The US Food and Drug Administration (USFDA) has approved China-based I-Mab Biopharma's Investigational New Drug for TJM2, a humanised immunoglobulin G1 targeting granulocyte-macrophage colony-stimulating factor for treating inflammatory diseases, it was reported yesterday.

The product is the first candidate from the company's proprietary range to be approved for clinical trials by USFDA.

Granulocyte-macrophage colony-stimulating factor is a critical pro-inflammatory cytokine that plays a pivotal role in tissue inflammation and destruction in autoimmune and inflammatory diseases. The product will be tested in clinical trials for its potential as a new treatment option for diseases such as rheumatoid arthritis and osteoarthritis.

The initial first-in-human single dose study will look at safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of the product in healthy volunteers, including Chinese subjects in the US.