Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has achieved a significant milestone with the completion of a Phase III clinical study for its proprietary ophthalmology product BA9101. This biosimilar version of Bayer’s Eylea (aflibercept) targets the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) and is expected to become the second biosimilar version of Eylea available in China, following the approval of Qilu Pharmaceutical Co., Ltd.’s aflibercept in December 2023.
BA9101 is an investigational long-acting GLP-1 receptor agonist with a demonstrated long metabolic half-life in vivo, indicating its potential for sustained efficacy and improved treatment safety. In the randomized, double-blinded, parallel-controlled, multi-center Phase III study, the best corrected visual acuity (BCVA) of nAMD patients treated with BA9101 and Eylea at 24 weeks showed clinically significant improvements compared to baseline, establishing equivalence between the two treatment groups.
The successful completion of the Phase III trial and the subsequent market approval filing position Boan Biotech to potentially commercialize BA9101, capitalizing on the substantial market opportunity presented by Eylea’s global sales, which reached $2.8 billion in 2023, according to Bayer’s financial report. This development also highlights Luye Pharma Group’s strategic focus on advancing therapies in high-demand areas such as cardio-renal-metabolic, immunology, neuroscience, and oncology.- Flcube.com
