Water Tower Research Underscores Ainos' Partnership With Taiwan Tanabe Seiyaku for VELDONA Manufacturing and Marketing
Ainos (NASDAQ:AIMD) has formed a strategic partnership with Taiwan Tanabe Seiyaku, a Mitsubishi Tanabe Pharma subsidiary, for manufacturing and marketing VELDONA® in Taiwan. The partnership focuses on advancing VELDONA®, a therapeutic candidate for primary Sjögren's syndrome.
The collaboration leverages Taiwan Tanabe Seiyaku's PIC/S GMP-certified facility and expertise in drug manufacturing and market promotion. A clinical study of VELDONA® has received Institutional Review Board approval from Shuang Ho Hospital, with site initiation planned for April 2025 and completion expected in December 2026. Previous U.S. Phase 3 studies showed VELDONA® benefits in improving oral dryness and salivary function for Sjögren's syndrome, an autoimmune disease affecting 0.1-1.0% of the global population.
Ainos (NASDAQ:AIMD) ha formato una partnership strategica con Taiwan Tanabe Seiyaku, una filiale di Mitsubishi Tanabe Pharma, per la produzione e la commercializzazione di VELDONA® a Taiwan. La partnership si concentra sullo sviluppo di VELDONA®, un candidato terapeutico per la sindrome di Sjögren primaria.
La collaborazione sfrutta la struttura certificata PIC/S GMP di Taiwan Tanabe Seiyaku e la sua esperienza nella produzione di farmaci e nella promozione sul mercato. Uno studio clinico di VELDONA® ha ricevuto l'approvazione del Comitato Etico dell'Ospedale Shuang Ho, con l'inizio previsto per aprile 2025 e il completamento atteso per dicembre 2026. Precedenti studi di Fase 3 negli Stati Uniti hanno dimostrato i benefici di VELDONA® nel migliorare la secchezza orale e la funzione salivare nella sindrome di Sjögren, una malattia autoimmune che colpisce lo 0,1-1,0% della popolazione globale.
Ainos (NASDAQ:AIMD) ha formado una asociación estratégica con Taiwan Tanabe Seiyaku, una subsidiaria de Mitsubishi Tanabe Pharma, para la fabricación y comercialización de VELDONA® en Taiwán. La asociación se centra en avanzar en VELDONA®, un candidato terapéutico para el síndrome de Sjögren primario.
La colaboración aprovecha la instalación certificada PIC/S GMP de Taiwan Tanabe Seiyaku y su experiencia en la fabricación de medicamentos y promoción en el mercado. Un estudio clínico de VELDONA® ha recibido la aprobación del Consejo de Revisión Institucional del Hospital Shuang Ho, con la iniciación del sitio planificada para abril de 2025 y la finalización esperada en diciembre de 2026. Estudios previos de Fase 3 en EE.UU. mostraron que VELDONA® tiene beneficios en la mejora de la sequedad oral y la función salival en el síndrome de Sjögren, una enfermedad autoinmunitaria que afecta entre el 0,1 y el 1,0% de la población global.
Ainos (NASDAQ:AIMD)는 대만 다나베 제약(Mitsubishi Tanabe Pharma)의 자회사인 대만 다나베 제약과 전략적 파트너십을 체결하여 대만에서 VELDONA®의 제조 및 마케팅을 진행합니다. 이 파트너십은 원발성 쇼그렌 증후군에 대한 치료 후보물질인 VELDONA®의 발전에 중점을 두고 있습니다.
협업은 대만 다나베 제약의 PIC/S GMP 인증 시설과 의약품 제조 및 시장 홍보 분야의 전문 지식을 활용합니다. VELDONA®의 임상 연구는 슈앙 호 병원의 기관 심사위원회 승인을 받았으며, 현장 시작은 2025년 4월로 예정되어 있으며, 완료는 2026년 12월로 예상됩니다. 이전 미국의 3상 연구에서는 VELDONA®가 쇼그렌 증후군으로 인한 구강 건조 및 타액 기능 개선에 도움이 되는 것으로 나타났습니다. 이 자가 면역 질환은 전 세계 인구의 0.1-1.0%에 영향을 미칩니다.
Ainos (NASDAQ:AIMD) a formé un partenariat stratégique avec Taiwan Tanabe Seiyaku, une filiale de Mitsubishi Tanabe Pharma, pour la fabrication et la commercialisation de VELDONA® à Taïwan. Ce partenariat vise à faire avancer VELDONA®, un candidat thérapeutique pour le syndrome de Sjögren primaire.
La collaboration tire parti des installations certifiées PIC/S GMP de Taiwan Tanabe Seiyaku et de son expertise en fabrication de médicaments et en promotion sur le marché. Une étude clinique sur VELDONA® a reçu l'approbation du comité d'éthique de l'hôpital Shuang Ho, avec le début de l'étude prévu pour avril 2025 et l'achèvement attendu en décembre 2026. Les précédentes études de phase 3 aux États-Unis ont montré que VELDONA® présente des avantages pour l'amélioration de la sécheresse buccale et de la fonction salivaire dans le syndrome de Sjögren, une maladie auto-immune touchant 0,1 à 1,0 % de la population mondiale.
Ainos (NASDAQ:AIMD) hat eine strategische Partnerschaft mit Taiwan Tanabe Seiyaku, einer Tochtergesellschaft von Mitsubishi Tanabe Pharma, zur Herstellung und Vermarktung von VELDONA® in Taiwan gegründet. Die Partnerschaft konzentriert sich auf die Weiterentwicklung von VELDONA®, einem therapeutischen Kandidaten für das primäre Sjögren-Syndrom.
Die Zusammenarbeit nutzt die PIC/S GMP-zertifizierte Einrichtung von Taiwan Tanabe Seiyaku und deren Expertise in der Arzneimittelherstellung und Marktvermarktung. Eine klinische Studie zu VELDONA® hat die Genehmigung der Ethikkommission des Shuang Ho Hospital erhalten, mit einem geplanten Beginn im April 2025 und einem voraussichtlichen Abschluss im Dezember 2026. Frühere US-Studien der Phase 3 zeigten, dass VELDONA® Vorteile bei der Verbesserung der Mundtrockenheit und der Speicheldrüsenfunktion bei Sjögren-Syndrom hat, einer Autoimmunerkrankung, die 0,1-1,0 % der Weltbevölkerung betrifft.
- Strategic partnership with Taiwan Tanabe Seiyaku, a subsidiary of Mitsubishi Tanabe Pharma, for manufacturing and marketing
- Access to PIC/S GMP-certified manufacturing facility
- Clinical trial approval received from Institutional Review Board
- Positive Phase 3 study results for VELDONA® in treating Sjögren's syndrome
- Clinical trials won't begin until April 2025
- Study completion not expected until December 2026, indicating a long timeline to potential commercialization
Insights
The partnership between Ainos and Taiwan Tanabe Seiyaku represents a significant milestone in VELDONA®'s development pathway. The PIC/S GMP-certified manufacturing facility adds credibility and ensures quality production standards essential for regulatory compliance. The planned clinical trial starting in 2025 at Shuang Ho Hospital will be important for validating VELDONA®'s efficacy in treating Sjögren's syndrome.
The market opportunity is substantial, with Sjögren's syndrome affecting
However, investors should note that the 2025-2026 timeline for the upcoming trial indicates that significant revenue generation is still years away. The partnership with Taiwan Tanabe Seiyaku's parent company, Mitsubishi Tanabe Pharma, could accelerate international market access if clinical trials prove successful.
The strategic partnership significantly enhances Ainos' commercialization prospects in the Asian market. Taiwan Tanabe Seiyaku's established presence in autoimmune therapeutics and connection to Mitsubishi Tanabe Pharma provides valuable distribution channels and market expertise. For a small-cap company with a market cap of
The agreement demonstrates strong commercial validation for VELDONA® and could serve as a template for future regional partnerships. The focus on Taiwan as an initial market is strategic, given its well-developed healthcare system and potential as a springboard for broader Asian market entry. The partnership structure, starting with a memorandum of understanding, suggests careful risk management while maintaining flexibility for future developments.
SAN DIEGO, CA / ACCESSWIRE / December 4, 2024 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), an innovative healthcare company focused on advanced AI-driven point-of-care testing ("POCT") and low-dose interferon therapeutics, today announced that Water Tower Research has issued a report highlighting Ainos' strategic partnership with Taiwan Tanabe Seiyaku for manufacturing and marketing VELDONA®, a novel therapeutic candidate for primary Sjögren's syndrome, in Taiwan.
The report underscores the significance of Ainos' efforts to out-license VELDONA®, starting with this key regional partnership, and sets the stage for future global expansion.
Key Highlights from the Report:
Key regional partnership: Ainos has entered into a memorandum of understanding with Taiwan Tanabe Seiyaku, a subsidiary of Mitsubishi Tanabe Pharma, to advance VELDONA®'s development and commercialization in Taiwan. This partnership leverages Taiwan Tanabe Seiyaku's expertise in drug manufacturing and market promotion, providing a strong launchpad for Ainos' out-licensing strategy.
Establishing foundation for a global footprint: Taiwan Tanabe Seiyaku operates a PIC/S GMP-certified facility, ensuring high-quality drug manufacturing, in addition to commercializing therapeutics for autoimmune, cardiovascular, and metabolic diseases. The parent company, Mitsubishi Tanabe Pharma, has a global presence, offering opportunities to expand VELDONA®'sreach beyond Taiwan into international markets.
VELDONA® Sjogren's trial to begin in 2025：Ainos has received Institutional Review Board approval from the Shuang Ho Hospital (Taipei Medical University) for a clinical study of VELDONA®. Approval of Taiwan Food and Drug Administration is anticipated in the next quarter, with site initiation visit planned for April 2025 and completion expected in December 2026.
Addressing unmet medical needs: Sjogren's syndrome is a chronic autoimmune disease affecting exocrine glands, with no curative treatments currently available. Global prevalence estimates vary from 0.1
-1.0% , mainly affecting middle-aged women starting at ages 45-55.Clinical evidence supporting VELDONA®: Previous U.S. Phase 3 studies demonstrated VELDONA® benefits in improving oral dryness and salivary function.
Link to the WTR report
About Ainos, Inc.
Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and low-dose interferon therapeutics (VELDONA®). The Company's clinical-stage product pipeline includes VELDONA® human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform. The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com. Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.
Safe Harbor Statement
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements.
Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the products announced in this press release; the Company's dependence on projected revenues from the sale of current or future products; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the accuracy of third-party market research data, the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2023, and other public filings with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's filings with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.
The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.
Contact Information
Feifei Shen
ir@ainos.com
SOURCE: Ainos, Inc.
View the original press release on accesswire.com
FAQ
When will Ainos (AIMD) begin clinical trials for VELDONA in Taiwan?
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