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ShenzhenJune 2, 2026 /PRNewswire/ — XtalPi (2228.HK), a globally leading AI and robotics-driven drug and materials R&D platform company, today announced that, leveraging its AI peptide development platform PepiX™, it has successfully developed an innovative oral food ingredient for blood glucose health management—the peptide Tensotide™—which has received U.S. Self-affirmed GRAS (Generally Recognized as Safe) designation. This marks Tensotide™ as a “generally recognized as safe” food-grade ingredient, legally applicable in food and dietary supplement products in the United States. This represents another key milestone for XtalPi in the consumer health sector, following the successful launch of the hair-strengthening “twin” ingredients, the peptide AquaKine™ and the small molecule Remeanagen™, once again validating the sustained conversion capability of its AI R&D platform in developing consumer goods and food ingredient components.
XtalPi’s Food-Grade Oral Peptide Tensotide™ Receives U.S. Self-GRAS Certification
Entering the Hundred-Billion Metabolic Health Management Market with AI,
Breaking the “Impossible Triangle” of Oral Products
The global population of obese and hyperglycemic individuals continues to surge, making metabolic health one of the most essential consumer demands. According to a Frost & Sullivan report, the global weight management health food market exceeded $20 billion in 2025, with the Chinese market growing at a compound annual growth rate of over 14%.
Currently, sugar-control and weight-loss products on the market generally face a dilemma: “effective ones are unsafe, safe ones are ineffective, and effective ones are expensive.” While GLP-1 class prescription drugs offer clear efficacy, they are costly, require injection, and oral formulations have numerous usage restrictions, along with warnings about gastrointestinal and thyroid-related side effects, limiting their use to medical supervision and making them unsuitable for everyday health management. In the oral product domain, various technological approaches also have significant shortcomings: traditional health supplements like bitter melon extract and white kidney bean extract have unclear mechanisms of action and insufficient clinical evidence, making standardization of effects difficult; common functional peptides and oral macromolecular proteins are often natural fragments with poor stability, easily degraded by gastric acid, and struggle to function stably in the digestive tract, limiting their industrial value; small molecule chemical ingredients are subject to strict regulations, hindering their entry into daily consumer scenarios. The market urgently needs safer, more effective, and accessible consumer-grade products.
The design of the Tensotide™ molecule directly targets this market gap, offering differentiated advantages including good efficacy, high stability, high safety, controllable costs, and ease of mass production. As an ingredient that can be added to food and dietary supplements, it provides a richer array of daily product options for those managing blood sugar. From the project’s inception, XtalPi chose a physiological mechanism with extensive safety and efficacy validation, focusing on regulating energy metabolism pathways and inhibiting carbohydrate degradation and absorption as its core mechanism, offering a supplementary solution that can be integrated into daily diets for consumers with blood sugar management needs. This ingredient has demonstrated good efficacy in animal models, reducing postprandial blood glucose peaks by up to 30%. Additionally, Tensotide™ exhibits excellent stability in environments at 40°C, strong acids, strong bases, and tolerance to various digestive enzymes, solving the long-standing “oral administration challenge” that has plagued the industrialization of functional peptides, making it widely applicable in health supplements and food additive scenarios.
XtalPi’s Oral Ingredient Tensotide™ Shows Good Efficacy in Animal Models, Reducing Postprandial Blood Glucose Peaks by Up to 30%
* The above experimental data originates from animal models. These results do not represent actual product efficacy or human use effects; product efficacy varies from person to person.
Currently, this ingredient has been granted a Chinese invention patent and has completed PCT international patent applications and kilogram-scale industrial production validation, indicating that XtalPi has established a complete chain for oral functional peptides—from AI design and regulatory compliance to industrial-scale production—with commercialization conditions approaching maturity.
XtalPi’s Oral Ingredient Tensotide™ Shows Superior Tolerance to Strong Acids, Strong Bases, and Various Digestive Enzymes, Solving the ‘Oral Administration Challenge’ in Peptide Development
* The above experimental data originates from mouse model animals. These results do not represent actual product efficacy or human use effects; product efficacy varies from person to person.
As a colorless, odorless oral functional peptide with outstanding safety, Tensotide™ can be used in dietary supplement development or flexibly added as a food ingredient to staples, snacks, beverages, and other daily consumer products meeting low glycemic index (GI) dietary needs. The pricing system for food ingredients inherently offers advantages in affordability, with potential for rapid market penetration and applicability to a broader population. With its compliance qualifications, safety, and application flexibility, Tensotide™ is poised to become a next-generation iconic functional ingredient in the health consumer goods market.
From Cosmetics to Food:
Continuous Breakthroughs in the Consumer Sector
The approval of Tensotide™ is not XtalPi’s first expansion of its AI platform capabilities into the consumer health sector. Previously, the company successfully registered AI-designed and screened hair-strengthening ingredients as cosmetic components—the peptide AquaKine™ and the small molecule Remeanagen™. Products developed from these two ingredients, such as Groland Gaolan Scalp Revitalizing Serum, have ranked first on Tmall’s anti-hair loss new product list and were recently featured on Instyle magazine’s 8th Annual Beauty Must-Have List.
This Self-GRAS designation for Tensotide™ extends XtalPi’s footprint in consumer product functional ingredients from beauty and personal care to dietary health, marking a technological reuse and commercial closed loop for XtalPi’s AI platform across the three major fields of pharmaceuticals, cosmetics, and dietary supplements.
This cross-sector expansion demonstrates XtalPi’s systemic advantage in efficiently migrating its core AI+robotics capabilities to meet different market demands and compliance pathways. By prioritizing product safety and user experience, the company applies its cutting-edge molecular design capabilities to the discovery and development of innovative cosmetic and food ingredients, entering the vast market space and cash-flow-clear consumer goods sector through shorter compliance pathways. This builds a high-potential second growth curve for XtalPi alongside its primary drug R&D focus.
Dr. Shuhao Wen, Chairman of XtalPi, stated: “Tensotide™ receiving this authoritative U.S. certification is a significant validation of the PepiX™ platform in the consumer health field. It proves we can leverage pharmaceutical-grade molecular development capabilities to efficiently deliver safe and accessible daily health solutions. This is not just a breakthrough for a single molecule but represents a blue ocean market—using AI-driven precision molecular design to develop products that truly meet public needs, allowing the democratization of AI technology to genuinely improve people’s lives.”
With the regulatory certifications and commercialization of the three molecules—Tensotide™, AquaKine™, and Remeanagen™—XtalPi has established a dual-track consumer health matrix covering metabolic health and beauty/anti-aging. Looking ahead, XtalPi will continue to expand into hot consumer ingredient areas such as anti-aging, blood lipid management, and uric acid management. Targeting core public demands in health and beauty, the company will leverage its high-standard R&D platform to continuously design and produce functional molecules with high safety suitable for daily use, gradually extending health management and rejuvenation from medical settings to daily consumer scenarios, delivering effective, high-quality products to the public.
PepiX™ AI Platform Empowerment:
Bringing Functional Peptide Discovery into the Engineering Era
The success of Tensotide™ is no accident; it once again validates the end-to-end capabilities of XtalPi’s PepiX™ AI peptide development platform, from source innovation and precision design to industrial implementation. Traditional peptide R&D relies heavily on “trial and error,” commonly facing three major bottlenecks: blind design, poor stability, and industrialization difficulties—with molecular hit rates below 5%, R&D cycles lasting 1 to 3 years, and natural peptides being prone to enzymatic degradation, high synthesis costs, and difficulty in stable mass production.
The PepiX™ platform integrates three core capabilities: generative AI molecular design, automated synthesis, and high-throughput wet lab screening, forming an efficient closed loop of “dry lab design + wet lab validation.” On the design side, AI algorithms can simultaneously optimize stability, target affinity, and oral bioavailability across a vast sequence space. On the validation side, large-scale parallel automated robotic workstations enable rapid synthesis and activity testing of thousands of candidate molecules, shortening R&D cycles from years to months. It is this engineering-based R&D system that allowed Tensotide™, developed to the high standards of a pharmaceutical-grade platform, to achieve food-grade safety assurance. While maintaining high activity, this peptide molecule retains good structural stability under various acidic, alkaline, and enzymatic conditions, making it widely applicable in various food matrices and a highly competitive next-generation oral functional ingredient. In the peptide synthesis phase, the production process has achieved kilogram-scale stable mass production with purity exceeding 95%, controllable costs, and readiness for large-scale commercialization.
The PepiX™ platform fully covers the peptide drug discovery process from Hit identification to PCC (Preclinical Candidate Compound) development, supporting various molecular types including linear peptides, cyclic peptides, and bicyclic peptides. Currently, the PepiX™ platform has achieved multi-track technology implementation and is strategically focusing on the development of high-potential peptide molecules for brain/eye delivery, oral peptides, cyclic peptides, and other types.
About XtalPi
XtalPi (“XtalPi Holdings Limited”, stock short name: XtalPi, stock code: 2228.HK) was founded in 2015 by three physicists from the Massachusetts Institute of Technology. It is an innovative R&D platform based on quantum physics, empowered by artificial intelligence, and driven by robotics. The company combines quantum physics-based first-principles calculations, artificial intelligence, high-performance cloud computing, and scalable, standardized robotic automation to provide drug and materials science R&D solutions and services to global and domestic companies in the pharmaceutical and materials science industries (including agricultural technology, energy and new chemicals, and cosmetics).