Boan Biotech today announced that patient enrollment has been completed for the Phase 3 clinical study (comparative clinical study of efficacy and safety) of BA9101 (Aflibercept Intravitreous Injection) ，which is an self-developed investigational ophthalmic drug in China. The clinical study is being conducted by Boan Biotech in collaboration with its partner Ocumension Therapeutics. (BA9101 is coded-named OT-702 at Ocumension Therapeutics)
Aflibercept is a homodimeric fusion protein consisting of portions of human vascular endothelial growth factor receptor (VEGFR) extracellular domains (VEGFR 1 Ig2 and VEGFR 2 Ig3) fused to the Fc portion of human IgG1. Aflibercept acts as a soluble decoy receptor that binds VEGF-A, VEGF-B and PlGF, and thereby can inhibit the binding and activation of endogenous VEGF receptor with VEGF-A and PlGF, so it can be used as the treatment for pathological neovascular ophthalmopathy of retina and choroid. EYLEA® was approved by FDA in 2011 and currently it was approved for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Retinopathy of Prematurity (ROP) worldwide. Aflibercept was approved in 2018 in China for the treatment of wAMD and DME.
BA9101 is a biosimilar to EYLEA® developed by Boan Biotech following the relevant research guidelines of biosimilars. The head-to-head pre-clinical study comparison of BA9101 to EYLEA® showed a high degree of similarity in both physiochemical properties and biological activities. The results of its phase 1 clinical study showed that BA9101 has a good safety and tolerability profile. Based on Guideline of Similarity Evaluation and Extrapolation of Biosimilar Medicinal Product issued by CDE, BA9101 can be approved for all approved indications of EYLEA® in China.
Retinal diseases including wAMD, DME, and RVO are often characterized by ocular exudate, hemorrhage, and fibrosis. These diseases are major causes of visual impairment and blindness worldwide. Due to population aging and other factors, the incidence of retinal diseases is going up. Aflibercept is widely used as a first-line treatment for wAMD, RVO, DME and DR. Driven by patient demand, the market is very promising for Aflibercept. According to data from IQVIA and publicly available information, the sales of EYLEA® in China and global were RMB 654 million and USD 9.65 billion in 2022 respectively.
To accelerate the clinical study and commercialization of BA9101, Boan Biotech entered into a collaboration and exclusive promotion agreement with Ocumension Therapeutics in October 2020, to jointly conduct the Phase 3 clinical study of BA9101 in China. Under the agreement, Ocumension Therapeutics is also granted the exclusive right to commercialize and market BA9101 in mainland China.
Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said, "Aflibercept, known as the king of ophthalmology, has many advantages. On the one hand, it can inhibit VEGF and PlGF at the same time, playing a dual role of anti-angiogenesis and anti-inflammation, which effectively improves the condition of patients with retinal edema and fundus diseases from three levels of cytokines, microstructure and vision. That’s why Aflibercept has been considered a first-line drug for the treatment of wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), Diabetic retinopathy (DR), etc.. On the other hand, Aflibercept is a long-acting agent and can inhibit the development of diseases. Boan Biotech has strong capabilities of new drug development and industrialization, while Ocumension Therapeutics has rich resources in the field of ophthalmology. The joint efforts of the two sides will accelerate the development and commercialization of BA9101, which will bring light to more patients with fundus vascular diseases in the future."
About Boan Biotech
As a subsidiary of Luye Pharma Group, Boan Biotech (6955.HK) is a fully-integrated biopharmaceutical company developing, manufacturing, and marketing biologics, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic diseases. The company discovers antibodies on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform, and ADC Technology Platform. The company’s portfolio currently includes two commercialized products, multiple investigational antibodies protected for their international intellectual property rights, and a number of biosimilar candidates.