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Samsung and TG Therapeutics have expanded their 2018 contract manufacturing deal for the supply of TG’s ublituximab, an investigational anti-CD20 monoclonal antibody.
Samsung Biologics announced on April 26, 2021 that it has expanded its 2018 contract manufacturing deal with TG Therapeutics, a US based healthcare company, for the supply of TG’s ublituximab, an investigational anti-CD20 monoclonal antibody (mAb).
Since the start of the collaboration, TG has completed a rolling submission of a biologics license application to FDA requesting approval of ublituximab, in combination with ukoniqtm (umbralisib), TG’s oral once-daily inhibitor of PI3K-delta and CK1-epsilon for the treatment of chronic lymphocytic leukemia, Samsung said in a company press release. The mAb was also involved in two successful Phase III clinical trials directed at patients with relapsing forms of multiple sclerosis (MS).
“We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities,” said John Rim, CEO of Samsung Biologics, in the press release. “By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world and getting a step closer to our vision of bringing about a better life for humanity.”
“Samsung is the global leader in biologics manufacturing, and we are happy to have them as our partner as we look forward to the potential commercialization of ublituximab across both oncology and autoimmune indications,” added Michael S. Weiss, executive chairman and CEO of TG Therapeutics, in the press release. “With the recent positive Ultimate I and II MS Phase III studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab. This is an important next step in our long-standing relationship with Samsung.”