GE Healthcare and Trinomab Announce Strategic Collaboration to Advance Industrialization of Natural Fully Human Monoclonal Antibodies in China

Zhuhai, China, Sept. 5, 2018 /PRNewswire/ -- GE Healthcare and Zhuhai Trinomab Biotechnology Co., Ltd. ("Trinomab") today signed a cooperation agreement. Under the agreement, GE Healthcare will build a FlexFactory™ biopharmaceutical production platform for Trinomab at the Zhuhai International Health Port and provide comprehensive technical bridge services. Meanwhile, GE Healthcare will join forces with its sister company, GE Capital, to tailor innovative sci-tech finance solutions for Trinomab, supporting the rapid deployment of advanced and flexible bioprocessing and production capabilities. This collaboration aims to accelerate the research, development, and industrialization of natural fully human monoclonal antibodies, empowering innovation and development in China's monoclonal antibody drug sector. This partnership not only marks the advent of an automated production platform for natural fully human monoclonal antibody drugs in China, but also represents GE Healthcare's first provision in the country of an integrated solution encompassing equipment, technical services, and financial support, demonstrating its leading strength in biopharmaceutical manufacturing.

FlexFactory™ Join ForcesFast Trak Building the Most Advanced Hardware Infrastructure and Technical Services

GE Healthcare’s FlexFactory™ production platform is a modern biopharmaceutical manufacturing platform based on single-use large-scale bioreactor serum-free cell culture technology, featuring advanced, integrated, and automated control for seamless integration. Using FlexFactory^TM The production platform enables the construction of a manufacturing facility for clients in just half the conventional timeline, equipping it with efficient cGMP-compliant biologics production capabilities. This accelerates the transition of drug candidates from R&D to clinical and commercial manufacturing, while enhancing production capacity and risk resilience. Compared to traditional facilities, it also significantly reduces upfront capital investment.

In addition to hardware facilities, the GE Healthcare BioProcess Technology Training Center in China (Fast Trak China) team will also provide comprehensive technical services to Trinomab as part of this collaboration. As one of GE Healthcare’s five global technology centers, Fast Trak China will partner with Trinomab to develop manufacturing processes for fully human monoclonal antibody drugs and support Trinomab’s clinical trial applications. The collaboration will cover upstream cell culture process development, downstream purification process development, analytical method development, establishment of quality standards, clinical trial material production, fill-finish implementation, and stability studies. More importantly, through comprehensive talent training and technology transfer, Fast Trak China will help Trinomab establish its own research and development and manufacturing capabilities.

Established in 1987, Fast Trak has been providing extensive technical services to China and the Asia-Pacific region since 2006. The Fast Trak China team comprises 30 experts specializing in chromatography, filtration, cell culture, biopharmaceutical manufacturing, and CMC regulatory submissions. Over the 12 years since its establishment, the team has leveraged its professional expertise to successfully complete more than 40 process development projects and 8 new drug clinical trial applications, covering blood products, recombinant proteins, vaccines, and antibodies.

Mr. Li Qing, General Manager of Greater China for GE Healthcare’s Life Sciences division, stated, “We are delighted to establish a partnership with Trinomab and, through our products and services, help enhance its production capacity, ultimately benefiting more patients with affordable, high-quality biopharmaceuticals. As a partner to Chinese biopharmaceutical companies, GE Healthcare remains committed to providing cutting-edge technologies, a comprehensive product portfolio, robust services, and rich, customized solutions to fully support the advancement of China’s biopharmaceutical industry.”

“Monoclonal antibody technology has undergone years of development, evolving from murine antibodies to human-mouse chimeric antibodies, and from humanized antibodies to fully human monoclonal antibodies. Each advancement has been driven by the tremendous efforts of countless professionals. Our strategic partnership with GE enables us to further advance HitmAb^®“...advancing the fourth-generation natural fully human monoclonal antibody technology, represented by this technology. We believe that such collaborative progress will help us pioneer a new landscape in monoclonal antibody development, enabling our endeavors to benefit the public more rapidly,” said Dr. Liao Huaxin, Chairman and CTO of Trinomab.

Sci-Tech Finance InnovationAccelerating R&D Progress, Empowering the Future of Life Sciences

Equipment procurement and clinical trials are the two largest capital expenditures faced by early- and mid-stage biopharmaceutical companies. To help Trinomab accelerate its R&D process, GE Industrial Finance has created a tailored innovative financing solution for Trinomab, maximizing customer satisfaction while breaking through traditional financing models in the biopharmaceutical industry.

GE Industrial Finance has tailored a financial solution for Trinomab by integrating the production cycle of GE Healthcare’s FlexFactory™, the unique characteristics of the Fast Trak technical service program, and Trinomab’s need for accelerated R&D. With only a small amount of initial capital, Trinomab can rapidly deploy GE Healthcare’s advanced FlexFactory™ production platform and receive comprehensive technical support from Fast Trak. This approach allows the client to conserve capital, prioritizing its use for clinical trials or other strategic needs, thereby accelerating drug development and enhancing the flexibility and efficiency of capital utilization. Meanwhile, the structure maximizes the use of debt financing to ensure the maximization of shareholder value. This project represents a best practice in GE Industrial Finance empowering GE Healthcare’s life sciences customers by providing full-lifecycle financial solutions.

Mr. Zheng Weihong, CEO and President of Trinomab, stated, “Trinomab’s rapid and successful transformation from a biotechnology company to a biopharmaceutical enterprise has been made possible by our comprehensive collaboration with GE. Our partnership encompasses not only technical cooperation with GE Healthcare but also financial collaboration with GE Capital. Backed by GE’s integrated solutions, many of Trinomab’s ongoing R&D projects are poised for swift translation into production in the near future, thereby benefiting more patients who currently lack available therapeutic options. This model positions the company on a virtuous path of accelerated growth. We are deeply grateful to GE for its tailored solutions.”