XtalPi Holdings Limited Announces Major Business Breakthroughs: Peptide Ingredient Gains US Certification and Novel Cancer Drug Enters Clinical Stage
XtalPi Holdings Limited (Stock Code: 2228) has released a voluntary business update, revealing two significant achievements that could have material impact on its future growth and share value.
Key Highlights
- Breakthrough 1: Tensotide Peptide Ingredient Receives US Self GRAS Certification
- Breakthrough 2: Pan-TEAD Inhibitor SIGX2649 Secures Early FDA IND Approval for Solid Tumor Therapy
Details Investors Must Know
1. Tensotide: AI-Driven Peptide Ingredient with US Market Entry
- Tensotide is an innovative peptide ingredient developed in-house by XtalPi using its proprietary AI peptide discovery and optimization platform, PepiX™.
- It has successfully obtained Self GRAS (Generally Recognized as Safe) certification in the US, marking XtalPi’s first international safety certification in the oral food sector after previous registrations of Remeanagen™ and AquaKine™ for hair growth efficacy ingredients.
- This achievement demonstrates the industrialization capability of XtalPi’s AI peptide platform, extending from topical to oral administration products.
- Tensotide has secured a Chinese invention patent and completed PCT international patent application, providing intellectual property protection and potential exclusivity.
- The peptide acts on the energy metabolism pathway, inhibiting carbohydrate degradation and absorption. It is highly stable in strong acid, alkali, and enzymatic conditions, outperforming reference substances.
- Key advantages: High activity, high stability, high safety, and low cost/easy mass production.
- The US certification qualifies Tensotide for entry into the US food and dietary supplement market, opening a new revenue stream.
- XtalPi plans to expand into anti-aging cosmetic peptides, lipid-lowering peptides, and uric acid-lowering peptides, building a dual-track “Beauty and Health” matrix.
2. SIGX2649: Potential First-in-Class/Best-in-Class Cancer Therapy Advances to Clinical Trials
- SIGX2649, a pan-TEAD (TEAD 1-4) inhibitor targeting solid tumors, was developed by XtalPi’s incubated company, Signet Biotech.
- The drug received Investigational New Drug (IND) approval from the US FDA ahead of schedule, marking a significant milestone for XtalPi’s pipeline.
- This is the second innovative drug from Signet Biotech to enter clinical practice, following SIGX1094 for diffuse gastric cancer that is already in phase I trials.
- XtalPi maintains commercial interest in this pipeline, which could become a valuable asset.
- SIGX2649 targets the Hippo-YAP/TAZ pathway by binding TEAD, which is a co-factor of the core transcription factor YAP, an “undruggable” cancer target. It inhibits tumor proliferation, metastasis, and drug resistance.
- Preclinical data: Superior anti-proliferative activity in various in vitro models (e.g. liver cancer organoids, mesothelioma), significant in vivo antitumor efficacy, favorable pharmacokinetics, and lower renal toxicity compared to similar investigational drugs.
- Core preclinical data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, raising the profile of the drug and company.
Strategic Implications and Potential Share Price Impact
- The US certification for Tensotide and IND approval for SIGX2649 are both major milestones. The entry into the US food and supplement market and progression of a potential first-in-class oncology therapy could significantly enhance XtalPi’s growth prospects, revenue potential, and market valuation.
- Expansion into new therapeutic and consumer product categories further diversifies XtalPi’s portfolio and improves risk profile.
- Successful commercialization or positive clinical outcomes could drive substantial share price appreciation and attract new investor interest.
Corporate Information
XtalPi Holdings Limited was founded in 2015 by MIT physicists. Its R&D platform integrates quantum physics, AI, robotics, and cloud computing to deliver digital and intelligent solutions across pharmaceuticals, materials science, agriculture, energy, chemicals, and cosmetics.
Board Composition
Executive Directors: Dr. Wen Shuhao, Dr. Ma Jian, Dr. Lai Lipeng, Dr. Jiang Yide Alan
Independent Non-Executive Directors: Mr. Law Cheuk Kin Stephen, Ms. Chan Wing Ki, Mr. Chow Ming Sang
Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own due diligence and consult with professional advisors before making any investment decisions. The information provided is sourced from company announcements and may be subject to change or interpretation.
香港交易所上市公司XtalPi Holdings Limited公佈重大業務突破：肽類成分獲美國認證及新腫瘤藥進入臨床階段
XtalPi Holdings Limited（股份代號：2228）自願公佈業務最新進展，透露兩項重大突破，可能對公司未來增長及股價產生重大影響。
重點摘要
- 突破一：肽類成分Tensotide獲美國Self GRAS認證
- 突破二：泛TEAD抑制劑SIGX2649提前獲FDA IND批準，用於固體腫瘤治療
股東必須關注的重要細節
1. Tensotide：AI驅動肽類成分進入美國市場
- Tensotide由XtalPi自主開發，利用AI肽類發現與優化平台PepiX™。
- 成功獲得美國Self GRAS（普遍認為安全）認證，是公司在口服食品領域的首個國際安全認證，繼Remeanagen™及AquaKine™於美國登記後取得新突破。
- 標誌著XtalPi AI肽類平台從外用到口服產品的全產業鏈能力。
- Tensotide已獲得中國發明專利並完成PCT國際專利申請，保障知識產權。
- 該肽類作用於能量代謝途徑，抑制碳水化合物分解及吸收，在強酸、強鹼及酶條件下穩定性高，優於同類參考物。
- 四大差異化優勢：高活性、高穩定性、高安全性、低成本易於量產。
- 美國認證賦予Tensotide合規進入美國食品及膳食補充劑市場核心資格，開啟新收入來源。
- 公司計劃進一步拓展抗衰老、降脂、降尿酸肽類產品，構建“美麗與健康”雙軌矩陣。
2. SIGX2649：潛力“同類首創/最佳”腫瘤療法進入臨床
- SIGX2649為泛TEAD（TEAD 1-4）抑制劑，由XtalPi孵化公司Signet Biotech自主開發。
- 該藥提前獲美國FDA IND批準，進入臨床階段，是公司重要里程碑。
- 這是Signet Biotech第二條創新藥進入臨床，首款SIGX1094已進入胃癌I期臨床。
- XtalPi對該管線擁有商業權益，潛在成為價值資產。
- SIGX2649針對Hippo-YAP/TAZ通路，結合TEAD蛋白（YAP核心轉錄因子協同因子，屬“不可藥物化”靶點），抑制腫瘤增殖、轉移及耐藥。
- 前臨床數據：在多種腫瘤體外模型（如肝癌類器官、間皮瘤）中抗增殖活性強，體內抗腫瘤效果顯著，藥代動力學優良，腎毒性低於同類藥物。
- 核心數據將於美國癌症研究協會（AACR）2026年年會發表，提升公司及藥物知名度。
戰略意義及股價潛在影響
- 兩項突破均屬重大里程碑。進入美國食品補充劑市場及創新腫瘤藥臨床進展，將顯著提升公司增長前景、收入潛力及估值。
- 新產品線及治療領域拓展，有助分散風險與提升競爭力。
- 若商業化成功或臨床結果正面，將帶動股價上升及吸引更多投資者。
公司簡介
XtalPi Holdings Limited於2015年由麻省理工學院物理學家創立，平台融合量子物理、AI、機器人及雲計算，為醫藥、材料科學、農業技術、能源、新化學品及化妝品行業提供智能研發解決方案。
董事會組成
執行董事：溫舒豪博士、馬健博士、賴立鵬博士、蔣毅德博士
獨立非執行董事：羅卓健先生、陳穎琪女士、周明生先生
免責聲明：本文僅供參考，並非投資建議。投資者應自行審慎評估並諮詢專業顧問。本資訊源自公司公告，可能會隨時變動或被重新解讀。
