Microbio Co.'s exclusive intestinal technology has received U.S. safety certification. On the 22nd, Microbio announced that its globally unique intestinal microbiome product, Symbiota, has been granted GRAS (Generally Recognized as Safe) Independent/Self-affirmed safety certification in accordance with U.S. FDA regulations.
Microbio explained that Symbiota is an intestinal microbiome developed using a variety of intestinal probiotics through its proprietary anaerobic symbiotic fermentation technology. Unlike probiotics, Symbiota is a postbiotic product, representing the metabolic essence of probiotics after symbiotic fermentation. The U.S. official safety certification will be a crucial strategy for Microbio's entry into the global market.
The GRAS certification for Symbiota covers a range of products, including fermented organic soybeans with various probiotics, yeast, or their strain mixtures, encompassing all of Microbio's exclusively developed microbiome products.
Microbio's currently approved and marketed products in Taiwan include the first oral new drug for chemotherapy, MS-20, as well as other products sold through Sun Organism like Prime Enzyme (原生漾酵酶), Qingtihu Young (清醍醐養生液), and Tian Chun Boo Young (田中寶養生液), which are all made using Symbiota technology with different strains. Additionally, products under development, such as TB90010 for improving diabetes and LT-17 for enhancing liver function, also utilize Symbiota technology.
According to the approved GRAS usage scope, Symbiota can be used in nutritional beverages, protein and nutrition powders, smoothies and cereal drinks, regular and diet sports and energy drinks, regular and diet soft drinks, fruit juice beverages (including unreconstituted powders), dairy beverages and milk alternatives, gelatin-based candies, ready-to-eat cereals, and cooked cereals. The usage amount can reach up to 20% in liquid form and up to 10% in powder form. It is suitable for people aged 1 to 110 years.
Microbio highlighted that the technology, products, and efficacy of Symbiota have obtained multiple patents in major countries globally. In response to various international regulations, Microbio will adopt diversified product launch strategies, including pharmaceuticals, medical devices, specialized dietary foods, health supplements, and general foods, to accelerate market entry.
Currently, Microbio is conducting clinical trials combining MS-20 with PD-1 for the treatment of metastatic non-small cell lung cancer. The GRAS safety certification will support the global launch of the product upon the completion of these clinical trials.
Resource (mandarin): 中天腸道技術獲美安全認證 將成全球布局重要策略
