XtalPi's AI-Designed Oral Peptide Tensotide™ Secures U.S. Self-Affirmed GRAS Certification, Targeting the Multi-Billion-Dollar Metabolic Health Consumer Market

XtalPi, a globally leading AI+robotics platform enterprise for drug and materials R&D (2228.HK) announced today that, leveraging its AI-powered peptide development platform PepiX™,The company has successfully independently developed an innovative oral food ingredient focused on blood glucose health management—Tensotide™ peptide, which has obtained U.S. Self-affirmed GRAS (Generally Recognized As Safe) status.This signifies that Tensotide™ is classified as a “Generally Recognized as Safe” (GRAS) food-grade ingredient, legally permissible for use in food and dietary supplement products in the United States. This follows the company’s previous successful launches of its hair-strengthening active ingredients, the “twin star” peptides AquaKine™ and the small-molecule Remeanagen™.XtalPi Achieves Another Key Milestone in the Consumer Health Sector, further validating the continuous translational capability of its AI R&D platform in the development of consumer goods and food ingredient components.

Leveraging AI to Enter the Trillion-Yuan Metabolic Health Management Market,

Cracking the “Impossible Triangle” of Oral Products

The global population with obesity and hyperglycemia continues to surge, making metabolic health one of the most rigid consumer demands. According to a Frost & Sullivan report, the global market for weight-loss health supplements exceeded $20 billion in 2025, with China's market achieving a compound annual growth rate (CAGR) of over 14%.

Currently, blood sugar control and weight loss products on the market generally face a dilemma: “effective ones are unsafe, safe ones have weak efficacy, and highly effective ones are expensive.” Although GLP-1 prescription drugs demonstrate clear therapeutic efficacy, they are costly, require injection, and their oral formulations come with numerous usage restrictions. Furthermore, they carry overall warnings regarding gastrointestinal and thyroid-related side effects, limiting their use to medical supervision only, which makes them unsuitable for daily health management among the general population. In the realm of oral products, various technological approaches also exhibit significant shortcomings: traditional health supplements containing natural plant ingredients, such as charantin and white kidney bean extract, have unclear mechanisms of action, insufficient clinical evidence, and non-standardized effects; common functional peptides and oral macromolecular proteins, mostly being natural fragments, suffer from poor stability and are easily degraded by gastric acid, making it difficult for them to function stably in the digestive tract, thus limiting their industrialization value; small-molecule chemical compounds are constrained by strict regulations, hindering their entry into everyday consumer scenarios. There is an urgent market need for consumer-grade products that are safer, more effective, and readily accessible for daily use.

Tensotide™ is specifically designed to address this market gap, offering differentiated advantages such as high efficacy, superior stability, an excellent safety profile, and cost-effective, scalable manufacturing.WorkAs an ingredient suitable for inclusion in foods and dietary supplements, it offers a wider range of daily product options for individuals managing their blood sugar levels.。From the outset of project initiation, XtalPi selected physiological mechanisms with extensive validation for safety and efficacy, focusing on regulating energy metabolic pathways and inhibiting the degradation and absorption of carbohydrates as the core mechanism.To provide consumers with blood glucose management needs an adjunctive solution that can be integrated into their daily diet。This component demonstrates favorable efficacy in animal models, reducing postprandial blood glucose peaks by up to 30%.Meanwhile, Tensotide™ demonstrates good stability under conditions of 40°C, strong acids, strong bases, and various digestive enzymes.Solved the long-standing “oral administration challenge” hindering the industrialization of functional peptides, thereby ensuring broad applicability in the application scenarios of health supplements and food additives.

* The above experimental data are derived from animal models and do not represent the actual performance of the product.Efficacy does not represent human usage effects; product efficacy varies from person to person.

Currently, this ingredient has been granted a Chinese invention patent, completed the PCT international patent application, and undergone kilogram-scale industrial production validation.This demonstrates that XtalPi has established a complete end-to-end workflow for oral functional peptides, spanning from AI-driven design and regulatory compliance filing to industrial-scale mass production, with commercialization conditions nearing maturity.

* The above experimental data are derived from mouse models and do not represent the actual performance of the product.Efficacy does not represent human usage results; product efficacy varies from person to person.

Tensotide™, as a colorless, odorless oral functional peptide with an outstanding safety profile, can be used for the development of dietary supplements and flexibly added to foods as a food ingredient.In daily consumer goods such as staple foods, snacks, and beverages that meet consumers’ demand for low-glycemic-index (GI) diets, the pricing system of food ingredients holds a natural advantage in affordability, offering strong potential for rapid market penetration and broader applicability. Leveraging its regulatory compliance, safety profile, and application flexibility, Tensotide™ is poised to become the next-generation flagship functional ingredient in the health and wellness consumer products sector.

From Cosmetics to Food:

Continuous Breakthroughs in the Consumer Goods Sector

The approval of Tensotide™ is not the first time XtalPi has extended its AI platform capabilities to the consumer health sector. Previously, the company successfully registered AI-designed and screened hair-strengthening active ingredients as cosmetic ingredients: the peptide AquaKine™ and the small molecule Remeanagen™. Groland’s Scalp Revitalizing Essence, developed based on these two ingredients, ranked first on Tmall’s list of new anti-hair-loss products and was recently included in InStyle magazine’s 8th Annual Beauty Must-Buy List.

Tensotide™’s recent international compliance certification for food ingredients further extends XtalPi’s footprint in functional consumer ingredients from beauty and personal care into dietary health.This marks the achievement of technology reuse and commercial closed-loop by XtalPi’s AI platform across the three major sectors of pharmaceuticals, cosmetics, and dietary supplements.

This cross-sector expansion demonstrates XtalPi’s systemic advantage in efficiently transferring its core AI and robotics capabilities across different market demands and regulatory pathways. By prioritizing product safety and user experience, the company applies its cutting-edge molecular design capabilities to the discovery and development of innovative functional ingredients for cosmetics and food products, thereby enabling entry into the consumer goods sector—characterized by substantial market potential and clear cash flow streams—through shorter regulatory approval pathways.This has enabled XtalPi to build a high-potential second growth curve beyond its core drug development business.

Dr. Wen Shuhao, Chairman of the Board of Directors of XtalPi, stated:“Tensotide™ has received authoritative U.S. certification, marking a significant validation of the PepiX™ platform in the consumer health sector. It demonstrates our ability to leverage pharmaceutical-grade molecular development capabilities to efficiently deliver safe and accessible daily health solutions. This is not merely a breakthrough for a single molecule, but also represents a vast untapped market—enabling AI-driven precision molecular design to develop products that truly meet mass-market needs, thereby allowing the inclusive benefits of AI technology to genuinely improve people’s lives.”

With the regulatory approval and commercial launch of three molecules—Tensotide™, AquaKine™, and Remeanagen™—XtalPi has established a dual-track portfolio in consumer health, spanning metabolic wellness and aesthetic anti-aging. Looking ahead, XtalPi will continue to expand its development of consumer-grade ingredients in high-demand areas such as anti-aging, lipid management, and uric acid control. Addressing core market needs in health and beauty, the company will leverage its high-standard R&D platform to consistently design and deliver functional molecules with high safety profiles suited for daily use. This strategy aims to gradually extend health management and rejuvenation from clinical settings into everyday consumer scenarios, providing the public with effective, high-quality products.

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, spanning from source innovation and precision design to industrial implementation. Traditional peptide R&D heavily relies on a “trial-and-error” approach, commonly facing three major bottlenecks: blind design, poor stability, and difficulties in industrialization. Molecular hit rates are less than 5%, development cycles span 1 to 3 years, and natural peptides are prone to enzymatic degradation, entail high synthesis costs, and are difficult to produce stably at scale.

The PepiX™ platform integrates three core capabilities—generative AI-driven molecular design, automated synthesis, and high-throughput wet-lab screening—to establish an efficient closed-loop system of “in silico design and wet-lab validation.” On the design front, AI algorithms simultaneously optimize stability, target affinity, and oral bioavailability across vast sequence spaces. On the validation front, scalable, parallel automated robotic workstations enable the rapid synthesis and activity testing of thousands of candidate molecules, compressing development timelines from years to months. It is this engineered R&D framework that allows Tensotide™ to be developed under pharmaceutical-grade platform standards, thereby ensuring food-grade safety. While maintaining high potency, this peptide molecule exhibits robust structural stability under varying pH conditions and in the presence of diverse enzymes., it can be widely applied in various food matrices, becoming a highly competitive new generation of oral functional ingredients. In the peptide synthesis stage, the production process has achieved stable kilogram-scale mass production, with purity exceeding 95%, controllable costs, and conditions for large-scale commercialization.

The PepiX™ platform comprehensively covers the peptide drug discovery process, from Hit (hit compound) 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 technological implementation across multiple tracks and is strategically focusing on the development of various high-potential peptide molecules, including those for brain/eye delivery, oral peptides, and cyclic peptides.

Compliance Statement:Tensotide™ is a food-grade ingredient that complies with relevant regulations. The information contained herein does not constitute any claim regarding the product’s therapeutic, disease-preventive, or health-promoting effects.