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◇◇ Mitigating Tariff Risks and Enhancing Trust through Local U.S. Production
According to industry sources on the 17th, Enterobiome began U.S. sales of its premium health functional food brand, FLOUREN, in mid-December. The product is powered by the next-generation microbiome Akkermansia muciniphila (hereinafter "Akkermansia") and is available through Amazon, the world’s largest e-commerce platform.
The decision to debut its first commercial product in the United States was driven by market scale, consumer accessibility, and the availability of local production facilities. According to the Korea Health Functional Food Association (as of 2022), the U.S. is the world’s largest market, accounting for $62.4 billion in sales and a 35.4% market share. It is followed by China ($25.11 billion, 14.3%) and India ($12.01 billion, 6.8%)—regions where Enterobiome plans to launch products sequentially.
By partnering with Amazon, Enterobiome has secured a critical distribution channel; industry data suggests nearly one-third of U.S. health supplement distribution occurs via the platform. Furthermore, the rising credibility of "K-Brands" has boosted the popularity of Korean products on Amazon, with 2023 sales of Korean health supplements in the U.S. estimated to exceed $100 million.
To navigate recent tariff pressures, Enterobiome opted for full local production in the U.S. By establishing a domestic manufacturing system, the company has not only lowered costs but also ensured transparency and safety in the manufacturing process, meeting stringent U.S. quality standards.
The company also completed rigorous regulatory preparations, obtaining Self-Affirmed GRAS (Generally Recognized As Safe) status earlier this year. GRAS is a U.S. FDA-mandated system for verifying the safety of new food ingredients, adjudicated by specialized panels of toxicology and risk assessment experts.
"The greatest competitiveness of FLOUREN lies in the combination of our proven strain technology and U.S.-based quality control," an Enterobiome official stated. "We aim to provide long-term health solutions based on scientific evidence rather than following short-term trends."
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◇◇ Building a Portfolio: Respiratory Health and Body Fat Reduction
The company’s confidence stems from the specific efficacy of Akkermansia. Known to inhabit the intestinal mucosa, this next-generation beneficial bacterium plays a vital role in maintaining a strong intestinal barrier—a key defense line against harmful external substances and a critical factor in immune balance.
However, Akkermansia is notoriously difficult to culture as it only grows in oxygen-free environments. Enterobiome has overcome this hurdle with its proprietary "High-Yield Cultivation Method for Fastidious Anaerobic Strains." This technology is already patented in seven major regions, including the U.S., Europe, China, and Japan. In South Korea, the ingredient was the first of its kind to receive "Individually Recognized Functional Ingredient" certification from the Ministry of Food and Drug Safety (MFDS).
According to a patent analysis by the Korea Intellectual Property Strategy Agency, Enterobiome ranks among the top global players, placing 2nd in Akkermansia patents and 1st in Faecalibacterium patents. Excluding academic and public institutions, the company’s patent portfolio is considered world-class.
Bolstered by existing pre-orders, Enterobiome expects to generate approximately 8 billion KRW in revenue next year from its respiratory-focused Akkermansia products alone. A domestic sales partnership with Dong-A Pharmaceutical scheduled for the first half of next year is expected to further drive performance.
The company’s roadmap involves commercializing its health supplement portfolio—covering respiratory health, body fat reduction, and blood sugar management—before pursuing technology transfers (Licensing-out) for its clinical-stage drug candidates. The most advanced pipeline is an atopic dermatitis treatment, which has received Phase 1 clinical trial approval from the MFDS.
"Following this launch of our gut health product, we will expand the FLOUREN lineup in stages," the official added. "We are particularly focused on upcoming products reflecting the 'Gut-Lung Axis' concept, which is gaining significant attention in the global healthcare market."
Enterobiome is currently undergoing a mock technical evaluation as part of its preparations for a KOSDAQ listing. The company plans to move forward with its IPO next year, supported by the revenue generated from its health functional food business.
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