The FDA’s

Innovative Roadmap for Reducing Animal Testing

hiPSCの標準化から創薬ツールまで、
NEXELが技術革新をリードします。

Through its Roadmap for Reducing Animal Testing — New Approach Methodologies (NAMs) —

the FDA is driving a global shift toward more accurate and ethical alternatives

At the forefront of this transformation, NEXEL turns the vision of NAMs into reality —

pioneering an ethical, animal-free future for the world

In response, NEXEL

NEXELは創薬ツール（Drug Development Tool）プラットフォームを基盤に、グローバルな新薬開発の新たな標準を築きます。

PRODUCT

NEXELの製品について知ってください。

  • iPSC Derived Cells

    iPS細胞由来の心筋細胞、神経細胞、肝細胞を使って、
    薬物反応性、3Dプリンティング、電気生理学
    的実験を試してみてください！

    view more
  • Organoid

    iPS細胞由来の
    心臓オルガノイドについて知ってください！

    view more
  • Instruments

    3D組織（筋肉、心臓）収縮力分析
    バイオミメティック細胞ストレッチングデバイス
    ナノスケールパターンプレート

    view more

  • SERVICE

    NeXST

    NeXST

    NeXST心臓安全性サービスは、新薬開発企業が 薬物開発プログラムにおいて効率的な意思決定を 行うことを支援することを目的としています。

  • CDMO

    CDMO

    疾患モデルや特定の分化など、希望する細胞を カスタマイズして製造するサービスです。

  • iPSC REPROGRAMMING

    iPSC REPROGRAMMING

    線維芽細胞およびPBMC（末梢血単核細胞）を iPSCにリプログラムするサービスです。

NEWS

NEXEL receives U.S. FDA acceptance of letter of intent for iPSC-derived cardiomyocyte platform ‘Cardiosight-S’

  • - The ISTAND program places new ‘cardiac’ safety assessment technology on an official FDA track as a replacement for animal testing - Cardiosight-S stands as the ‘world’s first’ cardiac safety assessment platform based on HiPSC-derived cardiac cells NEXEL's DDT-IST review status as listed on the FDA ISTAND program official website (Source: NEXEL)   [by Kang, In Hyo] NEXEL, a Korean biotechnology venture, has successfully advanced through the U.S. Food and Drug Administration’s (FDA) Innovative Science and Technology Approaches for New Drugs (ISTAND) qualification program.   NEXEL announced on July 16 that the FDA has officially accepted the Letter of Intent (LOI) for ‘Cardiosight-S,’ its proprietary cardiac safety assessment platform based on human induced pluripotent stem cells (hiPSC)-derived cardiomyocytes.   The decision comes under the FDA’s Drug Development Tool (DDT) Qualification Program, which is administered pursuant to Section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The LOI, titled ‘Qualification of a standardized hiPSC-Derived Cardiomyocytes Platform for Regulatory Cardiac Safety Assessment,’ was submitted to the FDA in April 2026.   In particular, the explicit inclusion of NEXEL’s cardiomyocyte product, ‘Cardiosight-S,’ in this Letter of Intent (LOI) is regarded as a significant milestone, reflecting regulatory recognition of the platform’s technical validity and overall completeness. Additionally, the company is considered to have demonstrated both its technological capabilities and strategic differentiation by becoming the first in the world to enter the ISTAND program through a unique regulatory strategy tailored to hiPSC-derived cardiomyocytes, distinguishing itself from other developers in the field.   The ISTAND program is a system in which the FDA evaluates and qualifies ‘new tools’ that fall outside existing regulatory frameworks, including stem cells, organoids, organ-on-a-chip technologies, and artificial intelligence (AI), for use in drug development and regulatory review. Once a tool receives ‘official qualification’ through the program, it can be immediately adopted by pharmaceutical companies worldwide as official tools in the drug development and regulatory approval processes without the need for additional verification for its qualified context of use.   With the FDA's acceptance of the Letter of Intent (LOI), NEXEL has officially entered the ‘formal regulatory review process’ for its platform. The company’s next step is to prepare and submit a ‘Qualification Plan (QP)’ outlining detailed study designs and validation data. Along with the LOI acceptance, the FDA provided recommendations to be incorporated into the QP, which NEXEL will use to guide its data generation and submission strategy.   "The FDA’s acceptance of our LOI marks the 'world's first' 'hiPSC-derived cardiomyocyte-based platform' to enter the FDA's official qualification review process. It represents a major milestone demonstrating the maturity of our technology in the field of 'New Approach Methodologies (NAMs),' which have the potential to replace animal testing. We will continue to diligently advance the QP submission and subsequent consultation procedures," a NEXEL official said.   NEXEL is a biotechnology company specializing in hiPSC-based cell and organoid products, as well as novel drug evaluation platforms. Building on this latest achievement, the company plans to further expand collaboration with Korean and international partners and customers.   THEBIO Kang, In Hyo (zenith@thebionews.net)
  • 2026-07-27

Nexel Leads the FDA Roadmap: Secures Full-Cycle Technologies from Organoid Development to Disease Modeling

  • Following the recent release of the “New Approach Methodologies (NAMs)” roadmap by the U.S. Food and Drug Administration (FDA), the global bio R&D market is entering a period of significant transformation.   The FDA has highlighted the limitations and ethical issues of animal testing, announcing that within the next three to five years, non-animal testing methods using human-derived cell technologies—such as organoids and organ-on-a-chip—will serve as new standards for preclinical toxicity evaluations.   As a result, organoid platforms that simulate key human organs such as the heart, liver, and nervous system are expected to become core technologies in future drug development. Organoids are three-dimensional mini-organs or tissue analogs created from stem cells, possessing structural and functional characteristics similar to human organs.   Amid this shift, Nexel is taking the lead on the FDA roadmap by leveraging its technological capabilities in human-induced pluripotent stem cells (hiPSC) to advance organoid and drug candidate research. The company is also securing related intellectual property rights.   Nexel has obtained patents in Korea and Japan for its “method for producing cardiac organoids” and has filed applications in the United States, Europe, and China. In March, the company completed registration of a “drug evaluation method using cardiac organoids” and is now securing international rights through a Patent Cooperation Treaty (PCT) application, it announced on the 21st.   The company also reported progress in the area of disease modeling using hiPSC-derived organoids, capable of replicating pathological phenomena. Nexel has completed both domestic and PCT applications for a “method for inducing heart failure models caused by myocardial infarction and cardiac fibrosis.” Additionally, in collaboration with the Korea Institute of Toxicology (KIT), the company has finalized a patent registration for a Wilson’s disease model using liver organoids.   A Nexel official stated, “This marks the foundation for leading the NAMs-centered era, as we have secured patents not only for organoid production and functional evaluation, but also for disease simulation—covering the full cycle of organoid technologies.”   Nexel is also building a new growth engine through new drug development by securing domestic and international patent rights for hiPSC-derived drug candidates (NP-011 and NPT-0025).   The company’s NP-011 candidate, which has obtained patent registrations in the U.S. and Japan as of April this year, covers various indications including liver diseases, heart diseases, and pulmonary fibrosis. The patent is currently under examination in the EU and China. In January, the company secured a domestic patent for use in treating ulcerative colitis and has since filed a PCT application.   NPT-0025, another drug candidate, has received patent registrations in Korea and Japan for compositions targeting idiopathic pulmonary fibrosis, and is currently under review in the EU and China.   These patents represent the global protection of drug candidates discovered through hiPSC-based technologies, with the mechanisms of action and efficacy precisely demonstrated using hiPSC-based evaluation models.   A Nexel representative added, “We are focusing our pipeline on serious diseases with established market sizes such as liver disease, heart disease, pulmonary fibrosis, and ulcerative colitis, and we are expanding indications around diseases with high commercialization potential. Based on broad partnerships, Nexel pursues an efficient and flexible strategy that enables timely technology transfers and rapid results.”   Reporter Lee Sang-gyu
  • 2025-04-21

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EVENT

The 48th Workshop of The Korean Society of Non-Clinical Study (KSNS)

  •   NEXEL is excited to participate in the 48th Workshop of the Korean Society of Non-Clinical Study (KSNS), taking place at JEJU ICC!   Visit us at Booth #41 to explore the latest advancements in iPSC-based non-clinical testing and human-relevant research models.   As a leader in iPSC-derived technologies and next-generation NAMs (New Approach Methodologies), NEXEL is committed to transforming non-clinical research through innovation and collaboration.   At KSNS, we’ll be showcasing our comprehensive portfolio of: • hiPSC-derived cell and organoid platforms • Cardio-safety analysis services • Customized CDMO solutions — all designed to bridge the gap between non-clinical and clinical research.   If you’re attending the KSNS Workshop, we’d love to meet you!   Let’s discuss how NEXEL’s technologies can empower The Preeminent Clinical Studies from Distinguished Non-clinical Researches and accelerate your R&D goals.   ≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡   In the midst of a global economic paradigm shift and the revolution of knowledge and light, our society has entered a new era of communication and innovation. Even under unprecedented circumstances, our unwavering passion for new drug development has led to The Preeminent Clinical Studies from Distinguished Non-clinical Researches (青出於藍 靑於藍).   We are pleased to invite you to the 48th Workshop of the Korean Society of Toxicology, a gathering to celebrate and share our collective progress.   This year’s workshop is designed to provide a comprehensive overview of the latest trends and practical strategies in drug development.   Session 1 will explore new directions in global and domestic R&D strategies for Alzheimer’s disease therapeutics, focusing on innovative biotech platforms.   Session 2 will discuss translational approaches from non-clinical to clinical research, featuring case studies in MASH treatments, OX40L/TNFa agonists, immunocytokines, and rare disease therapeutics.   Sessions 3 & 4 will cover AI-driven drug discovery, biomarker strategies from the clinical researcher’s perspective, and CAR-T/Bispecific Ab–TPD-based modalities, encompassing both conceptual and practical insights for next-generation drug development.   Session 5 will highlight Althera’s ALT-B4 and VUNO’s VX-149 (Unafra®) case studies, emphasizing the transition from biologics to NDA success strategies. The Young Scientist Award will recognize the passion and growth of emerging researchers, while the T2B Satellite Session will share outcomes and future directions of translational research connecting bench to bedside.   Following the Dinner Seminar, a dedicated Social Networking Session will provide an opportunity for participants to exchange ideas, recognize each other’s efforts, and strengthen collaboration beyond the boundaries of their busy schedules.   This workshop also marks the conclusion of the 17th term of our Clinical Committee — a meaningful moment to reflect on the past two years of progress and to prepare for a renewed start with our valued members and colleagues. We extend our sincere gratitude for your continued passion and support, and we look forward to an inspiring gathering in Jeju this year.  
  • 2025-10-27

2025 SPS Annual Meeting

  •   NEXEL is heading to the SPS 2025 Annual Meeting!   Join us at the premier global conference for safety pharmacology, where scientists, regulators, and industry leaders gather to advance the science and practice of evaluating the safety of new drugs and chemicals.   As a pioneer in iPSC-based technologies and next-generation non-clinical testing, NEXEL will showcase: iPSC-derived cell products Cardio-safety analysis services Customized CDMO solutions   We’re redefining drug discovery and safety testing with human-relevant, animal-free models—enabling faster, safer, and more ethical innovation.   Visit us at Booth #213 to explore how NEXEL can empower your research and drive progress in the field of safety pharmacology.   ≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡≡   The Safety Pharmacology Society Annual Meeting is a must-attend event for anyone interested in drug discovery and the field of safety pharmacology.   This conference brings together experts from around the world to share the latest research and knowledge on the evaluation of the safety of new drugs and chemicals.   Attendees will have the opportunity to learn from renowned scientists, participate in educational sessions, and network with peers and leaders in the field.   Whether you are a seasoned professional or a student just starting out, the Safety Pharmacology Society Annual Meeting is an excellent opportunity to expand your knowledge and enhance your career in the field of safety pharmacology.  
  • 2025-10-02
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