Suzhou, China, June 02, 2026 (GLOBE NEWSWIRE) -- Thankcome Biological Science and Technology Co., Ltd. ("Thankcome"), a subsidiary of Perfect Group Corp., Ltd. (SSE: 603059), today announced that its proprietary next-generation probiotic strain, Akkermansia muciniphila AKK PROBIO® (CGMCC No.20955), has successfully completed the U.S. Food and Drug Administration (FDA) New Dietary Ingredient (NDI) notification process. To the company's knowledge, AKK PROBIO® is the first Akkermansia muciniphila strain of human intestinal origin to complete the NDI pathway, further strengthening its regulatory position alongside the dual self-affirmed GRAS certification achieved in 2024.
Establishing a Comprehensive U.S. Regulatory Framework
While another Akkermansia muciniphila strain has entered the NDI notification process, AKK PROBIO® is, to the company's knowledge, the first to complete this pathway with a strain of human intestinal origin — the natural habitat of Akkermansia muciniphila. Strains isolated from the human gut are naturally adapted to the intestinal environment, which may support biological relevance for colonization and function.
The combination of self-affirmed GRAS and NDI creates a comprehensive regulatory framework for AKK PROBIO® across both food and dietary supplement applications in the U.S. market:
- Self-affirmed GRAS (2024): Supports use in conventional foods and beverages under 21 CFR §170.30 — dual certified for both live (probiotic) and pasteurized (postbiotic) forms.
- FDA NDI notification (2026): Supports use as a dietary ingredient in dietary supplements.
This dual regulatory foundation provides enhanced compliance confidence for global brand owners, formulators, and commercial partners seeking scientifically substantiated Akkermansia ingredients for the North American market.
Leadership Commentary
"Achieving NDI notification, following our dual self-affirmed GRAS certification, is a significant step forward for AKK PROBIO® and for the Akkermansia category as a whole. Our strain was isolated from the gut microbiota of a Chinese swimming champion, developed through rigorous screening, and is now supported by 13 peer-reviewed publications and 7 clinical studies. With both GRAS and NDI pathways completed, we are well-positioned to support our global partners with a science-backed, compliant Akkermansia ingredient for the U.S. market." — Chris Yu, CEO, Thankcome Biotech
Scientific and Clinical Foundation of AKK PROBIO®
AKK PROBIO® (CGMCC No.20955) was originally isolated from the gut microbiota of a Chinese swimming champion and is the result of years of proprietary microbiome research conducted by Thankcome. The strain is supported by:
- 18 granted domestic and international invention patents
- 13 peer-reviewed scientific publications — among the most published of any individual Akkermansia strains
- 7 clinical studies, including one of the world's largest randomized controlled trials on the brain-gut axis with live Akkermansia (8 weeks, P < 0.001)
- Award-winning innovation: 2025 iCAN International Innovation Competition Gold Medal and Special Award (Canada); 2025 Ingredient Idol Award for Weight Management; featured at Natural Products Expo West 2025
Key Differentiators
Gut-Derived Origin. Isolated from healthy human gut microbiota — the natural habitat of Akkermansia muciniphila. A gut-derived strain is biologically adapted to the human intestinal environment, which may support colonization and function in the human gastrointestinal tract.
Dual-Form Availability. Available in both live (probiotic) and pasteurized (postbiotic) forms, both with GRAS certification. The live form uses proprietary shell coating technology for oxygen resistance. The pasteurized form preserves critical membrane proteins (including Amuc_1100) and secreted proteins (including P9) through controlled heat treatment.
Proven Clinical Results. The landmark 8-week RCT demonstrated statistically significant improvements in body weight, BMI, waist-to-hip ratio, liver function, lipid metabolism, emotional well-being, and gut microbiota composition versus placebo (P < 0.001).
Broad Application Range. Research supports applications across weight management, gut barrier integrity, metabolic health, immune modulation, GLP-1 secretion, and the gut-brain axis — relevant for dietary supplements, functional foods and beverages, sports nutrition, and pet health products.
Advancing the Global Akkermansia Category
The achievement of both GRAS and NDI milestones reflects growing international recognition of Akkermansia muciniphila as a commercially viable next-generation probiotic, and of Thankcome's leadership in strain science, manufacturing quality, and regulatory strategy.
As a subsidiary of Perfect Group Corp., Ltd. (SSE: 603059), Thankcome will continue to expand clinical research, pursue international regulatory approvals, and build strategic partnerships to bring science-backed, compliant Akkermansia solutions to global markets.
In the United States, AKK PROBIO® is distributed by Maypro (New York), an established specialty ingredient distribution partner.
About Thankcome
Thankcome Biological Science and Technology Co., Ltd., a subsidiary of Perfect Group Corp., Ltd. (SSE: 603059), is dedicated to the research, development, and commercialization of next-generation probiotics and functional microbial solutions. The company focuses on scientific innovation, global regulatory compliance, and industrial-scale manufacturing to support the future of precision microbiome health. For more information, visit http://www.thankcome.com
About AKK PROBIO®
Developed by Thankcome, AKK PROBIO® is a next-generation Akkermansia muciniphila probiotic with 18 granted patents and 13 peer-reviewed publications. It is the first Akkermansia strain of human intestinal origin to complete the FDA NDI notification process and the first globally to achieve dual self-affirmed GRAS certification for both live and inactivated forms. Backed by 7 clinical studies, AKK PROBIO® is designed to support metabolic, gut, and immune health. For more details, visit http://www.akkprobio.com
Press Inquiries
Yang Liu
akk [at] thankcome.com
https://www.thankcome.com
