On Jul. 20, 2020, Sorrento announced that its partner Mabpharm had 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 (BLA) for the infliximab biobetter antibody in the United States and Europe in 2021.

Infliximab (currently marketed under the trade name Remicade) is an injectable monoclonal antibody prescription drug used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis (a type of spinal arthritis), psoriatic arthritis, and the red, scaly skin patches of plaque psoriasis. Infliximab belongs to a class of drugs called tumor necrosis factor (TNF) inhibitors, which work by suppressing the action of a protein called TNF that is linked to inflammation. It is usually prescribed when other medicines or treatments have failed. Global sales revenue of infliximab in 2020 reached $4.2 billion, making the antibody one of the top 20 blockbuster drugs.

Mabpharm’s approved biobetter is an anti-TNF, antibody using a CHO expression system, resulting in a better safety profile and lower immunogenicity when compared to the currently marketed TNF-a 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.

Sorrento was planning to meet with FDA and EMA to discuss the data package and gain concurrence on the path forward to a BLA or MAA.