News | April 8, 2024

Boan Biotech Completes Phase 3 Clinical Trial For Its Aflibercept Intravitreous Injection BA9101 In China, Planning To File A BLA

Boan Biotech today announced that a Phase 3 clinical trial (a comparative study of efficacy and safety) for its Aflibercept Intravitreous Injection (BA9101) in China has been completed. The company plans to submit a Biologics License Application (BLA) for the drug. BA9101 is a biosimilar to EYLEA® for the treatment of adults with neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in China.

Aflibercept: a first-line treatment for multiple retinal diseases
Aflibercept is a fusion protein of human Fc and certain extracellular domains of VEGF receptors R1 and R with the ability to bind VEGF-A, VEGF-B and P1GF isoforms. Compared with monoclonal antibodies, it has higher affinity for VEGF isoforms and a longer duration of intravitreous VEGF inhibition, which can effectively improve vision with a long-term efficacy as well as good safety and tolerability1.

The reference product EYLEA has been approved for multiple ophthalmic indications worldwide, including nAMD, DME, Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Retinopathy (DR), Visual Impairment due to Myopic Choroidal Neovascularisation (mCNV) and Retinopathy of Prematurity (ROP). In China, this drug has been approved for the treatment of adults with nAMD and DME.

The development of BA9101 followed the relevant research guidelines for biosimilars. The analytical and non-clinical comparability studies 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. The Phase 3 clinical trial was a randomized, double-blind, parallel-controlled, and multicenter clinical trial designed to compare the efficacy and safety of BA9101 versus EYLEA for the treatment of nAMD. The results of the study showed that the Best Corrected Visual Acuity (BCVA) in both groups during the 24 weeks of treatment demonstrated a clinically significant improvement from the baseline as proved by the ETDRS visual acuity test, indicating that BA9101 was equivalent to EYLEA in terms of efficacy. Based on the Guideline of Similarity Evaluation and Extrapolation of Biosimilar Medicinal Product issued by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), Boan Biotech will be able to submit an application for BA9101 to the CDE for all the indications approved for EYLEA in China.

Access to treatment to be improved given the huge demand
Various retinal diseases such as nAMD and DME are the leading causes of vision impairment and blindness, resulting in tremendous physical and mental sufferings of patients. Due to population aging and other factors, the number of patients with such diseases is constantly increasing, and the demand for ophthalmic drugs is also growing as a result.

Aflibercept is widely used as a first-line treatment for nAMD, DME, RVO, DR, mCNV and ROP, and the future market is promising driven by the demand in clinical practice. According to data from the IQVIA and the publicly available information, the sales of EYLEA in China and worldwide were RMB 838 million and USD 9.22 billion in 2023 respectively.

To accelerate the clinical trials and commercialization of BA9101, Boan Biotech entered into an agreement with Ocumension in October 2020, to jointly conduct the Phase 3 clinical trial of BA9101 in China. Under the agreement, Ocumension was also granted the exclusive right to commercialize and market BA9101 in mainland China. 

Dr. Dou Changlin, Chief Operating Officer and President of R&D at Boan Biotech, said: “As the fifth biosimilar developed by Boan Biotech, BA9101 will enable more patients with retinal diseases such as nAMD and DME to get access to timely, effective, and more affordable treatments. BA9101 is ahead of most other aflibercept biosimilars in terms of clinical development in China. We will continue to work closely with Ocumension to speed up the commercialization of BA9101 by leveraging our strength in R&D and their expertise in commercializing ophthalmics, so that patients with retinal diseases can benefit from this drug as soon as possible.”

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.

Source: Shandong Boan Biotechnology Co., Ltd