Changchun High Tech's GenSci120 cleared for US clinical trials
Changchun High & New Technology Industry Group (SZSE:000661) announced today that its subsidiary, Changchun GeneScience Pharmaceutical (Jinsai Pharmaceutical), has received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for GenSci120 injection has met the criteria for implied approval. This allows Jinsai Pharmaceutical to initiate clinical trials of GenSci120 in the United States for the treatment of rheumatoid arthritis (RA). GenSci120 is a humanized PD-1 monoclonal antibody designed to inhibit or kill pathogenic T cells through specific targeted immune suppression. RA is a chronic autoimmune disease affecting approximately 0.27% of the global population. Jinsai Pharmaceutical intends to follow FDA requirements to advance the clinical trials, adding to the ongoing clinical trials in China for other indications.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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