Meiji Seika Pharma Receives Approval for Adding Domestic Manufacturing Sites in Japan for KOSTAIVE®, a Self-amplifying mRNA Vaccine Against COVID-19
Meiji Seika Pharma has received approval to add domestic manufacturing sites in Japan for KOSTAIVE®, their self-amplifying mRNA COVID-19 vaccine. The approval enables integrated production within Japan, with ARCALIS's Minami-soma facilities and Meiji Seika Pharmatech added as manufacturing sites.
The technology transfer was managed by CSL Seqirus, the global licensor of KOSTAIVE®. The domestic production includes manufacturing of active pharmaceutical ingredients at ARCALIS's facilities and formulation at Meiji Seika Pharmatech, allowing for commercial distribution in Japan. This development involves Arcturus Therapeutics' LUNAR® lipid nanoparticle formulation processes and STARR® sa-mRNA drug substance manufacturing technologies.
Meiji Seika Pharma ha ricevuto l'approvazione per aggiungere siti di produzione domestica in Giappone per KOSTAIVE®, il loro vaccino COVID-19 a mRNA auto-amplificato. L'approvazione consente una produzione integrata all'interno del Giappone, con le strutture di ARCALIS a Minami-soma e Meiji Seika Pharmatech aggiunte come siti di produzione.
Il trasferimento tecnologico è stato gestito da CSL Seqirus, il licenziante globale di KOSTAIVE®. La produzione domestica include la fabbricazione di principi attivi farmaceutici presso le strutture di ARCALIS e la formulazione presso Meiji Seika Pharmatech, consentendo una distribuzione commerciale in Giappone. Questo sviluppo coinvolge i processi di formulazione nanoparticellare lipidica LUNAR® di Arcturus Therapeutics e le tecnologie di fabbricazione di sostanze attive sa-mRNA STARR®.
Meiji Seika Pharma ha recibido la aprobación para agregar sitios de fabricación nacional en Japón para KOSTAIVE®, su vacuna COVID-19 de ARNm auto-amplificante. La aprobación permite la producción integrada dentro de Japón, con las instalaciones de ARCALIS en Minami-soma y Meiji Seika Pharmatech añadidas como sitios de producción.
La transferencia de tecnología fue gestionada por CSL Seqirus, el licenciante global de KOSTAIVE®. La producción nacional incluye la fabricación de ingredientes farmacéuticos activos en las instalaciones de ARCALIS y la formulación en Meiji Seika Pharmatech, lo que permite la distribución comercial en Japón. Este desarrollo involucra los procesos de formulación de nanopartículas lipídicas LUNAR® de Arcturus Therapeutics y las tecnologías de fabricación de sustancias activas sa-mRNA STARR®.
메이지 세이카 제약은 자가 증폭 mRNA COVID-19 백신인 KOSTAIVE®의 일본 내 제조 사이트 추가 승인을 받았습니다. 해당 승인은 일본 내 통합 생산을 가능하게 하며, 미나미소마의 ARCALIS 시설과 메이지 세이카 제약 기술이 제조 사이트로 추가되었습니다.
기술 이전은 CSL Seqirus에 의해 관리되었으며, 이는 KOSTAIVE®의 글로벌 라이센서입니다. 국내 생산에는 ARCALIS 시설에서의 활성 제약 원료 제조와 메이지 세이카 제약 기술에서의 조제가 포함되어 일본 내 상업 배급을 가능하게 합니다. 이 개발에는 Arcturus Therapeutics의 LUNAR® 지질 나노입자 조제 과정과 STARR® sa-mRNA 의약품 제조 기술이 포함됩니다.
Meiji Seika Pharma a reçu l'approbation pour ajouter des sites de fabrication nationaux au Japon pour KOSTAIVE®, leur vaccin COVID-19 à ARNm auto-amplificateur. L'approbation permet une production intégrée au Japon, avec les installations d'ARCALIS à Minami-soma et Meiji Seika Pharmatech ajoutées en tant que sites de fabrication.
Le transfert de technologie a été géré par CSL Seqirus, le licencié mondial de KOSTAIVE®. La production nationale comprend la fabrication d'ingrédients pharmaceutiques actifs dans les installations d'ARCALIS et la formulation chez Meiji Seika Pharmatech, permettant ainsi une distribution commerciale au Japon. Ce développement implique les processus de formulation de nanoparticules lipidiques LUNAR® d'Arcturus Therapeutics et les technologies de fabrication de substances médicamenteuses sa-mRNA STARR®.
Meiji Seika Pharma hat die Genehmigung erhalten, in Japan nationale Produktionsstandorte für KOSTAIVE®, ihren selbstverstärkenden mRNA COVID-19-Impfstoff, hinzuzufügen. Die Genehmigung ermöglicht die integrierte Produktion innerhalb Japans, wobei die Einrichtungen von ARCALIS in Minami-Soma und Meiji Seika Pharmatech als Produktionsstandorte hinzugefügt wurden.
Der Technologietransfer wurde von CSL Seqirus verwaltet, dem globalen Lizenzgeber von KOSTAIVE®. Die nationale Produktion umfasst die Herstellung von aktiven pharmazeutischen Inhaltsstoffen in den Einrichtungen von ARCALIS und die Formulierung in Meiji Seika Pharmatech, was eine kommerzielle Verteilung in Japan ermöglicht. Diese Entwicklung beinhaltet die LUNAR® Lipid-Nanopartikel-Formulierungsprozesse von Arcturus Therapeutics und die STARR® sa-mRNA Arzneistoffherstellungstechnologien.
- Approval for domestic manufacturing sites enables local production control
- Integration of complete manufacturing process from ingredients to final products in Japan
- Commercial distribution capability established for domestic market
- None.
Insights
The approval for domestic manufacturing sites in Japan marks a pivotal development for Arcturus Therapeutics and its partners. This manufacturing expansion demonstrates several strategic advantages:
1. Supply Chain Optimization: The localization of KOSTAIVE® production in Japan significantly reduces logistics complexities and costs while enhancing supply chain reliability. This is particularly important for mRNA vaccines, which require specialized handling and temperature-controlled distribution.
2. Market Position Strengthening: By establishing domestic manufacturing capabilities through ARCALIS and Meiji Seika Pharmatech, Arcturus gains a stronger foothold in the Asian pharmaceutical market. This local presence could facilitate faster market response and potentially lead to expanded opportunities in the region.
3. Technology Transfer Value: The successful implementation of Arcturus's LUNAR® and STARR® technologies in Japanese facilities validates their transferability and scalability. This demonstration of technical expertise could attract additional licensing partnerships and technology transfer agreements.
4. Revenue Implications: The domestic manufacturing approval could positively impact Arcturus's revenue streams through:
- Reduced manufacturing and logistics costs
- Potential expansion of market share in Japan
- Additional technology transfer opportunities in Asia
- Strengthened positioning for future vaccine development projects
Meiji Seika Pharma and ARCALIS Co., Ltd. (Headquarters: Minami-soma City, Fukushima Prefecture; President: Satoshi Takamatsu) have been working together to establish an infrastructure that enables the integrated production of pharmaceuticals, from active ingredients to final products, within
“We are pleased with the approval of domestic manufacturing sites in
About sa-mRNA
mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.
About Meiji Seika Pharma
Meiji Seika Pharma, since it launched penicillin in 1946, has been providing efficacious and high-quality pharmaceutical products including therapeutics and vaccines for infectious diseases, therapeutics for central nervous system diseases and generic drugs, to meet various medical needs. (https://www.meiji.com/global/pharmaceuticals/)
About Arcturus Therapeutics
Arcturus Therapeutics Holdings Inc., founded in 2013, is a commercial mRNA Medicines and vaccines Company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases. (https://arcturusrx.com/)
About CSL Seqirus
CSL Seqirus, a subsidiary of CSL Limited, is one of the world's largest suppliers of influenza vaccines. The company has state-of-the-art manufacturing facilities in the
About ARCALIS
ARCALIS, Inc. is a joint venture company between Axcelead Inc. and Arcturus Therapeutics Inc., which owns a group of world-class drug-discovery and healthcare platform companies. The company provides drug discovery support, as well as a contract development and manufacturing business (CDMO business), for mRNA medicines and vaccines. (https://corp.arcalis.co.jp/en)
View source version on businesswire.com: https://www.businesswire.com/news/home/20250131312981/en/
Meiji Seika Pharma
Public Relations
Sayoko Taga
pr-pharma@meiji.com
Arcturus Therapeutics
Public Relations & Investor Relations
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com
Source: Arcturus Therapeutics Holdings Inc.
FAQ
What new manufacturing approval did Meiji Seika Pharma receive for KOSTAIVE®?
Which facilities are the new manufacturing sites for KOSTAIVE® in Japan?
What technologies are being transferred for KOSTAIVE® production in Japan?
Who managed the technology transfer for KOSTAIVE® manufacturing in Japan?
