BOAN BIOTECH(06955.HK): Aflibercept Intravitreal Injection Submitted for Marketing Approval in Brazil for Wet AMD and Diabetic Macular Edema
NewTimeSpace News: Boan Biotech (06955.HK) released a voluntary announcement on 5 August 2026. The Company has completed submission of the Marketing Authorization Application for aflibercept intravitreal injection (BA9101, BoYouJing®) to ANVISA (Brazilian Health Regulatory Agency), for the treatment of neovascular (wet) age‑related macular degeneration (nAMD) and diabetic macular edema (DME). BA9101 is a biosimilar of EYLEA®, which was approved for marketing in China in November 2025.
According to the Company, EYLEA posted global sales of USD5.321 billion in 2025, and Brazil’s pharmaceutical market stood at USD39 billion in 2024. In June 2025, the Company entered into an exclusive overseas licensing agreement with a wholly‑owned subsidiary of Sinovac Biotech, granting exclusive sales rights in all countries and regions excluding China, the EU, the United Kingdom, the United States and Japan. The manufacturing quality management system for BA9101 complies with standards of China, the United States and the EU. The Brazilian filing marks an important step toward serving patients worldwide.
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