AKK AM06 obtains US GRAS certification

On December 24, the new generation of probiotics AKK AM06? strain with independent intellectual property rights of Zhiyi Bio/Puwei Junjian, represented by TECH-INNO Health, obtained the Self-affirmed GRAS certification from the US Expert Committee, marking that the AKK AM06? strain has been officially included in the world's authoritative recognized safety list.

As early as August this year, the two parties have jointly established the "Guangdong Live Biopharmaceutical Engineering Technology Research Center-Second Generation Probiotics Innovative Food Collaborative R&D Center" to actively cooperate on projects such as "Innovative Research and Development of Second Generation Probiotic New Food Raw Materials and Products" and "Functional Food Screening and Evaluation Research". In the future, the two parties will continue to have in-depth exchanges and discussions on the research, development and application of AKK AM06?, and provide consumers with more and better second-generation probiotic products.

As the only exclusive distributor of AKK AM06? strains in the world, TECH-INNO Health also looks forward to working together with domestic and foreign partners to jointly promote the comprehensive development of this probiotic and bring safer and more effective probiotic health solutions to global consumers.

About GRAS certification

The FDA is authorized by the U.S. Congress, i.e. the federal government, and is the highest law enforcement agency specializing in food and drug management. GRAS, the abbreviation for "Generally Recognized As Safe", is the FDA's generally recognized safety (GRAS) scientific evaluation, which requires a rigorous scientific evaluation and review process. The GRAS certification standard is extremely strict, covering a number of key links such as the source of raw materials, production process, and quality control of the product. The successful GRAS certification of the AKK AM06? strain fully proves that the product has met international standards in terms of safety, compliance, and quality. This is a strong signal of trust, which means that AKK AM06TM has passed the review of one of the world's most stringent food safety regulatory agencies, ensuring the safety of consumers during use.

AKK is known as a model of the next generation of probiotics and one of the most promising new generation probiotics in the international market

AKK is the abbreviation of Akkermansia muciniphila, which was isolated from healthy human feces by Professor Willem M. de Vos' team in 2004. AKK bacteria account for 1-5% of the human microbiome. They are resident bacteria in the human intestine, colonize in the intestinal mucus layer, and feed on intestinal mucin. The abundance of AKK bacteria in the intestine is related to the host's age, diet, and health status, and the abundance is generally low in the Chinese population. A large number of studies have shown that AKK bacteria have significant effects in regulating the intestinal barrier, weight management, lowering blood sugar, and anti-aging, and inactivated AKK bacteria have the same biological effects as live bacteria, or even better than live bacteria.

AKK AM06? bacteria is currently the only AKK bacteria derived from breast milk, with high safety

Studies have shown that probiotics in breast milk can be transferred to the infant's intestine through the oral-intestinal-mammary pathway, which has a significant promoting effect on infant health. These strains are natural and evolutionarily adapted, so they are generally considered safe. In contrast, fecal-derived strains may contain a variety of bacteria (including beneficial bacteria and potential pathogens), and because their composition is more complex, they require more rigorous screening and verification.

In 2023, the technical development team published a breakthrough research result in the journal Microbiology Spectrum. The study conducted a comprehensive analysis of 31 AKK bacteria isolates from healthy individuals (30 from feces and 1 from breast milk). The study found that the AM06? AKK strain from healthy breast milk has significant advantages over the AKK strain from healthy human feces in terms of low toxicity, high genetic stability, high pH and bile salt tolerance, making it an ideal candidate for probiotic applications in food.

Inactivated AKK AM06? strain raw materials, better effect and wider commercial application

AKK AM06? strain uses its own PROFORCARE? Heat-InActived inactivation technology, which can completely inactivate AKK bacteria under low temperature conditions while keeping the bacteria intact and unbroken, retaining high genetic stability, and more adaptable to the complex environment of the gastrointestinal tract, while effectively retaining the active ingredients of the bacteria. Unlike live bacteria, inactivated probiotics are not affected by gastric acid and can be used with antibiotics, while live bacteria should not be taken with antibiotics. These characteristics make the inactivated AKK bacteria have a wider commercial application prospect, and also provide consumers with more product choices, which has significant advantages in the application field of probiotics.

Along the way, TECH-INNO Health has always been driven by innovation and devoted to the deep cultivation of the big health industry. We are not only actively engaged in research and development, but also look to the global market and seek in-depth cooperation with various partners, aiming to jointly expand the application boundaries of AKK AM06? in the health field, provide consumers with more comprehensive and scientific health solutions, and help realize the beautiful vision of universal health. In the future, TECH-INNO Health will continue to give full play to its own technological advantages and work with partners to create the future of the health industry, so that more people can enjoy the health benefits brought by probiotics. About Zhiyi Bio/Puwei Junjian Zhiyi Bio is one of the earliest units in China to carry out AKK research. It has published many scientific papers on the AKK AM06? strain and has applied for 22 domestic and foreign patents. Several National Natural Science Foundation projects have carried out basic research on AKK AM06?. Probiotics is a wholly-owned subsidiary of Zhiyi Biotechnology, focusing on the research and development of functional probiotics. It has China's leading innovative probiotics research and development and production system, and has built two production bases with 5000L fermentation tanks. Its production process capabilities are world-class, and its products meet pharmaceutical-grade quality control, with guaranteed quality, stability and production capacity.