#Taiwan #Zhubei #Locus Cell #Cambium Bio #Elate Ocular

Locus Cell Establishes Strategic International Alliance

Locus Cell, a prominent player in the realm of regenerative medicine in Taiwan, has taken an important step forward by signing a Memorandum of Understanding (MOU) with Cambium Bio, an Australian firm. This agreement marks a significant milestone for Locus Cell as it represents their first international Phase III contract development and manufacturing (CDMO) project, specializing in the development of Elate Ocular®, a therapy aimed at treating dry eye disease.

A Leap Towards Global Expansion

The MOU, officially announced on September 29, 2025, outlines the collaboration whereby Locus Cell will handle the CDMO responsibilities for Cambium's Elate Ocular®-related products. This therapy is currently undergoing clinical trials in regions including Taiwan, the United States, and Australia, and is rooted in technology developed by Cambium's parent organization, Zheng Yang Biomedical Technology Co., Ltd.

Jiunn-Rong Chiou, Chairman of Locus Cell, expressed enthusiasm about the agreement, stating, “This MOU represents our first Phase III international CDMO project, a strong vote of confidence in our Zhubei smart GMP facility. It proves that our vision of 'rooted in Taiwan, serving global clients' is achievable.” This sentiment underlines the rapid progression of Locus Cell's capabilities within the international market, setting the stage for a broader future.

Integrating Global Standards

Locus Cell is prepared to meet the rigorous standards set forth by the U.S. FDA, incorporating systems such as electronic batch records and extensive traceability protocols within its operations. These measures enhance Locus Cell’s potential to seamlessly collaborate with pharmaceutical partners across the globe, but particularly in regions where stringent regulations are the norm. Furthermore, the facility is equipped with advanced technology that supports comprehensive environmental monitoring and ensures data integrity throughout production processes.

Cambium Bio's Vision for International Expansion

In tandem with the agreement with Locus Cell, Cambium Bio has also entered into a licensing MOU with Benta SAS, a French company, granting them rights to operate in the Middle Eastern and European markets concerning Elate Ocular®. This strategic move emphasizes Cambium's commitment to expanding its footprint internationally while relying on Locus Cell for the majority of its worldwide manufacturing and clinical operations. This partnership is strategic for both entities as it paves the way for quicker advancements in their respective projects.

Karolis Rosickas, CEO of Cambium Bio, noted the significance of this partnership, proclaiming, “Locus Cell's Zhubei smart GMP facility will meet FDA and GMP standards and is one of the few in Asia capable of both clinical and commercial production. Its digital-enabled stability and flexibility will lower costs, ensure quality, and strengthen competitiveness.” His statements highlight the operational excellence that Locus Cell brings to the table, indicating a positive outlook for the collaboration moving forward.

Future Prospects

As the global demand for innovative therapies continues to rise, the partnership between Locus Cell and Cambium Bio represents a beacon of strategic cooperation in the regenerative medicine sector. With Locus Cell’s commitment to quality and global standards combined with Cambium's innovative approach, stakeholders are optimistic about the successful deployment of Elate Ocular® and potentially beyond.

The alliance not only reinforces Locus Cell's role in the international supply chain but also solidifies Taiwan’s position in the global biomedical landscape. The momentum built through this MOU signifies just the beginning of what could be a transformative era for both companies in the ever-evolving field of regenerative medicine.