Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs
Mesoblast (NASDAQ:MESO) has confirmed that its cell therapy products, including FDA-approved Ryoncil®, are manufactured in the United States from U.S. donors and designated as U.S. origin products. This designation means they are exempt from tariffs on imported branded or patented pharmaceutical products.
Ryoncil® stands as the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication, specifically approved for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older. The company maintains U.S.-based manufacturing for all its products, including treatments for chronic heart failure, chronic back pain, and other inflammatory conditions.
Mesoblast (NASDAQ:MESO) ha confermato che i propri prodotti di terapia cellulare, inclusa Ryoncil®, sono realizzati negli Stati Uniti da donatori statunitensi e designati come prodotti di origine americana. Questa designazione implica che sono esentati dai dazi sull'importazione di prodotti farmaceutici marchiati o coperti da brevetto. Ryoncil® è l'unica terapia allogenica a cellule stromali mesenchimali approvata dalla FDA per qualsiasi indicazione, specificamente autorizzata per trattare la malattia da rigetto allogena acuta refrattaria agli steroidi (SR-aGvHD) nei pazienti pediatrici di 2 mesi e oltre. L'azienda mantiene la produzione interamente basata negli Stati Uniti per tutti i suoi prodotti, inclusi trattamenti per insufficienza cardiaca cronica, dolore cronico alla schiena e altre condizioni infiammatorie.
Mesoblast (NASDAQ:MESO) ha confirmado que sus productos de terapia celular, incluido Ryoncil®, se fabrican en Estados Unidos a partir de donantes estadounidenses y se designan como productos de origen estadounidense. Esta designación significa que están exentos de aranceles sobre productos farmacéuticos importados de marca o protegidos por patente. Ryoncil® es la única terapia con células mesenquimales alogénicas aprobada por la FDA para cualquier indicación, específicamente aprobada para el tratamiento de la enfermedad injerto contra huésped aguda esteroidea-refractaria (SR-aGvHD) en pacientes pediátricos de 2 meses en adelante. La empresa mantiene la fabricación con base en EE. UU. para todos sus productos, incluidos tratamientos para insuficiencia cardíaca crónica, dolor crónico de espalda y otras condiciones inflamatorias.
Mesoblast (NASDAQ:MESO)은 FDA 승인된 Ryoncil®을 포함한 세포 치료 제품이 미국 내에서 미국 기증자로부터 제조되며 미국 기원 제품으로 지정되었다고 확인했습니다. 이 지정은 수입된 브랜드 또는 특허 의약품에 대한 관세가 면제됨을 의미합니다. Ryoncil®은 모든 적응증에 대해 FDA 승인된 동종 유래 간엽줄기세포 치료제로서, 특히 스테로이드를 반응하지 않는 급성 이식편대숙주질환(SR-aGvHD)을 2개월 이상 어린 환자에서 치료하도록 승인되었습니다. 이 회사는 만성 심부전, 만성 요통 및 기타 염증성 질환 치료를 포함한 모든 자사 제품에 대해 미국 내 제조를 유지합니다.
Mesoblast (NASDAQ:MESO) a confirmé que ses produits de thérapie cellulaire, y compris Ryoncil®, sont fabriqués aux États-Unis à partir de donneurs américains et désignés comme des produits d’origine américaine. Cette désignation signifie qu’ils bénéficient d’une exonération de droits de douane sur les produits pharmaceutiques importés sous marque ou protégés par brevet. Ryoncil® est la seule thérapie allogénique des cellules stromales mésenchymales approuvée par la FDA pour toute indication, spécifiquement approuvée pour traiter la maladie du greffon contre l’hôte aiguine résistante aux stéroïdes (SR-aGvHD) chez les patients pédiatriques âgés de 2 mois et plus. L’entreprise maintient une fabrication basée aux États-Unis pour tous ses produits, y compris les traitements de l’insuffisance cardiaque chronique, les douleurs lombaires chroniques et d’autres affections inflammatoires.
Mesoblast (NASDAQ:MESO) hat bestätigt, dass seine Zelltherapieprodukte, einschließlich der FDA-zugelassenen Ryoncil®, in den USA aus US-Spendern hergestellt und als US-Originalprodukte bezeichnet werden. Diese Bezeichnung bedeutet, dass sie von Zöllen auf importierte Marken- oder patentierte Arzneimittel befreit sind. Ryoncil® ist die einzige FDA-zugelassenen allogenen mesenchymalen Stammzelltherapien für irgendeine Indikation und speziell zugelassen zur Behandlung der steroidrefraktären akuten Graft-versus-Host-Krankheit (SR-aGvHD) bei pädiatrischen Patienten ab 2 Monaten. Das Unternehmen hält die in den USA basierte Herstellung für alle seine Produkte aufrecht, einschließlich Behandlungen für chronische Herzinsuffizienz, chronische Rückenschmerzen und andere entzündliche Erkrankungen.
Mesoblast (NASDAQ:MESO) قد أكدت أن منتجاتها من العلاجات الخلوية، بما في ذلك Ryoncil® المعتمد من الـ FDA، تُصنع في الولايات المتحدة من متبرعين أمريكيين وتُصنّف كمنتجات ذات أصل أمريكي. وهذا التصنيف يعني أنها معفاة من الرسوم الجمركية على الأدوية الصيدلانية المستوردة ذات العلامة التجارية أو المحمية ببراءة اختراع. Ryoncil® هي العلاج الوحيد-allogeneic الخلوي القائم على الخلايا الوسيطة المسببة للنمو المعتمد من FDA لأي استخدام، وموافق عليه تحديداً لعلاج مرض الرفض الناتج عن الزرع المناعي الحاد الذي يجف؟ SR-aGvHD عند مرضى أطفال بعمر شهرين فما فوق. تحتفظ الشركة بآلية التصنيع في الولايات المتحدة لجميع منتجاتها، بما في ذلك العلاجات لفشل القلب المزمن، الألم أسفل الظهر المزمن، وغيرها من الحالات الالتهابية.
Mesoblast（纳斯达克：MESO） 已确认其细胞治疗产品，包括获 FDA 批准的 Ryoncil®，均由美国捐献者在美国制造并被指定为美国原产产品。这一称号意味着它们在进口品牌或专利药品方面享有< b>关税豁免。Ryoncil® 是唯一获 FDA 批准的同种异体间充质干细胞治疗，用于任何适应症，专门获批用于治疗2个月及以上儿童患者的激素难治性急性移植物抗宿主病（SR-aGvHD）。公司对所有产品在美国保持就地生产，包括治疗慢性充血性心力衰竭、慢性腰痛及其他炎症性疾病。
- Ryoncil® designated as 'U.S. Country of Origin' product, avoiding import tariffs
- Only FDA-approved allogeneic mesenchymal stromal cell therapy in the market
- Established U.S.-based manufacturing infrastructure for all products
- None.
NEW YORK, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reiterated that its allogeneic cell therapy products are manufactured from U.S. donors in the U.S. and designated as U.S. origin products not subject to tariffs on imported branded or patented pharmaceutical products.
Ryoncil® (remestemcel-L) is the only allogeneic mesenchymal stromal cell therapy approved by U.S. Food and Drug Administration (FDA) for any indication. As documented in the Company’s Biologic License Application (BLA), Ryoncil® is designated a ‘U.S. Country of Origin’ product in line with U.S. FDA and Customs regulatory guidance.
Ryoncil® is approved for treatment of pediatric patients 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a condition with high mortality rates.
Mesoblast continues to ensure that all its products, whether for SR-aGvHD, chronic heart failure, chronic back pain, or other inflammatory indications, are manufactured from U.S. donors at U.S. sites.
About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.
Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.
About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets.
About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s Ryoncil® for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
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FAQ
What is the significance of Mesoblast's U.S. origin designation for its cell therapy products?
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