Founded in 2017, HealthBiome is a researcher-initiated start-up from the Korea Research Institute of Bioscience and Biotechnology (KRIBB). It is headquartered in Daejeon with a GMP manufacturing facility in Jeonju.
Its Akkermansia muciniphila postbiotic ingredient, named HB05P, has completed the New Dietary Ingredient Notification (NDIN) process with the US FDA for the high-dose formulation (3.0×10¹⁰ cells/day).
This marks its second FDA NDI acknowledgment following the low-dose approval (1.0×10¹⁰ cells/day) received in December 2024, which was the world’s first NDI for the Akkermansia muciniphila strain (NDIN #1363).
On December 24, 2025, HB05P (high-dose formulation) was granted approval as a functional ingredient with the authorized health claim of “may help to maintain muscle strength which can be affected by aging” by South Korea’s Ministry of Food and Drug Safety (MFDS).
“This approval creates a strong first-mover advantage in Korea’s rapidly growing health functional foods market and establishes a regulatory barrier that competitors will need years to overcome” Dr Jay Lee, Chief Business Officer of HealthBiome, told NutraIngredients.
“Combined with our FDA NDI acknowledgment, this dual validation enables a command of premium pricing in both B2B and B2C markets.”
According to company CEO Byoung-Chan Kim, HB05P is now positioned for commercial launches in both markets starting from this year.
Unlike live forms fragile to harsh processing conditions, HB05P is flexible for all types of product format, such as capsule, tablet, liquid or gummy, as a postbiotic formulation.
Dr Lee revealed that the company is planning for capsules as the major product format, but does not rule out other options for the final product design.
Engine for growth
Korea’s health functional foods market is valued at over USD4 billion annually and growing at 8 to 10% per year, underscoring big commercial opportunities for science-backed functional ingredients.
For its go-to-market strategy, HealthBiome has an exclusive partnership with Samyang Foods, one of Korea’s leading food manufacturers, for the domestic market.
“For the US market, we are planning to launch our dietary supplement, and are currently evaluating strategic partnership opportunities with major distributors and brands. We are also exploring B2B supply agreements,” Dr Lee said.
HB05P is poised to become a robust growth driver for the company, as the US muscle health and senior nutrition market represents a “multi-billion dollar opportunity”, with the population aged 65 and above expected to nearly double to 80 million by 2040.
“Given HB05P’s unique positioning as the first FDA NDI-acknowledged Akkermansia muciniphila postbiotic with clinical evidence for muscle health, we believe we can capture significant market share in this rapidly expanding segment.”
Clinical evidence
HB05P is a postbiotic ingredient derived from Akkermansia muciniphila HB05, a beneficial bacterial strain originally isolated from the breast milk of healthy Korean mothers.
The ingredient utilizes a proprietary pasteurization process to create a heat-killed bacterial formulation that maintains functionality while markedly improving safety and stability compared to live probiotic products.
HealthBiome stated that the HB05P high-dose formulation has demonstrated statistically significant improvements in muscle strength through rigorous human clinical trials.
In a 12-week randomized, double-blind, placebo-controlled study involving 80 Korean adults aged between 60 and 80, the HB05P group showed significant increases in muscle strength over placebo group with p-values of 0.007-0.008 for primary endpoints; favorable changes in key biomarkers including increased IGF-1 and prealbumin, with decreased myostatin levels; and an excellent safety profile with no significant adverse events.
“We are registering our clinical study to Clinical Research Information Service (CRIS) of Republic of Korea, a primary registry for the WHO International Clinical Trials Registry Platform (ICTRP). The study is currently under manuscript preparation for submission to a peer-reviewed journal,” said Dr Lee.
