XTALPI (02228) announced that the company has recently achieved two breakthrough advancements in its self-developed innovative peptide food ingredient and the drug pipeline of its incubated enterprise. First, Tensotide, an innovative peptide food ingredient independently developed by XTALPI using its AI peptide discovery and optimization platform PepiX™, has successfully obtained Self-GRAS certification in the United States. Following the registration and filing of hair growth efficacy ingredients (Remeanagen™ and AquaKine™) in the U.S., this marks XTALPI's first international safety certification in the oral food sector, signifying that the company's AI peptide platform has established full-chain industrial capabilities from "topical" to "edible" applications. Tensotide is an innovative active peptide independently designed by XTALPI, which has already secured a Chinese invention patent and completed a PCT international patent application. Targeting the energy metabolism pathway as its core mechanism, Tensotide inhibits the degradation and absorption of carbohydrates. This peptide maintains significantly stronger stability than similar positive controls under conditions of strong acids, strong bases, and various enzymes, offering the four distinct advantages of high activity, high stability, high safety, and low cost with easy mass production. With this certification, Tensotide now possesses the core qualifications for compliant entry into the U.S. food market and dietary supplements. In the future, XTALPI will continue to expand into areas such as anti-aging cosmetic peptides, lipid-lowering peptides, and uric acid-reducing peptides, building a dual-track matrix for "beauty and health." Second, SIGX2649, a potential first-in-class/best-in-class solid tumor-targeted drug and pan-TEAD (TEAD 1-4) inhibitor independently developed by XTALPI's incubated company, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) ahead of schedule. This marks the second innovative drug pipeline from the incubated company to enter clinical trials, following the world's first diffuse gastric cancer-targeted drug SIGX1094, which has already entered Phase I clinical studies. XTALPI holds the commercialization rights for this pipeline. SIGX2649 is a pan-TEAD (TEAD 1-4) inhibitor that blocks the Hippo-YAP/TAZ signaling pathway by targeting TEAD, the binding protein of the core transcription factor YAP (a previously undruggable target) in the Hippo pathway, thereby inhibiting the proliferation, metastasis, and drug resistance of solid tumors. Preclinical studies have shown that SIGX2649 exhibits excellent anti-proliferative activity in various tumor models in vitro (including liver cancer organoids and mesothelioma, among others), demonstrates significant tumor-inhibiting effects in vivo, has favorable pharmacokinetics, and shows lower renal-targeted toxicity compared to similar drugs under research. Key preclinical research data for SIGX2649 has been selected for presentation at the 2026 American Association for Cancer Research (AACR) Annual Meeting.
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