Thankcome Announces FDA NDI Notification Completion for AKK PROBIO® Akkermansia muciniphila

Thankcome Biological Science and Technology (Su Zhou) Co., Ltd. (“Thankcome”) is proud to announce that its proprietary next-generation probiotic strain, Akkermansia muciniphila AKK PROBIO®, has successfully completed the U.S. Food and Drug Administration (FDA) New Dietary Ingredient (NDI) notification process for use in dietary supplements.

This achievement follows the strain’s successful GRAS (Generally Recognized as Safe) conclusion in October 2024, creating a complete regulatory foundation for AKK PROBIO® in the U.S. market — covering both food and dietary supplement applications.

As one of only a small number of Akkermansia strains globally to complete the FDA NDI pathway, AKK PROBIO® reflects the growing maturity of next-generation probiotics in the international health and nutrition industry.

A Dual Regulatory Framework for the U.S. Market

The combination of GRAS and NDI status provides a comprehensive compliance framework, enabling AKK PROBIO® to be used across two key categories in the United States:

· GRAS Conclusion (2024): Supports the use of AKK PROBIO® in conventional food applications.

· FDA NDI Notification (2026): Supports its use as a dietary ingredient in dietary supplements.

This dual regulatory foundation gives global brand owners, formulators, and commercial partners enhanced confidence in offering scientifically substantiated Akkermansia ingredients to the North American market.

FDA NDI notifications require rigorous scientific validation, including full strain characterization, manufacturing process validation, toxicological evaluation, stability testing, and comprehensive safety documentation. Successfully completing this process demonstrates the robust scientific and quality systems that underpin AKK PROBIO®.

About AKK PROBIO®: Science-Backed Innovation

AKK PROBIO® (CGMCC No. 20955) was originally isolated from the gut microbiota of a healthy elite athlete in China, following years of proprietary microbiome research conducted by Thankcome.

The strain is supported by an extensive scientific portfolio, including:

18 granted domestic and international patents

13 scientific publications

7 clinical studies, including one of the world’s largest human clinical cohorts involving Akkermansia

Compared to conventional Akkermansia products, AKK PROBIO® offers distinct advantages in safety, stability, and industrial applicability.

High Safety Profile

AKK PROBIO® has undergone thorough safety evaluations, including acute toxicity, subchronic toxicity, and antimicrobial resistance assessments. No potential virulence concerns were identified during testing.

Advanced Stability & Manufacturing Capability

Using proprietary manufacturing technologies, AKK PROBIO® preserves critical functional components such as outer membrane proteins and secreted bioactive compounds. This helps maintain stability during storage, transportation, and commercial formulation.

Broad Functional Potential

Clinical studies suggest AKK PROBIO® may help support:

Gut barrier integrity

Metabolic health

Immune balance

Microbiome modulation

This broad functional profile makes it suitable for a wide range of modern health applications.

Supporting the Global Development of Next-Generation Probiotics

The successful completion of both GRAS and NDI pathways marks a key milestone in the international recognition of Chinese microbiome innovation, scientific research capabilities, and manufacturing quality systems.

As a subsidiary of Perfect Dental Care Group (SH603059), Thankcome remains committed to advancing microbiome science through:

Continuous research investment

Global regulatory development

International collaboration

The company will continue expanding clinical research and global commercialization efforts for AKK PROBIO®, with the goal of providing science-backed, compliant, and high-quality next-generation probiotic solutions to partners and consumers worldwide.

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About Thankcome Biological Science and Technology (Su Zhou) Co., Ltd.

Thankcome Biological Science and Technology (Su Zhou) Co., Ltd. is a microbiome-focused biotechnology company dedicated to the research, development, and commercialization of next-generation probiotics and functional microbial solutions. The company prioritizes scientific innovation, global regulatory compliance, and industrial-scale manufacturing to support the future of precision microbiome health.