China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has completed the enrollment of all subjects in a Phase III safety and efficacy comparison study for its in-house developed ophthalmology product BA9101, a biosimilar version of Bayer’s Eylea (aflibercept). The study is being jointly conducted by the company’s partner, Ocumension Therapeutics (HKG: 1477).
Background of Eylea and Market Context
Eylea, first approved in the United States in 2011, is commercially available worldwide for the treatment of neovascular (wet) age-related macular degeneration (wAMD), diabetic macular edema (DME), macular edema after retinal vein occlusion (RVO), diabetic retinopathy (DR), and retinopathy of prematurity (ROP). It was approved in China in 2018 for use in wAMD and DME and entered the National Reimbursement Drug List (NRDL) in 2019, covering AMD, DME, visual impairment caused by choroidal neovascularization (CNV), and macular edema secondary to RVO. This status was renewed in 2021.
Collaboration and Clinical Study
Boan Bio and Ocumension entered into a partnership in October 2020 to collaborate on the Phase III clinical study for BA9101 in China. Ocumension was also granted exclusive promotion and commercialization rights for the product in mainland China. The successful completion of subject enrollment marks a significant milestone in the development of BA9101, paving the way for further evaluation and potential market entry.
Significance of the Study
This Phase III study is crucial in establishing the safety and efficacy of BA9101 as a biosimilar to Eylea, potentially offering an alternative treatment option for patients with various ophthalmic conditions. The collaboration between Boan Bio and Ocumension underscores their commitment to advancing innovative ophthalmology treatments in the Chinese market.-Fineline Info & Tech
