BLA for Boan Biotech’s BA9101 (Aflibercept) Accepted in China

Boan Biotech announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for the company’s Aflibercept Intravitreous Injection (BA9101). This is a biosimilar to EYLEA^® intended for treating neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in adults.

Aflibercept: a first-line treatment for multiple retinal diseases

Aflibercept, a first-line treatment for multiple retinal diseases like nAMD and DME, is a fusion protein that consists of the extracellular domains of VEGF-R1 and VEGF-R2 fused to the Fc portion of human immunoglobulin G1. It has a strong affinity for all VEGF-A, VEGF-B, and PlGF isoforms, and is able to inhibit intravitreous VEGF for an extended period of time. This enables the drug to effectively improve vision with a lasting effect. In addition, aflibercept has good safety and tolerability¹.

The results of a Phase 1 clinical trial (safety and tolerability comparison study) of BA9101 showed that the safety and tolerability of BA9101 group were consistent and comparable with those of the original reference drug group. A Phase 3 clinical trial of BA9101 comparing its efficacy and safety versus the reference drug in treating nAMD met all the endpoints. The results showed that the Best Corrected Visual Acuity (BCVA) based on the ETDRS visual acuity test in both treatment groups significantly improved from the baseline at Weeks 4, 8, 12, 16, 20, and 24, indicating the high similarity of BA9101 to the reference drug in terms of efficacy. BA9101 also demonstrated a rapid onset and sustained efficacy in the study.

EYLEA has been approved for various ophthalmic indications worldwide, 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 in adults. According to the Guideline of Similarity Evaluation and Extrapolation of Biosimilar Medicinal Products issued by China’s CDE, BA9101 can obtain all the indications approved for EYLEA in China.

Access to treatment to be improved given the huge demand

Retinal diseases such as nAMD, DME, and RVO marked by intraocular fluid leakage, bleeding, and fibrotic scarring are the leading causes of vision impairment and blindness worldwide. nAMD and DME are more prevalent than other retinal diseases, primarily because of the population aging and a growing incidence of diabetes. The prevalence of retinal diseases will continue to grow with the increase of people’s screen time and the population aging.

The demand for anti-angiogenic ophthalmic medications in China is huge. The IQVIA data shows that the size of the market for such drugs in China was approximately RMB 3.868 billion in 2023, growing 24.5% from 2022; specifically, the sales of EYLEA in China were about RMB 838 million, growing 30.1% from 2022. According to publicly available information, the worldwide sales of EYLEA were USD 9.21 billion in 2023.

BA9101 is the second EYLEA biosimilar for which a BLA has been submitted in China. It is also the fifth biosimilar for which Boan Biotech has filed a BLA. The drug will help to improve the accessibility and affordability of treatments for patients in need. The acceptance of its BLA again underscored the company's strong CMC development and efficient R&D management capabilities. Boan Biotech partnered with Ocumension to drive the Phase 3 clinical trial of BA9101 in China, and granted the latter the exclusive rights to promote and commercialize the drug in the Chinese mainland. In this partnership, Boan Biotech can take advantage of Ocumension’s expertise and strength in ophthalmology to make BA9101 available to patients with retinal diseases faster. 

Dr. Dou Changlin, Chief Operating Officer and President of R&D at Boan Biotech, said:“As a biosimilar to EYLEA, the world's best-selling ophthalmic drug, BA9101 will benefit patients with multiple retinal diseases after it is launched. Next, we will work closely with the regulators in the review process, and with our partners to prepare for its commercialization. We look forward to the early approval of BA9101, which will not only expand our portfolio but also help more patients. At Boan Biotech, we do everything with the needs of patients in mind. We will leverage our strength across the industry’s value chain to stay ahead of the competition in product launch and address the urgent needs of patients faster.” 

Reference：
1. The consensus of Chinese experts on treating diabetic macular edema via the intravitreous injection of aflibercept (2021). Chin J Exp Ophthalmol, May 2021, Vol. 39, No. 5.