I-Mab Biopharma Receives IND Approval from NMPA to Initiate Clinical Trials for its Anti-GM-CSF Monoclonal Antibody TJM2 in China
SHANGHAI, China – November 14, 2019 – I-Mab Biopharma (“I-Mab”), a China and U.S.-based clinical-stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases today announced that National Medical Products Administration (NMPA) approved its IND application for TJM2 to conduct clinical trials in patients with rheumatoid arthritis (RA). TJM2 is a humanized immunoglobulin G1 (IgG1) neutralizing antibody targeting the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) with the potential to treat patients with autoimmune and inflammatory diseases in which GM-CSF plays a critical role.
TJM2 is the first in-house developed drug candidate from I-Mab’s global portfolio of internally developed candidates to have entered clinical trials. Earlier this year, I-Mab conducted a first-in-human phase 1 clinical trial with TJM2 in healthy volunteers in the U.S. (NCT03794180). Having successfully completed that trial, I-Mab filed an IND with the NMPA for TJM2 in patients with RA and, subsequently, received regulatory clearance on November 8. The current phase I study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of TJM2 in patients with RA.
“We believe TJM2 has broad potential for the treatment of patients with autoimmune and inflammatory diseases and are pleased to have obtained clearance from the Chinese health authorities to continue further clinical development of TJM2 in RA patients in China,” said Jingwu Zang, MD., PhD., Founder and Honorary Chairman of I-Mab Biopharma. “This is an important milestone for I-Mab and demonstrates our ability to conduct clinical trials in both the U.S. and China and leverage data between the countries to expedite our clinical development programs in our goal to bring innovative products to the patients.”
About I-Mab:
I-Mab is a dynamic, global biotech company exclusively focused on developing biologics of novel or highly differentiated in the therapeutic areas of immuno-oncology and autoimmune diseases. I-Mab's mission is to bring transformational medicines to patients through innovation. I-Mab’s innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company’s Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to become a fully integrated end-to-end global biopharmaceutical company with cutting-edge discovery platforms, proven preclinical and clinical development expertise, and world-class GMP manufacturing capabilities. I-Mab is well-recognized by capital markets to have successfully raised over US $400 million in equity financing since its establishment in 2016. Its recent US $200 million Series C financing represents one of the largest amounts ever raised by a biotech company in China.
For more information, please see the Company's website at www.i-mabbiopharma.com