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WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization (CRDMO) in China, and Toregem BioPharma, a biotech startup company from Japan's Kyoto University, have signed a Memorandum of Understanding (MoU) to form a strategic partnership in the development of TRG035, a monoclonal antibody targeting USAG-1 for the treatment of congenital adentia.
Within the partnership, Toregem BioPharma will have access to WuXi Biologics' integrated CMC services in cell line development, cell banking and testing services, cell culture development, biologics GMP manufacturing, bioassay development, and related services. WuXi Biologics will support Toregem BioPharma on the TRG035 project for its Investigational New Drug (IND) application.
"By utilizing WuXi Biologics' comprehensive IND-enabling capabilities and large global footprint with extensive GMP production capacities, Toregem BioPharma will be able to focus on realizing and maximizing the therapeutic potential of TRG035. With WuXi Biologics we are conducting the clinical trial and for the eventual commercialization of our unique product. We look forward to bringing this tooth regeneration drug to the global market" said Dr Honoka Kiso, CEO of Toregem BioPharma.
Dr Chris Chen, CEO of WuXi Biologics, commented, "Toregem BioPharma is one of the first integrated CMC projects in Japan that we have supported from early academic research phase all the way to clinical phase. WuXi Biologics supports global partners in bringing new biologics solutions to global market"