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Ligand’s Partner Gloria Biosciences Receives Approval in China for Zimberelimab for the Treatment of Recurrent or Refractory Classical Hodgkin’s Lymphoma
First regulatory approval of an OmniAb-derived antibody EMERYVILLE, Calif.--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today
About this update from Ligand Pharmaceuticals Incorporated
[{"type":"text","content":"\nFirst regulatory approval of an OmniAb-derived antibody\n\n EMERYVILLE, Calif.--(BUSINESS WIRE)--\nLigand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its partner Gloria Biosciences (GloriaBio) has received approval from China’s National Medical Products Administration (NMPA) for zimberelimab (GLS-010), an OmniAb-derived anti-PD-1 monoclonal antibody for the treatment of recurrent or refractory classical Hodgkin’s lymphoma (cHL). GloriaBio has development and commercialization rights in China with respect to zimberelimab through a sublicense agreement with Ligand's licensee Wuxi Biologics Ireland Limited.\n\nZimberelimab is a fully human monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in the downregulation of the immune system by preventing the activation of T cells. Other anti-PD-1 antibodies have been approved by the U.S. FDA in multiple cancer types. In addition to cHL, GloriaBio is investigating zimberelimab in advanced solid tumors and in March 2021 was granted Breakthrough Therapy Designation for the treatment of patients with recurrent or metastatic cervical cancer in China. Zimberelimab is being developed by Arcus Bioscience in North America, Europe, Japan and certain other territories through a 2017 license agreement.\n\n“We are delighted to see GloriaBio’s progress with zimberelimab including receipt of NMPA approval. When we acquired the OmniAb technology in 2016, there were no OmniAb-derived antibodies in the clinic. GloriaBio’s approval just five years after our acquisition and just four years after they entered the clinic is truly impressive,” said John Higgins, CEO Ligand Pharmaceuticals. “Approval of this OmniAb-derived antibody represents the first of many regulatory events we expect over the coming years from what we believe is the industry’s best-in-class antibody discovery engine. Indeed, this is our biggest year ever for regulatory approvals for our partnered products.”\n\nAbout Zimberelimab\n\nZimberelimab is a fully human monoclonal antibody that binds to PD-1, restoring the antitumor activity of T cells. GloriaBio contracted with Ligand’s partner WuXi Biologics to discover and develop GLS-010 using Ligand's transgenic rat platform, OmniRat®...