Melbourne, Australia & Seoul, Republic of Korea — November 05, 2025 — Cell Therapies Pty Ltd (“Cell Therapies”), Australia’s leading cell and gene therapy (CGT) CDMO, and ENCell Co., Ltd. (“ENCell”), a Korea-based advanced biopharmaceutical CDMO, today announced the signing of a Memorandum of Understanding (MOU) aimed at expanding access to CGT development and manufacturing across the Asia-Pacific (APAC) region.

The partnership brings together the companies’ world-class GMP manufacturing facilities, technical and regulatory expertise, and extensive regional networks to accelerate the development and delivery of next-generation cell and gene therapies for patients across Asia-Pacific.

Strategic Focus Areas

Under the MOU, the companies will collaborate across four core areas that are critical to strengthening APAC’s CGT ecosystem:

1. Enhancing CGT Manufacturing and Process Development

Cell Therapies and ENCell will jointly optimize and scale manufacturing processes for a broad portfolio of advanced therapies, including MSC, CAR-T, CAR-NK, and iPSC-derived cell therapies. Collaboration includes shared use of GMP-certified facilities for global clinical and commercial supply and co-development of next-generation iPSC-based manufacturing platforms and decentralized production models.

2. Regulatory Alignment and Quality Harmonization

The partners will align regulatory strategies across Korea, Australia, Japan, and broader APAC jurisdictions. This includes co-preparation of manufacturing-related regulatory documents and sharing technical and quality expertise to support efficient regional and global submissions.

3. Joint Market Engagement and APAC Expansion

The companies plan to conduct joint business development activities targeting regional biotech and pharmaceutical firms, deepen partnerships with hospitals and research institutions, and build a trusted multi-site CGT manufacturing network capable of supporting global clients.

4. Workforce Development and Research Innovation

To support the rapid growth of CGT in APAC, Cell Therapies and ENCell will co-develop training programs to strengthen the talent pipeline and jointly pursue research initiatives in next-generation technologies such as allogeneic therapies, iPSC platforms, high-efficiency manufacturing systems, and sustainability-oriented production strategies. The collaboration will also explore cost-of-goods (COGS) optimization to improve long-term manufacturing efficiency.

Statements from Company Leaders

Dr. Bev Menner, CEO of Cell Therapies, emphasized the importance of the partnership:

“This collaboration represents a significant step toward enhancing patient access to innovative cell and gene therapies across the Asia-Pacific region. By working closely with ENCell, we aim to strengthen technical exchange, enhance manufacturing capacity, and establish a robust supply network to support the next generation of advanced therapies.”

Dr. Jong Wook Chang, CEO of ENCell, expressed confidence in the partnership’s value:

“ENCell fully supports Cell Therapies’ vision to expand the CGT ecosystem throughout the APAC region. By combining the expertise and manufacturing capabilities of both companies, we expect to establish a high-quality CGT production platform connecting Korea and Australia. ENCell will continue to collaborate with global partners to deliver optimal CDMO services that support successful clinical trials and commercialization for our clients.”

Advancing APAC’s CGT Ecosystem

This MOU is recognized as a model of meaningful cross-border collaboration, supporting the rapid expansion of the CGT industry in the APAC region. By leveraging each country's strengths and shared scientific capabilities, Cell Therapies and ENCell aim to enable regional biotech and pharmaceutical companies to advance their clinical and commercial pipelines with enhanced speed and reliability through a trusted CGT CDMO network.

The companies intend to progress to a definitive agreement within the next two to three months and will immediately begin identifying joint project opportunities and executing technical collaboration initiatives.