Posted by Michael Wonder on 21 Jul 2021
Sorrento announces its partner Mabpharm has received marketing approval in China for infliximab biobetter
20 July 2021 - Sorrento to exclusively market the product outside of China including US, Japan and Europe.
Sorrento Therapeutics announced today that its partner Mabpharm has received approval of its new drug application for its infliximab biobetter antibody in China.
Sorrento holds exclusive commercial rights to this product outside of China and plans to file a biologics license application for the infliximab biobetter antibody in the United States and Europe in 2021.
Mabpharm’s approved biobetter is an anti-TNF-α antibody using a CHO expression system, resulting in a better safety profile and lower immunogenicity when compared to the currently marketed TNF-α antibody using a murine cell line, while demonstrating the same efficacy as the parent mouse antibody. The Chinese approval covers 6 different indications including adult ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, adult and childhood Crohn’s disease, fistula Crohn’s disease, and psoriasis.
