BPM's DNlite-IVD103 Obtains Market Approval in Singapore

Bio Preventive Medicine, BPM's DNlite-IVD103 Obtains Market Approval in Singapore—Another Victory in the ASEAN Market!

Bio Preventive Medicine Co., Ltd. (hereinafter referred to as "BPM," stock code: 6810) announced today that its self-developed innovative prognosis IVD reagent, DNlite-IVD103, has officially obtained verification registration approval from the Health Sciences Authority (HSA) in Singapore, indicated for the risk assessment of kidney disease (DKD) in type 2 diabetes patients.

CEO, Tseng Tzu-Ling noted that Singapore has the highest global rate of chronic kidney failure due to diabetes, and with the Singapore government leading the way in promoting and adopting innovative healthcare in ASEAN, the recent approval for DNlite-IVD103—following its authorization in Malaysia, Thailand, Vietnam, and Indonesia—signifies a positive indicator for accelerating entry into the ASEAN market.

Statistics show that Singapore is one of the developed countries with the highest prevalence of diabetes, with one in nine people affected. Additionally, the proportion of end-stage renal disease (ERSD) caused by DKD reaches 70%, the highest globally. With an aging population and rising diabetes rates, the incidence of advanced chronic kidney disease continues to increase, posing a significant healthcare burden on individuals and society.

A study from the National University of Singapore's Saw Swee Hock School of Public Health predicts that by 2050, the number of adult diabetes patients in Singapore will reach one million, a growth of over 40% since 2021, with annual economic costs amounting to $1.867 billion—a considerable burden. Consequently, Singapore is one of the most proactive countries in managing diabetes and chronic kidney disease. Since 2016, the government has initiated a series of prevention and health programs, becoming the first country in the world to ban advertisements for high-sugar packaged drinks and implementing mandatory nutritional labeling for all packaged beverages sold locally to reduce sugar intake.

Dr. Tseng further stated that given the increasing cases of end-stage kidney disease due to rising diabetes rates, the local medical community has even referred to this situation as "Singapore facing a CKD tsunami." This underscores the importance of collaborative management and prevention of diabetic kidney disease, presenting an opportunity for DNlite-IVD103 to expand in the local market. The company plans to actively develop marketing channels and hopes to gradually enter the government healthcare subsidy system with the assistance of distributors, making DNlite-IVD103 a part of medical teaching guidelines and eventually a routine testing item. Additionally, BPM will continue to seek regulatory certification for DNlite-IVD103 in other ASEAN countries to broaden and deepen its market presence.