high comparability to the reference product with a rapid onset of action and sustained efficacy, achieving all clinical endpoints.

Dr. Changlin Dou, President of R&D and Chief Operating Officer at Boan Biotech, said:“Aflibercept targets multiple pathways and delivers durable efficacy with a favorable safety profile. Boyoujing is the second biosimilar of EYLEA approved in China and our fifth product approved in the past five years. This has again demonstrated our strong R&D capabilities and our efficient, end-to-end integration from research to commercialization. Next, we will work closely with our partners to speed up the commercial availability of Boyoujing in the Chinese Mainland and drive its development in overseas markets, with the aim of providing a high-quality and affordable treatment option to patients around the world.”

Partnering to increase the availability of Boyoujing

Retinal diseases, including nAMD and DME, are serious eye conditions significantly compromising the health of patients and their quality of life. DME is a major complication of diabetes and one of the leading causes for vision loss in diabetic patients, affecting an estimated 5.2% of them.^1,3 In 2024, approximately 148 million adults aged 20–79 in China were living with diabetes.⁴ AMD is another leading cause for visual impairments and blindness in elderly people, affecting 20.2% of individuals over 70 years old in China.² Although nAMD accounts for only 10–20% of all AMD cases,² it is responsible for approximately 90% of the AMD-related blindness.⁵

A huge number of patients have led to the rapid growth of anti-angiogenic ophthalmic therapies in China. According to IQVIA, the size of the market for such therapies increased from RMB 1.27 billion in 2018 to RMB 4.99 billion in 2024, with a compound annual growth rate (CAGR) of 25.6%.

To accelerate patient access to Boyoujing, Boan Biotech entered into an agreement with Ocumension in 2020 to jointly conduct a Phase Ⅲ clinical trial of Boyoujing in China and granted Ocumension the exclusive right to promote and commercialize the product in the Chinese Mainland. As a leading platform for ophthalmic products in China, Ocumension is dedicated to building integrated capabilities across the lifecycle of ophthalmic medications, from R&D and manufacturing to commercialization. With a portfolio of 43 ophthalmic drugs under development and/or commercially available, the company has a sales and marketing team of several hundred professionals and a well-established commercial network covering over 20,000 hospitals nationwide.

Jiang Hua, Chief Executive Officer and Chairlady of Boan Biotech, said: “There are many patients affected by retinal diseases like nAMD and DME, and their unmet medical needs are pressing, Ocumension is a strategic partner of us with strong expertise in ophthalmology. We will leverage the strength of each other and adopt an efficient collaboration model to ensure the successful launch of Boyoujing, to make it accessible and affordable to patients, and to drive our long-term growth.”

Besides the Chinese market, Boan Biotech is also actively driving the development of Boyoujing abroad. The company has granted Kexing Risedo Pharm Co., Ltd., a wholly-owned subsidiary of Kexing Biopharm, the exclusive right to market and distribute Boyoujing in specified markets, which include all countries and regions other than the Chinese Mainland, the EU, the UK, the US, and Japan.