BOAN BIOTECH (06955): The Abicipar intravitreal injection solution has submitted a marketing authorization application in Brazil.

BOAN BIOTECH (06955) announced that the marketing authorization application for the company's Abicipar intraocular injection solution (BA9101) has been submitted to the Brazilian National Health Surveillance Agency (ANVISA). This product is intended for the treatment of adult neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). BA9101 is a biosimilar to EYLEA and was approved for sale in China in November 2025 (Chinese brand name: ). As one of the key products in the company's global development strategy, the overseas expansion of BA9101 is accelerating. In June 2025, the company signed an exclusive licensing cooperation agreement for overseas markets with Kexing Biopharms wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., granting the latter exclusive rights to sell BA9101 in all countries and regions except for mainland China, the European Union, the United Kingdom, the United States, and Japan. Currently, the registration and marketing of this product in relevant regions are progressing according to plan. Based on extensive patient demand and clear efficacy, BA9101 presents a broad market outlook: the scale of the Brazilian pharmaceutical market is projected to reach $39 billion in 2024, with a compound annual growth rate (CAGR) of 9% expected from 2025 to 2029; the global sales of EYLEA are projected to reach $5.321 billion in 2025. The company believes that Brazil, as one of the top ten pharmaceutical markets globally and the largest in Latin America, serves as a strategic hub for pharmaceutical companies to establish a presence in emerging markets. The submission of the marketing authorization application in Brazil is an important step in the process of supplying BA9101 to patients worldwide. The company will work with outstanding partners to promote the declaration and marketing of BA9101 in more countries, enhancing the accessibility of high-quality domestic biological drugs for patients with retinal diseases and opening new avenues for company growth.