Benzinga | Aug 30, 2021 04:02PM EDT

Ligand Pharma Partner Gloria Biosciences Receives Approval In China For Zimberelimab For Treatment Of Recurrent, Refractory Classical Hodgkin's Lymphoma

Ligand 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.

Zimberelimab 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.

"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."