Expanding the ASEAN Footprint: BPM Secures Regulatory Approval in Indonesia for DNlite-IVD103

Bio Preventive Medicine Corp. ("BPM", Stock Code: 6810) announced on May 13, 2024, that its proprietary innovative in vitro diagnostic (IVD) test, DNlite-IVD103, has been granted marketing authorization by the Ministry of Health (MOH) of Indonesia. The approved indication is for the risk assessment and prediction of Diabetic Kidney Disease (DKD) in patients with Type 2 diabetes. This milestone makes DNlite-IVD103 the first innovative biomarker IVD product from Taiwan to successfully penetrate the Indonesian market.

A Massive Unmet Need in the World's Fourth-Most Populous Nation 

With a total population of 270 million, Indonesia ranks fourth globally. According to reports from the Indonesian Ministry of Health, the diabetic population reached 19.5 million in 2021, marking a prevalence rate of 10.6% and ranking fifth worldwide. Driven by a dietary culture heavily reliant on rice and a preference for sweets, coupled with a general lack of health education, diabetes was once the fourth leading cause of death in Indonesia, trailing only stroke, heart disease, and cancer. Data from the International Diabetes Federation (IDF) reveals that the Indonesian government's diabetes-related healthcare expenditures soared to $6.3 billion USD in 2021, underscoring a colossal underlying market for precision medical services and diagnostics.     

Completing the ASEAN Strategic Puzzle 

Dr. Karen Tseng, Chairman and CEO of BPM, stated that following the recent regulatory approval in Vietnam, securing this medical device license in Indonesia—alongside prior approvals in Malaysia and Thailand—further solidifies and perfects the company's comprehensive layout in Southeast Asia. This year, in addition to accelerating the establishment of distribution channels across these regions, BPM is strategically aligning with the Taiwanese government's "New Southbound Policy" by actively exploring collaborative opportunities with major domestic hospitals. Through this multi-pronged approach, BPM is well-positioned to capture the massive healthcare market opportunities in Southeast Asia.     

Riding the Wave of "Medical-Led Business" Policy 

Dr. Tseng pointed out that, benefiting from the recent relaxation of corporate medical investment restrictions, Taiwanese hospitals have been rapidly establishing strongholds across Southeast Asia. Furthermore, government policies actively encourage robust exchanges with New Southbound countries, targeting seven priority nations—Vietnam, Malaysia, Indonesia, Thailand, the Philippines, India, and Myanmar—under the "One Country, One Center" (一國一中心) initiative. The goal is to integrate domestic pharmaceutical and medical device resources to jointly expand regional healthcare opportunities through a "Healthcare Driving Commerce" (以醫帶商) strategy. Having successfully obtained medical device marketing authorizations in four of these key nations (Vietnam, Malaysia, Indonesia, and Thailand), DNlite-IVD103 has secured the essential admission tickets to dominate the New Southbound healthcare market.

Future Outlook: Shaping Global Clinical Guidelines 

Looking ahead, Dr. Tseng emphasized that BPM will not only continue to advance regulatory applications for DNlite-IVD103's multiple indications (DKD and Kidney Transplant) in other global regions but will also accelerate the construction of distribution networks and fully drive sales performance in markets where approvals are already secured. The company will actively collaborate with Key Opinion Leaders (KOLs) in these countries and participate in their national-level healthcare programs. BPM's ultimate goal is to expand DNlite-IVD103's influence in DKD clinical care and treatment guidelines, realizing the vision of establishing DNlite as a paradigm for global medical guidelines.

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