— The first I-Mab proprietary drug candidate to enter clinical trials in the United States
SHANGHAI, Dec. 24, 2018 /PRNewswire/ — I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, today announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF), with the best-in-class potential to treat autoimmune and inflammatory diseases.
TJM2 is the first candidate from I-Mab’s innovative proprietary pipeline to be approved for clinical trials by the FDA. GM-CSF is a critical pro-inflammatory cytokine that plays a pivotal role in tissue inflammation and destruction in autoimmune and inflammatory diseases. TJM2 will be tested in clinical trials for its potential as a new treatment option for diseases such as rheumatoid arthritis and osteoarthritis.
“We are delighted to receive this IND approval from the FDA to start clinical studies with TJM2 in the United States. This is another important milestone for I-Mab’s global strategy and a strong testament to I-Mab’s in-house research capability to develop highly innovative biologics for patients around the world,” said Jingwu Zang, CEO of I-Mab.
The initial first-in-human (FIH) single dose study will look at safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of TJM2 in healthy volunteers (including Chinese subjects) in the United States.
I-Mab is a dynamic and fast-growing global company exclusively focused on developing first-in-class and best-in-class biologics in the areas of immuno-oncology and autoimmune diseases through internal R&D capabilities and global partnerships. I-Mab’s pipeline is driven by the company’s development strategy to address unmet needs in China and to bring innovative assets to the world. The company is on track to initiate additional clinical trials in China and the U.S., including multiple Phase II and Phase III studies. I-Mab is on a fast track towards becoming an end-to-end fully integrated biopharma company. The company has been well-recognized by capital markets with the recent $220 million Series C financing representing one of the largest amounts ever raised by an innovative biotech company in China. www.i-mabbiopharma.com
Associate Director of Public Relations
Head of US site
View original content:http://www.prnewswire.com/news-releases/i-mab-receives-us-fda-ind-approval-for-proprietary-anti-gm-csf-monoclonal-antibody-tjm2-300770567.html