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.
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Ono partners with Shattuck Labs for bifunctional fusion proteins
Artax Biopharma doses first subject in AX-158 Phase 2a psoriasis trial
Bio-Thera Solutions commences dosing in BAT6026 Phase IA/IIB clinical trial
BioSenic expands patent coverage for ATO therapeutic platform
Celltrion USA submits CT-P47 Biologics License Application to FDA
NS Pharma's NS-229 receives European Commission orphan drug designation
Kyverna Therapeutics' KYV-101 granted US FDA fast track designation
InnoCare Pharma receives U.S. FDA clearance for ICP-248 clinical trial
Biosenic finalises agreement with Phebra for oral arsenic troxide development
Guangzhou Fermion Technology's FZ008-145 IND application receives Chinese regulatory approval
Allorion Therapeutics signs exclusive option and global license agreement with AstraZeneca