Novartis Secures Chinese Clinical Approval for Two First-in-Class Antibody Therapies Targeting TIM-3 and TGF-β

On March 29, the CDE website announced that two Class 1 biological new drugs from Novartis had received implied permission for clinical trials. These are the monoclonal antibody MBG453 targeting the TIM-3 receptor and the anti-TGF-β monoclonal antibody NIS793, both indicated for lower-risk myelodysplastic syndromes.

MBG453: A Monoclonal Antibody Targeting the TIM-3 Receptor

TIM-3 is a negative regulatory immune checkpoint present in different types of immune cells. The TIM-3 signaling pathway plays an important role in the regulation of T-cell activity and quantity, and is involved in tumor immune suppression and progression by mediating cell apoptosis. The TIM-3 receptor is mostly expressed on the surface of immune cells and myeloid leukemia cells, and its level is associated with the severity of acute myeloid leukemia and myelodysplastic syndromes.

Public information shows that MBG453 (sabatolimab) is a potential "first-in-class" monoclonal antibody developed by Novartis, targeting the TIM-3 receptor. By inhibiting the function of the TIM-3 receptor, this candidate drug can simultaneously target myeloid leukemia cells and immune cells, not only killing cancer cells but also potentially enhancing the activity of immune cells.

NIS793: Anti-TGF-β Antibody

The transforming growth factor β (TGF-β) signaling pathway primarily participates in mediating the normal growth and development of tissues and organs, as well as the body's immune responses, by regulating processes such as cell growth, proliferation, differentiation, migration, and apoptosis.

NIS793 is a potential "first-in-class" fully human anti-TGF-β IgG2 monoclonal antibody developed by Novartis. It can inhibit the TGF-β pathway in tumor cells and modulate the tumor microenvironment, reversing immunosuppression and fibrosis. The ClinicalTrials website shows that Novartis is conducting multiple clinical trials of NIS793 worldwide, involving indications such as metastatic pancreatic ductal adenocarcinoma, metastatic colorectal cancer, myelofibrosis, and myelodysplastic syndrome. Among these, the study of NIS793 for treating pancreatic ductal adenocarcinoma has progressed to phase 3 clinical trials.

Source: CDE official website, Pharma Observer