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- Datavault AI Inc.Datavault AI CEO to Present "Operating System for Tokenized Assets" at XRP Seoul 2026PHILADELPHIA, PA, Oct 2, 2026 - Datavault AI Inc. ("Datavault AI" or the "Company") (NASDAQ:DVLT), a provider of data monetization, credentialing, digital engagement, and real-world asset ("RWA") tokenization technologies, today announced that Nathaniel T. Bradley, CEO of Datavault AI, will present "Operating System for Tokenized Assets" at XRP Seoul 2026 on Oct. 3, 2026, at 3:05 p.m. KST at the Grand Hyatt Seoul in Seoul, South Korea. In the session, Bradley will explain why valuation, credentialing and verified metadata belong in a single operating layer beneath every real-world asset and how the Company's DataValue®, DataScore® and Information Data Exchange® technologies perform those functions in a single sequence beneath the point of issuance. "Tokenization gets treated as an issuance problem when it is really a data problem, and the Information Data Exchange exists to solve the data problem first," said Nathaniel T. Bradley, CEO of Datavault AI. "In Seoul, we will show the XRP Ledger community why valuation, credentialing and verified metadata have to live in one operating layer beneath the asset, and how our platform runs that sequence today." Bradley will also join the panel "How Traditional Finance Is Embracing Tokenization" at 5:40 p.m. KST. Datavault AI will exhibit at the conference and deploy its ADIO acoustic data transmission technology at its booth and from the keynote stage, where ADIO audio tones will direct attendees' mobile devices to registration and giveaway experiences. The Company's participation follows its appearances at XRP Tokyo 2026 and XRP Seoul 2025 and reflects its continued focus on expanding its presence and customer development across the Asia-Pacific region. Separately, Datavault AI will distribute the first XRP Seoul 2026 Limited Edition Collectible Token, a commemorative digital token minted on the XRP Ledger, to XRP Seoul 2026 attendees. The token is intended solely as a commemorative digital collectible for conference attendees and features a custom 3D design created for the event. Following Bradley's keynote, attendees can claim the token through the ADIO web app, which directs them to register or sign in to the Datavault AI platform, where the token is delivered to their account. "This is a historic first for XRP Seoul. We're thrilled to partner with Datavault AI to bring XRP Seoul's very first commemorative collectible to our attendees: a one-of-a-kind digital keepsake that marks a moment our global community will remember for years to come," said Ben Ko, Co-founder of XRPL Korea. About XRP Seoul 2026 XRP Seoul 2026 is a global conference focused on the XRP Ledger ecosystem, institutional blockchain adoption and real-world on-chain use cases. Hosted by XRPL Korea with Ripple as title sponsor, the event takes place on Oct. 3, 2026, at the Grand Hyatt Seoul. About Datavault AI Datavault AI™ (NASDAQ:DVLT) is leading the way in AI-driven data experiences, valuation, and monetization of assets in the Web 3.0 environment. The Company's cloud-based platform provides comprehensive solutions with a collaborative focus in its Acoustic Sciences and Data Sciences divisions. Datavault AI's Acoustic Sciences division features WiSA®, ADIO®, and Sumerian® patented technologies and industry-first foundational spatial and multichannel wireless, high-definition sound transmission technologies with intellectual property covering audio timing, synchronization, and multi-channel interference cancellation. The Data Science division leverages the power of Web 3.0 and high-performance computing to provide solutions for experiential data perception, valuation, and secure monetization. Datavault AI's platform serves multiple industries, including high-performance computing software licensing for sports & entertainment, events & venues, biotech, education, fintech, real estate, healthcare, energy, and more. The Information Data Exchange® enables Digital Twins and the licensing of name, image, and likeness by securely attaching physical real-world objects to immutable metadata, fostering responsible AI with integrity. The Company's technology suite is fully customizable and offers AI- and machine-learning-based automation, third-party integration, detailed analytics and data, marketing automation, and advertising monitoring. The Company is headquartered in Philadelphia, PA. Learn more about Datavault AI at https://dvlt.ai. Forward-Looking Statements This press release contains "forward-looking statements" (within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other securities laws) about Datavault AI Inc. ("Datavault AI," the "Company," "us," "our," or "we") and our industry that involve risks and uncertainties. In some cases, you can identify forward-looking statements because they contain words, such as "may," "might," "will," "shall," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential," "goal," "objective," "seeks," "likely," or "continue" or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. The absence of these words does not mean that a statement is not forward-looking. Such forward-looking statements, including, but not limited to, statements regarding future events, the planned creation of a commemorative digital token minted on the XRP Ledger and its distribution to XRP Seoul 2026 attendees through the ADIO web app and the Datavault AI platform, the anticipated presentation by the Company's CEO at XRP Seoul 2026 and the positions to be advanced in it, the described capabilities of the Company's DataValue, DataScore, and Information Data Exchange technologies and their application to real-world asset tokenization, the Company's planned exhibit presence, the planned deployment of ADIO acoustic data transmission technology at its booth and from the keynote stage, and the expected commercial relationships and customer development opportunities arising from the Company's Asia-Pacific expansion, are necessarily based upon estimates and assumptions that, while considered reasonable by the Company and its management, are inherently uncertain. Readers are cautioned not to place undue reliance on these and other forward-looking statements contained herein. Actual results may differ materially from those indicated by these forward-looking statements as a result of various risks and uncertainties including, but not limited to, the following: the Company's ability to create and distribute a commemorative digital token minted on the XRP Ledger to conference attendees through the ADIO web app and the Datavault AI platform as planned; the risk that the commemorative token is characterized by regulators as a security, virtual asset, or other regulated instrument in South Korea, the United States, or other jurisdictions; the Company's ability to present at and exhibit at XRP Seoul 2026 as planned; the Company's ability to deliver the described valuation, credentialing, and data exchange capabilities as a single operating layer for tokenized real-world assets; the Company's ability to deploy ADIO acoustic data transmission technology at the event venue; the Company's ability to convert event participation into commercial relationships or revenue in the Asia-Pacific region; changes in market demand for Datavault AI's services and products; changes in economic, market, or regulatory conditions; risks relating to evolving regulatory frameworks applicable to digital assets and tokenized assets in South Korea and other jurisdictions; risks associated with technological development and integration; and other risks and uncertainties as more fully described in Datavault AI's filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2025 and other filings that Datavault AI makes from time to time with the SEC, which are available on the SEC's website at www.sec.gov, and could cause actual results to vary from expectations. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. Datavault AI undertakes no obligation to update any forward-looking statements made in this press release to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. Datavault AI may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on such forward-looking statements. Datavault AI's forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments it may make. Industry and Market Data Within this press release, we reference information and statistics regarding the market for our products. We have obtained some of this information and statistics from various independent third-party sources, including independent industry publications, reports by market research firms, and other independent sources. Some data and other information contained in this press release are also based on management's estimates and calculations, which are derived from our review and interpretation of internal surveys and independent sources. Data regarding the industries in which we compete and our market position and market share within these industries are inherently imprecise and are subject to significant business, economic and competitive uncertainties beyond our control, but we believe they generally indicate size, position and market share within this industry. While we believe such information is reliable, we have not independently verified any third-party information. While we believe our internal company research and estimates are reliable, such research and estimates have not been verified by any independent source. In addition, assumptions and estimates of our and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors. These and other factors could cause our future performance to differ materially from our assumptions and estimates. As a result, you should be aware that market, ranking and other similar industry data included in this press release, and estimates and beliefs based on that data, may not be reliable. Trademarks, Trade Names, Service Marks and Copyrights We own or have rights to use various trademarks, tradenames, service marks and copyrights, which are protected under applicable intellectual property laws. This press release also contains trademarks, tradenames, service marks and copyrights of other companies, which are, to our knowledge, the property of their respective owners. Solely for convenience, certain trademarks, tradenames, service marks and copyrights referred to in this press release may appear without the ©, ®, and ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, tradenames, service marks and copyrights. We do not intend our use or display of other parties' trademarks, tradenames, service marks or copyrights to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties. Media Contact [email protected] Investor Contact Edward Barger VP, Investor Relations [email protected] © 2026 Datavault AI Inc. All Rights Reserved. SOURCE: Datavault AI Inc.
- Targeted Cancer Therapy Market Size and Forecast by Therapy Type, Disease Indication, End-User, and Region, 2026-2035 | Precision Oncology Drives 6.8% CAGR Toward $175.48 BillionPrecision oncology, ADC innovation and radiopharmaceutical acquisitions drive growth, while strong U.S. approvals and hospital demand reinforce expansion
- Global AI Medical Diagnosis App Market Size, Share, Trends, and Forecast to 2040 | Market to Reach $19.81 Billion at 20.9% CAGR as Cloud, Wearables, and Telemedicine ScaleMap investment hotspots and white spaces in AI diagnostics, leveraging regulatory momentum, wearables, telemedicine and explainable AI to drive scalable growth.
- Ascletis Pharma Inc.Ascletis' ASC36_35FDC Demonstrated Potential for Once-Monthly to Once-Quarterly Dosing and Robust Weight-Loss in Preclinical Studies Presented at EASD 2026Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announced the presentation of key preclinical data for its ASC36_35FDC (ASC36_35 co-formulation) at the 62nd European Association for the Study of Diabetes (EASD) Annual Meeting, being held...
- PhytoHealth CEO Angel Lee Recognized for Driving the Advancement of World's First Prescription Drug for Cancer-Related FatigueRecognition highlights PhytoHealth's work in advancing PG2®, Taiwan's first approved botanical new drug, and raising clinical awareness of cancer-related fatigue — PhytoHealth Corporation CEO Angel Lee has been named one of Taiwan's 27th Ten Outstanding...
- Everest Medicines Announces the Acceptance and Priority Review of VELSIPITY(R) Manufacturing Localization Application by the Center for Drug Evaluation of China's NMPA, Driving Continued Commercial MomentumHong Kong, Oct 2, 2026 - Everest Medicines recently announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the application for localized manufacturing for VELSIPITY(R) (etrasimod arginine tablets) and granted Priority Review. Localized manufacturing of VELSIPITY(R) is expected to begin in 2027, further enhancing supply capacity and supply security in China and across the Asia-Pacific region. The acceptance marks progress in the Company’s planned commercialization of VELSIPITY(R). The VELSIPITY(R) localized production project has been progressing steadily since its launch at the Company’s global manufacturing facility in Jiashan in March 2025, with ongoing efforts focused on technology transfer, process optimization and preparations for localized manufacturing. Upon commencement of production, the facility is expected to have an annual production capacity of up to 50 million tablets, helping to strengthen supply stability, reduce manufacturing costs and improve operational efficiency, while supporting the commercialization of VELSIPITY(R). VELSIPITY(R) was approved by NMPA in February, 2026, for the treatment of adult patients with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. As a next-generation highly selective S1P receptor modulator, VELSIPITY(R) offers the potential for rapid onset of action, and long-lasting clinical remission and mucosal healing through an oral, once-daily regimen for adult patients with moderately to severely active UC. The first prescription of VELSIPITY(R) in China was issued in March 2026, making its entry into clinical use. Alongside its rapid commercialization, the Company is actively participating in negotiations for the inclusion of VELSIPITY(R) in the National Reimbursement Drug List (NRDL). VELSIPITY(R) has been approved in several territories licensed to Everest Medicines, including mainland China, Hong Kong SAR, Macao SAR, Singapore, and South Korea, and is expected to receive NDA approval in Taiwan, China in the second half of 2026. On the clinical front, Ulcerative colitis (UC) is a chronic, relapsing, non-specific inflammatory bowel disease. In China, the incidence and prevalence of UC continue to increase, with a clear trend toward younger patients. The patient population is projected to increase from approximately 0.98 million in 2025 to 1.50 million by 20311,2. Multiple studies of VELSIPITY(R) presented at the 21st Congress of the European Crohn’s and Colitis Organization (ECCO 2026) and the 14th Annual Meeting of the Asian Organization for Crohn’s and Colitis (AOCC 2026) further supported its clinical profile. The data demonstrated sustained efficacy with continuous treatment for up to 3 years3. Durable benefit was observed in patients who had received only 5-ASA/thiopurine treatment, and in biologic-experienced patients4,5. Benefit was also demonstrated in patients with mildly to moderately active UC6, with favorable long-term safety and tolerability maintained for up to 5 years of treatment7. These findings further strengthen the clinical evidence base of VELSIPITY(R). The clinical value of VELSIPITY(R) has been recognized in leading international clinical guidelines. Following its inclusion in the American Gastroenterological Association (AGA) Clinical Practice Guideline in December 2024 as a first-line treatment for ulcerative colitis, VELSIPITY(R) was also included in the 2025 American College of Gastroenterology (ACG) Clinical Guideline, the 2026 Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines and the 2026 European Crohn's and Colitis Organization (ECCO) Guidelines. Everest Medicines has a commercial-scale global manufacturing site in Jiashan, Zhejiang Province. It has established a complete GMP production quality management system complying with Chinese, EU and WHO standards and holds the manufacturing license. Localized manufacturing is expected to further enhance the commercial potential of VELSIPITY(R) by improving supply reliability and operational efficiency in China. Supported by Everest Medicines’ A2MS commercial operating system and lean management capabilities, the localized production of VELSIPITY(R) will strengthen the foundation for its continued expansion in China and further build the Company’s commercial capabilities in autoimmune diseases, supporting its long-term growth. Reference1. Shao B, et al. Front Public Health. 2022 Oct 25;10:1032679.2. Kaplan GG. Nat Rev Gastroenterol Hepatol. 2015;12(12):720-727.3. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.774.4. B E Sands, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1105.5. C Zheng, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1046.6. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.100.7. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1256.
- CaseBioscience® rejoint l'équipe qui s'est vu attribuer jusqu'à 7,3 millions de dollars par l'ARPA-H pour faire progresser la conservation à température ambiante des thérapies cellulairesFORT COLLINS, Colorado, 2 octobre 2026 -- CaseBioscience® a annoncé aujourd'hui sa participation à une équipe pluridisciplinaire dirigée par Likarda, à qui l'Advanced Research Projects Agency for Health (ARPA-H) a octroyé jusqu'à 7,3 millions de dollars dans le cadre de son...
- Lundbeck to showcase progress across its movement disorders pipeline with data in multiple system atrophy and Parkinson's disease at MDS® 2026Late-breaking Phase III MASCOT oral presentation will characterize the clinical profile and diversity of participants in Lundbeck's ongoing global Phase III trial investigating amlenetug in multiple system atrophy (MSA) New research across clinical trial endpoints, biomarkers, diagnostic...
- SkanskaSkanska signs additional contract for new hospital in Fort Myers, Florida, USA, for USD 60M, about SEK 560MSkanska has signed an additional contract with Lee Health for the construction of a new hospital and medical office building in Fort Myers, Florida, USA. The additional contract is worth USD 60M, about SEK 560M, which will be included in the US...
- 雲頂新耀宣佈維適平(R)由境外轉移至境內生產的藥品上市註冊申請獲國家藥品監督管理局藥品審評中心受理並納入優先審評審批程序，商業化佈局持續推進香港, 2026年10月2日 - 雲頂新耀近日宣佈中國國家藥品監督管理局（NMPA）藥品審評中心（CDE）已受理維適平(R)（精氨酸艾曲莫德片，VELSIPITY(R)）由境外轉移至境內生產的藥品上市註冊申請，並納入優先審評審批程序。維適平(R)本地化生產有望於2027年正式投產，將進一步提升其在中國及亞太市場的供應能力，增強供應保障。此次獲受理是維適平(R)商業化戰略按計劃推進的重要進展。 維適平(R)生產建設項目自2025年3月在雲頂新耀位於嘉善的全球生產基地啟動以來，持續推進生產技術轉移、工藝優化及地產化生產準備工作。正式投產後預計年產能最高可達5,000萬片，將有助於提升產品供應的穩定性，降低生產成本，提高運營效率，支持維適平(R)的商業化發展。 維適平(R)於2026年2月獲NMPA批准上市，用於治療對傳統治療或生物製劑應答不充分、失應答或不耐受的中度至重度活動性潰瘍性結腸炎（UC）成人患者。作為新一代高選擇性S1P受體調節劑，維適平(R)每日一次口服，可實現快速起效和強效深度黏膜癒合，並具有良好的安全性特徵，具備最佳藥物（best-in-disease）潛質，為成人潰瘍性結腸炎患者提供新的一線治療選擇。2026年3月維適平(R)開出首張處方，正式進入中國臨床應用階段。在快速實現商業化落地的同時，維適平(R)積極參與國家醫保目錄談判。 截止目前，在雲頂新耀授權區域內，維適平(R)已在中國大陸、中國香港、中國澳門、新加坡及韓國獲得新藥上市批准，並有望於2026年下半年在中國台灣地區獲批上市。 臨床需求方面，潰瘍性結腸炎（UC）是一種病因尚不明確、易復發的慢性腸道炎症性疾病。近年來，中國潰瘍性結腸炎發病率持續上升，並呈現年輕化趨勢，預計患者人數將由2025年的約98萬增長至2031年的約150萬1,2。 在第21屆歐洲克羅恩病和結腸炎組織大會（ECCO 2026）和第14屆亞洲克羅恩病和結腸炎組織年會（AOCC 2026）中公佈的多項維適平(R)最新成果顯示：持續用藥3年可維持長期且穩定療效3；僅接受過5-ASA/硫嘌呤傳統治療的患者、生物製劑經治人群均可持續獲益4,5；輕中度UC患者展現出治療獲益6；同時5年長期安全性和耐受性良好7。這些研究結果進一步豐富了維適平(R)的循證醫學證據。 維適平(R)的臨床價值已獲得多項國際權威指南的充分認可。該藥物被納入2024年美國胃腸病協會（AGA）指南、2025年美國胃腸病學會（ACG）指南、2026年亞太胃腸病學會（APAGE）指南和2026年歐洲克羅恩病和結腸炎組織（ECCO）指南等多個國際指南推薦，推薦作為潰瘍性結腸炎的一線治療。 雲頂新耀在浙江嘉善擁有具備商業化規模的全球生產基地，其佔地面積為85畝，建築面積為58,000平方米，依據中國、歐盟和WHO標準建立了完善的GMP生產質量管理體系，並已獲得中國藥監局頒發的生產許可證。 此次維適平(R)地產化申請獲受理並納入優先審評審批，是雲頂新耀圍繞公司既定戰略，推進產品商業化的又一實質性進展。維適平(R)憑藉差異化優勢，被業界認為有望填補當前潰瘍性結腸炎治療缺口。依託「A2MS」商業化運營體系及精益管理體系，雲頂新耀可通過本地化生產有效破解進口藥品供應週期長、成本高等痛點，全面提升藥品全生命週期商業化能力。隨著產品商業化落地與醫保准入的推進，這一產業化部署將持續鞏固雲頂新耀在自身免疫領域的商業化競爭壁壘，為公司長期高質量發展注入強勁動力。 參考文獻 1. Shao B, et al. Front Public Health. 2022;10:1032679. 2. Kaplan GG. Nat Rev Gastroenterol Hepatol. 2015;12(12):720-727. 3. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.774. 4. B E Sands, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1105. 5. C Zheng, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1046. 6. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.100. 7. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1256.
- Everest Medicines Announces the Acceptance and Priority Review of VELSIPITY(R) Manufacturing Localization Application by the Center for Drug Evaluation of China's NMPA, Driving Continued Commercial MomentumHong Kong, Oct 2, 2026 - Everest Medicines recently announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the application for localized manufacturing for VELSIPITY(R) (etrasimod arginine tablets) and granted Priority Review. Localized manufacturing of VELSIPITY(R) is expected to begin in 2027, further enhancing supply capacity and supply security in China and across the Asia-Pacific region. The acceptance marks progress in the Company’s planned commercialization of VELSIPITY(R). The VELSIPITY(R) localized production project has been progressing steadily since its launch at the Company’s global manufacturing facility in Jiashan in March 2025, with ongoing efforts focused on technology transfer, process optimization and preparations for localized manufacturing. Upon commencement of production, the facility is expected to have an annual production capacity of up to 50 million tablets, helping to strengthen supply stability, reduce manufacturing costs and improve operational efficiency, while supporting the commercialization of VELSIPITY(R). VELSIPITY(R) was approved by NMPA in February, 2026, for the treatment of adult patients with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. As a next-generation highly selective S1P receptor modulator, VELSIPITY(R) offers the potential for rapid onset of action, and long-lasting clinical remission and mucosal healing through an oral, once-daily regimen for adult patients with moderately to severely active UC. The first prescription of VELSIPITY(R) in China was issued in March 2026, making its entry into clinical use. Alongside its rapid commercialization, the Company is actively participating in negotiations for the inclusion of VELSIPITY(R) in the National Reimbursement Drug List (NRDL). VELSIPITY(R) has been approved in several territories licensed to Everest Medicines, including mainland China, Hong Kong SAR, Macao SAR, Singapore, and South Korea, and is expected to receive NDA approval in Taiwan, China in the second half of 2026. On the clinical front, Ulcerative colitis (UC) is a chronic, relapsing, non-specific inflammatory bowel disease. In China, the incidence and prevalence of UC continue to increase, with a clear trend toward younger patients. The patient population is projected to increase from approximately 0.98 million in 2025 to 1.50 million by 20311,2. Multiple studies of VELSIPITY(R) presented at the 21st Congress of the European Crohn’s and Colitis Organization (ECCO 2026) and the 14th Annual Meeting of the Asian Organization for Crohn’s and Colitis (AOCC 2026) further supported its clinical profile. The data demonstrated sustained efficacy with continuous treatment for up to 3 years3. Durable benefit was observed in patients who had received only 5-ASA/thiopurine treatment, and in biologic-experienced patients4,5. Benefit was also demonstrated in patients with mildly to moderately active UC6, with favorable long-term safety and tolerability maintained for up to 5 years of treatment7. These findings further strengthen the clinical evidence base of VELSIPITY(R). The clinical value of VELSIPITY(R) has been recognized in leading international clinical guidelines. Following its inclusion in the American Gastroenterological Association (AGA) Clinical Practice Guideline in December 2024 as a first-line treatment for ulcerative colitis, VELSIPITY(R) was also included in the 2025 American College of Gastroenterology (ACG) Clinical Guideline, the 2026 Asian Pacific Association of Gastroenterology (APAGE) Clinical Practice Guidelines and the 2026 European Crohn's and Colitis Organization (ECCO) Guidelines. Everest Medicines has a commercial-scale global manufacturing site in Jiashan, Zhejiang Province. It has established a complete GMP production quality management system complying with Chinese, EU and WHO standards and holds the manufacturing license. Localized manufacturing is expected to further enhance the commercial potential of VELSIPITY(R) by improving supply reliability and operational efficiency in China. Supported by Everest Medicines’ A2MS commercial operating system and lean management capabilities, the localized production of VELSIPITY(R) will strengthen the foundation for its continued expansion in China and further build the Company’s commercial capabilities in autoimmune diseases, supporting its long-term growth. Reference 1. Shao B, et al. Front Public Health. 2022 Oct 25;10:1032679. 2. Kaplan GG. Nat Rev Gastroenterol Hepatol. 2015;12(12):720-727. 3. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.774. 4. B E Sands, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1105. 5. C Zheng, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1046. 6. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.100. 7. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1256.
- 云顶新耀宣布维适平(R)由境外转移至境内生产的药品上市注册申请获国家药品监督管理局药品审评中心受理并纳入优先审评审批程序，商业化布局持续推进香港, 2026年10月2日 - (亚太商讯) - 云顶新耀近日宣布中国国家药品监督管理局（NMPA）药品审评中心（CDE）已受理维适平(R)（精氨酸艾曲莫德片，VELSIPITY(R)）由境外转移至境内生产的药品上市注册申请，并纳入优先审评审批程序。维适平(R)本地化生产有望于2027年正式投产，将进一步提升其在中国及亚太市场的供应能力，增强供应保障。此次获受理是维适平(R)商业化战略按计划推进的重要进展。 维适平(R)生产建设项目自2025年3月在云顶新耀位于嘉善的全球生产基地启动以来，持续推进生产技术转移、工艺优化及地产化生产准备工作。正式投产后预计年产能最高可达5,000万片，将有助于提升产品供应的稳定性，降低生产成本，提高运营效率，支持维适平(R)的商业化发展。 维适平(R)于2026年2月获NMPA批准上市，用于治疗对传统治疗或生物制剂应答不充分、失应答或不耐受的中度至重度活动性溃疡性结肠炎（UC）成人患者。作为新一代高选择性S1P受体调节剂，维适平(R)每日一次口服，可实现快速起效和强效深度黏膜愈合，并具有良好的安全性特征，具备最佳药物（best-in-disease）潜质，为成人溃疡性结肠炎患者提供新的一线治疗选择。2026年3月维适平(R)开出首张处方，正式进入中国临床应用阶段。在快速实现商业化落地的同时，维适平(R)积极参与国家医保目录谈判。 截止目前，在云顶新耀授权区域内，维适平(R)已在中国大陆、中国香港、中国澳门、新加坡及韩国获得新药上市批准，并有望于2026年下半年在中国台湾地区获批上市。 临床需求方面，溃疡性结肠炎（UC）是一种病因尚不明确、易复发的慢性肠道炎症性疾病。近年来，中国溃疡性结肠炎发病率持续上升，并呈现年轻化趋势，预计患者人数将由2025年的约98万增长至2031年的约150万1,2。 在第21届欧洲克罗恩病和结肠炎组织大会（ECCO 2026）和第14届亚洲克罗恩病和结肠炎组织年会（AOCC 2026）中公布的多项维适平(R)最新成果显示：持续用药3年可维持长期且稳定疗效3；仅接受过5-ASA/硫嘌呤传统治疗的患者、生物制剂经治人群均可持续获益4,5；轻中度UC患者展现出治疗获益6；同时5年长期安全性和耐受性良好7。这些研究结果进一步丰富了维适平(R)的循证医学证据。 维适平(R)的临床价值已获得多项国际权威指南的充分认可。该药物被纳入2024年美国胃肠病协会（AGA）指南、2025年美国胃肠病学会（ACG）指南、2026年亚太胃肠病学会（APAGE）指南和2026年欧洲克罗恩病和结肠炎组织（ECCO）指南等多个国际指南推荐，推荐作为溃疡性结肠炎的一线治疗。 云顶新耀在浙江嘉善拥有具备商业化规模的全球生产基地，其占地面积为85亩，建筑面积为58,000平方米，依据中国、欧盟和WHO标准建立了完善的GMP生产质量管理体系，并已获得中国药监局颁发的生产许可证。 此次维适平(R)地产化申请获受理并纳入优先审评审批，是云顶新耀围绕公司既定战略，推进产品商业化的又一实质性进展。维适平(R)凭借差异化优势，被业界认为有望填补当前溃疡性结肠炎治疗缺口。依托“A2MS”商业化运营体系及精益管理体系，云顶新耀可通过本地化生产有效破解进口药品供应周期长、成本高等痛点，全面提升药品全生命周期商业化能力。随着产品商业化落地与医保准入的推进，这一产业化部署将持续巩固云顶新耀在自身免疫领域的商业化竞争壁垒，为公司长期高质量发展注入强劲动力。 参考文献 1. Shao B, et al. Front Public Health. 2022;10:1032679. 2. Kaplan GG. Nat Rev Gastroenterol Hepatol. 2015;12(12):720-727. 3. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.774. 4. B E Sands, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1105. 5. C Zheng, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1046. 6. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.100. 7. D T Rubin, et al. Journal of Crohn's and Colitis, 2026, jjaf231.1256. Copyright 2026 亚太商讯. All rights reserved. www.acnnewswire.com