BOAN BIOTECH (06955) announced that its self-developed Boyoujing® (aflibercept ophthalmic injection solution) has officially received marketing approval from China's National Medical Products Administration (NMPA). The drug is indicated for treating adults with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). The company will collaborate with China's leading ophthalmic pharmaceutical platform company, Ocumension Therapeutics, to commercialize the product in mainland China.
Boyoujing® is a biosimilar of EYLEA® (aflibercept), with its active ingredient being a humanized fusion protein. Compared to anti-VEGF monoclonal antibodies, it binds to vascular endothelial growth factors (VEGF-A, VEGF-B) and placental growth factor (PlGF), offering a broader mechanism of action. As a first-line treatment for nAMD, DME, and other retinal diseases, aflibercept provides prolonged VEGF suppression, effectively improving vision with long-term efficacy and favorable safety and tolerability.
Globally, EYLEA® has been approved for indications including nAMD, DME, macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR), myopic choroidal neovascularization (mCNV), and retinopathy of prematurity (ROP). In China, EYLEA® is approved for nAMD and DME.
Boyoujing®'s development strictly followed biosimilar guidelines, demonstrating comprehensive similarity to the reference product through pharmaceutical, non-clinical, and clinical studies. It shows high comparability in quality, efficacy, safety, and immunogenicity, with no clinically meaningful differences.
Phase I clinical trials confirmed Boyoujing®'s comparable safety and tolerability to the reference drug. Phase III trials showed clinically significant improvements in best-corrected visual acuity (BCVA) at weeks 4, 8, 12, 16, 20, and 24, meeting all endpoints with rapid and sustained efficacy.
Retinal diseases like nAMD and DME are severe blinding conditions significantly impacting patients' lives. DME, a major complication of diabetes, is a leading cause of vision impairment. In 2024, China had approximately 148 million diabetic adults aged 20–79, with 5.2% suffering from DME. Age-related macular degeneration (AMD) is another leading cause of vision loss in the elderly, affecting 20.2% of those over 70 in China. nAMD accounts for 10%–20% of AMD cases but contributes to 90% of AMD-related blindness.
Growing patient demand has driven rapid expansion in the ocular anti-angiogenic drug market. IQVIA data shows China's market grew from RMB 1.27 billion in 2018 to RMB 4.99 billion in 2024, with a 25.6% CAGR.
To accelerate patient access, BOAN BIOTECH partnered with Ocumension Therapeutics in 2020 for Phase III trials and granted exclusive commercialization rights in mainland China. Ocumension, with 43 ophthalmic products in development or marketed, a specialized commercial team, and a nationwide hospital network, will collaborate to enhance patient accessibility and reduce treatment burdens while expanding BOAN BIOTECH's growth potential.
Beyond China, BOAN BIOTECH is advancing Boyoujing®'s global rollout, having authorized Sinovac Biotech's subsidiary Shenzhen Sinovac Pharmaceutical for exclusive sales in regions excluding mainland China, the EU, UK, US, and Japan.
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