BPM Secures Marketing Authorization in Brazil, Targeting Over $10 Billion Healthcare Opportunity

BPM Secures Marketing Authorization in Brazil, Targeting Over $10 Billion Healthcare Opportunity

Following the recent approval in Guatemala, Bio Preventive Medicine Co., Ltd. (hereinafter referred to as "BPM," TWSE code: 6810) announced that its self-developed innovative IVD reagent, DNlite-IVD103, has received marketing authorization from the Brazilian National Health Surveillance Agency (ANVISA). The indication for this approval is for the risk assessment of diabetic kidney disease (DKD) in patients with type 2 diabetes.

BPM stated that Brazil, being the largest economy in Latin America and the largest medical device market in South America, represents a highly competitive market with significant opportunities. The successful acquisition of marketing authorization in Brazil is therefore highly significant. Furthermore, DNlite-IVD103 is protected by patents in Brazil, which will help ensure technological leadership and accelerate market promotion. The company is currently planning to expand into the Latin American market through a joint distribution model and is in discussions with potential partners.

According to report from the International Diabetes Federation (IDF), there are approximately 15.73 million adults living with diabetes in Brazil, ranking sixth globally and first in Latin America for diabetes prevalence. In 2021, the Brazilian government invested up to $42.9 billion in diabetes-related medical expenses, highlighting a substantial healthcare opportunity.

DNlite-IVD103 is the world's first ELISA IVD reagent designed to prevent the rapid deterioration of diabetic kidney disease and has already received marketing approvals in the European Union, Taiwan, Malaysia, Thailand, Saudi Arabia, the United Arab Emirates, Vietnam, Indonesia, and Guatemala. Now, with the approval in Brazil, the largest country in South America, the global certification process is accelerating. The company is actively advancing business collaborations and distribution channels in various regions and countries. With the gradual benefits of a global multi-point layout, the company anticipates strong growth in performance and is optimistic about its operations in the coming year.